P = 0.027). The pattern changed significantly at 8 h and 12 h for general anaesthesia's efficacy . A higher VAS score was observed in pT2 patients. Patients with resected tumour volume >10 cm3 exhibited a VAS score >3 at 8 h and 24 h . Multifocality of bladder tumours induced more pain overall. It seems that spinal anaesthesia is more effective during the first 2 postoperative hours, while general prevails at later stages and at larger traumatic surfaces. Finally, we incidentally found that tumour stage plays a significant role in postoperative pain, a point that requires further verification.We compared the analgesic efficacy of spinal and general anaesthesia following transurethral procedures. 97 and 47 patients underwent transurethral bladder tumour resection (TUR-B) and transurethral prostatectomy (TUR-P), respectively. Postoperative pain was recorded using an 11-point visual analogue scale (VAS). VAS score was greatest at discharge from recovery room for general anaesthesia ( Pain management during transurethral procedures is a major concern. Apart from the standard general anaesthesia, regional anaesthesia is also extensively applied. Nevertheless, the administered type of anaesthesia is ultimately based on the anaesthesiologist's decision. Regional anaesthesia is divided in epidural, spinal, and saddle blockade anaesthesia. Recently, local anesthesia with infiltration of the bladder wall or periprostatic nerve blockage was reported –3. AdditThe selection of anaesthesia in a transurethral prostatectomy (TUR-P) or a transurethral bladder tumor resection (TUR-B) has been investigated meticulously in previous reports –8. In geAll patients provided informed consent, before being included in the study. Distribution of the patients is depicted in the CONSORT flow diagram  Figure . Patient2O at 50% O2) and inhaled desflurane at MAC 1 (Minimum Alveolar Concentration). Spinal anaesthesia was administered as a single shot of 2 mL bupicaine and 1 mL lidocaine without adrenaline. Patients with bladder or prostatic capsule perforation, which was identified intraoperatively, were excluded from the study. A 22-F, 3-way Dufour catheter was placed in all patients, and bladder irrigation was standard. Bladder irrigation was stopped after the completion of the 24-hour observation period after verifying the absence of intravesical clotting by manual irrigation and suction. Patients needing further irrigation were also excluded.Conventional transurethral procedures were performed using standard resectoscopes and electrocautery. No preemptive analgesia was administered. Induction to general anaesthesia was done with the intravenous (I.V.) administration of 1-2 g/kg of propofol, followed by 1-2 mg/kg of fentanyl along with 1-2 mg/kg of suxamethonium. Maintenance of anaesthesia was achieved with the I.V. administration of 0.5 mg/kg of atracurium . The VAS was given to each patient at the time of his/her arrival in the recovery room, which was considered as hour 0. Each patient recorded his/her pain tolerance at postoperative hours (h) 0, 2, 4, 8, 12, and 24. No pain scored 0 points, while worst possible pain for the patient was scored with 10 points. The pain scoring was reviewed by an anesthesiologist.In cases with VAS scale score > 3 during the observation period, 500 mg of paracetamol combined with 20 mg of hyoskine N-butylbromide (Buscopan) were administered. Stratification of pain scoring was made using several parameters, such as age, gender, stage, grade, and location of the TCC's.U test for continues variables and the chi-square test for categorical variables. Odds ratios were used to quantify the strength of association between variables. Kruskal-Wallis test was used to estimate equality of population medians among groups and the Mann-Whitney U test for comparison between the groups. The Spearman correlation coefficient (when appropriate) was used to examine the independence between categorical variables. Results were considered significant if P < 0.05.Statistical analysis was performed using the SPSS 14.0 for Windows statistical package . Clinical and demographical characteristics were compared using the Mann-Whitney P = 0.027). At 8 h and 12 h, general anaesthesia's analgesic efficacy was increased significantly  VAS scores, with 95% confidence interval (CI) in relation to postoperative time are shown in P = 0.021 and P = 0.032)]. However, in the female patients, VAS score was distributed differently, since spinal versus general anaesthesia's analgesic efficacy was lost at 4 h [median (95% CI) 3 (0–4) versus 0 (0–3)], 8 h [2.5 (0–3) versus 0 (0–2)] and 12 h [2 (0–2) versus 0 (0-1)] , suggesting a better analgesic efficacy for general anaesthesia.After adjusting for gender in the TUR-B group, male patients under general anaesthesia experienced more pain at 0 h and 2 h . This pattern changed at 8 h [2.5 (0–8) versus 0.5 (0–2) (P = 0.039)] and at 12 h, [2 (0–8) versus 0 (0–2) (P = 0.016)]. A separate analysis was performed in male patients comparing TUR-P versus TUR-B. No difference in VAS score was recorded between the two surgical approaches when general anaesthesia was chosen as analgesic method. In the spinal group, however, TUR-B patients presented lower mean VAS score than TUR-P patients at 0 h  and >10 cm3 mean 28.1 (11–40) (n = 15)]. The cut-off point of 10 cm3 was set by the statistical analysis. Those with resected tumor volume > 10 cm3 presented VAS score >2 at 8h and 24 h, which was statistically significant  . However at 24 h, VAS > 3 was more common in patients with tumor volume <10 cm3 who underwent general anaesthesia . Resected tumor volume was used as a categorical variable, and patients were divided in those with <10 cm, resp.) . AdjustiFinally, location of the bladder tumor was also examined. Apart from the 24 h, tumor located in the lateral bladder walls induced more pain than those situated in the trigone. Moreover, tumor multifocality had the highest VAS scores in all observation periods .The majority of published reports investigate the results of general and spinal anaesthesia separately. Several papers compare the effect of these methods in terms of peri- and postoperative morbidity  . To our Several interesting and novel points were drawn from the statistical analysis of our data. Firstly, in patients undergoing TUR-P, we found that none of the 2 methods of anaesthesia prevailed during the 24-hour observation period. Reeves and Myles reported a similar result using a 5-point verbal rating scale. This result however, described the satisfaction with analgesia and not the pain level . AnotherOn the other hand, differences were recorded in TUR-B patients. To be more specific, spinal was more efficient than general anaesthesia in the first 2 h after surgery, while general proved to be better in the later time points. This fact can be explained by the major implications induced in bladder function by regional anesthesia. Indeed, catheter-related pain and detrusor muscle spasm elicited by bladder irrigation can be managed efficiently with regional anaesthesia in the first 2 postoperative hours. However, it simultaneously causes a clinically significant disturbance of bladder function due to interruption of the micturition reflex . AdditioThe above urodynamic effects might be interpreted better in the female patients than in men, since in women there are no prostatic symptoms that could bias the bladder pain, and we should also acknowledge the fact that females perceive pain better than men, as recent reports suggest . In the A very surprising observation is exhibited in the statistical analysis, concerning the bladder tumor stage. Patients with higher stage experienced a higher level of pain than the ones with localized disease (pTa-pT1). No adequate explanation of this phenomenon is provided by the current literature. One can speculate that infiltrative disease stimulates more nociceptors  . Even th3 are resected. It is rational to believe that a larger traumatic surface elicits more pain. On the other hand, when we adjusted our analysis to the type of anaesthesia, general anaesthesia seemed to be more efficient at 4 h and 24 h. Tumor volume was the only parameter favoring the efficiency of general anaesthesia independently of the postoperative time of observation.We also found that the resected bladder tumor volume becomes a significant parameter of pain induction after a TUR-B, when more than 10 cmThe use of VAS scale for the documentation of pain measurement introduces a study bias per se, since this is a subjective method. To date, no objective recording of pain perception has been described, even though several pain scales assessing the patient's agitation level by recording the facial expression, leg movement, and muscle tension, or even the brain electrophysiologic activity through specialized electroencephalograms (EEG) are presented as promising . Yet, paOne comment should be also made about pharmacokinetics. The dosage of epidural regimens has an effect of approximately one and a half hours. Therefore, it could not have altered the VAS scoring, since the 0 h point was set at the arrival in the recovery room. The selection of paracetamol and hyoskine N-butylbromide as rescue analgesics in patients, reporting VAS > 3 postoperatively, was made due to their immediate action and their short half-lives , 23, whiThis study is not without limitations. The patients were not randomized due to the fact that the selection of analgesia was made by the anaesthesiologists individually for each patient, according to their performance status. Another drawback could be the lack of analysis of the time of the operation and the prostatic volume resected. Even though the resected adenoma cannot be rationally associated with pain induction, since the major causes of TUR-P pain are bladder spasm, catheter-related pain, and capsule offense, a future study could incorporate this parameter. As for the time of the operation, we believe that it could not have affected the result, since the scoring started after the completion of the operation, during which pain is managed sufficiently.The analysis of the advantages and disadvantages of regional compared to general anaesthesia is immensely complicated. As can easily be imagined, the secondary effects of both types of anaesthesia are varied, and realistically, they must be considered for each and every patient, due to the unique clinical profiles presented. This study attempted to establish the potency of general and spinal anaesthesia during transurethral procedures by recording the patient's pain perception. It seems that spinal anaesthesia is more effective during the first 2 postoperative hours, while general prevails at later stages and at larger traumatic surfaces. Finally, we incidentally found that tumor stage plays a significant role in postoperative pain, a point that requires further verification. We advocate a closer cooperation of the urologist with the anaesthesiologist in terms of providing more specific information about the patient's disease and tailoring the type of anaesthesia to the patient's needs.


Purpose. In a randomized, double-blind trial, the efficacy of nonopioid analgesics on postoperative piritramide consumption was compared for pain relief during the first 24 h in patients recovering from arthroscopic knee surgery. Methods. 120 patients were treated with normal saline and/or one of the nonopioid analgesics  in addition to piritramide using the PCA pump. Beginning in the postanesthesia care unit (PACU), patients were asked to quantify their pain experience at rest while piritramide consumption was recorded. Results. Piritramide consumption upon arrival in the PACU was high in all groups. However, cumulative consumption in the parecoxib group was significantly lower than that in the placebo group at 6 and 12 h after surgery. At discharge from the PACU, VAS scores dropped in all groups and were significantly lower in the parecoxib group. In the PACU, satisfaction of the patients was moderate and improved with time after surgery. Conclusions. There was statistically significant opioid-saving effect by administering parecoxib with better VAS scores and satisfaction level compared to placebo. The high pain score in the PACU in all groups immediately after recovering from remifentanil-based anesthesia would be prevented if local anesthetics were administered intra-articularly as part of a multimodal analgesic approach. Arthroscopic knee surgery belongs to those procedures with the highest incidence of moderate to severe pain for the first 24 hours postoperatively . A varieAlthough the majority of PCA studies was conducted with morphine –12, onlyThe selected non-opioid analgesics including parecoxib, metamizole (dipyrone), and paracetamol are routinely used for the IV treatment of postoperative pain in Germany. Both parecoxib and metamizole are considered nonsteroidal anti-inflammatory drugs (NSAIDs), albeit one is a selective COX-2 inhibitor while the other is not selective. Parecoxib is the only parenterally administered selective COX-2 inhibitor which has the most supportive data for its beneficial effects as a part of multimodal analgesia and offers benefits with regard to its adverse effect profile , 21. MetSince there is obviously no randomized study that compares IV administered parecoxib versus metamizole (dipyrone) or paracetamol (acetaminophen) on piritramide consumption in the early postoperative period of arthroscopic knee surgery, the aim was therefore to perform a prospective, randomized, double-blind, placebo-controlled study in patients undergoing arthroscopic knee surgery. The primary objective was to compare postoperative piritramide consumption alone or in combination with parecoxib, metamizole, or propacetamol (paracetamol) for providing pain relief in adult patients recovering from arthroscopic knee surgery during the first 24 hours. Secondary outcomes included pain intensity and patient satisfaction.The investigative protocol was approved by the institutional review board at our teaching hospital on December 9, 2003, and all patients provided written informed consent before enrolment. The study began in March 2004 and ended in August 2007. Inclusion criteria were the following: patients in the age between 18 and 75 years and ASA physical status I–III who underwent specific arthroscopic knee surgery under tourniquet. Patients undergoing ambulatory knee surgery as well as patients with a history of significant cardiac, pulmonary, hepatic, or renal disease, morbid obesity, chronic pain and drug or alcohol abuse, and contraindications or previous adverse reaction to any of the drugs used in the study were excluded. Also not included were patients unable to cooperate.http://www.randomization.com/)  .The four study groups were placebo, parecoxib, metamizole, and paracetamol . Since nThe study solutions were prepared by one of the researchers who was not involved in the intraoperative and postoperative treatment of these patients, so the drugs could not be recognized by the anesthesiologists administering them and collecting the data. The observation time extended over a period of 24 hours after surgery. However, to ensure patient safety, a sealed opaque envelope containing the randomized treatment assignment was kept with each patient in the operating room and the ward to permit immediate unmasking in case of an emergency making this step necessary.μg/kg/h remifentanil for an adequate depth of anesthesia with mean arterial pressure and heart rate within 20% range of preoperative values.For premedication, midazolam 7.5 mg was administered orally 60 min before the surgical procedure. On arrival in the operating room, standard monitors were applied and a crystalloid infusion was started after placing an 18-gauge catheter in the nondominant hand for fluid administration intraoperatively. A second 18 G catheter in the other hand was used for the administration of anesthetic drugs and removed upon discharge from the postanesthesia care unit (PACU). After preoxygenation and precurarization, anesthesia was induced with 2 mg/kg propofol intravenously, followed by 1–1.5 mg/kg BW suxamethonium chloride to facilitate endotracheal intubation. Anesthesia was maintained with a supplemental infusion of 3–6 mg/kg/h propofol and 3–10.5 Fifteen minutes before the expected end of surgery, each patient was treated according to the list of randomization . The preThereafter, the patients were directly transferred to the PACU, where further clinical observations were done by an independent, blinded observer who was unaware of the administered study drugs. On arrival, postoperative pain was treated by self-administration of small doses of IV piritramide using the PCA pump already mentioned and patients were asked every 2 hours for the first 6 hours and afterwards once every 6 hours to quantify their pain experience at rest on a visual analog scale (VAS) between 0 and 10, with 0 representing no pain and 10 the worst imaginable pain. Likewise, pain relief was assessed by the patient on a 0–3 verbal rating scale (VRS) . Patient satisfaction with the effectiveness of pain therapy was inquired at 6-hour intervals by using a 4-point scale which shows the verbal expressed satisfaction of assigned numerical values: 1 = poor, 2 = moderate, 3 = good, 4 = very  good. The cumulative piritramide consumption within 24 hours postoperatively was recorded at discharge from the recovery room and after 6, 12, and 24 hours on the display of the PCA pump.β-risk of 80% at an alpha level of 0.05 for detecting a difference in piritramide consumption of at least 5.0 mg at 24 h after the operation with a standard deviation of 7.0 for each group in the preliminary test.Data were first entered into Excel 2000 and then imported into SPSS for Windows Version 15.0  for calculations. An estimated sample size indicated that 30 patients per group would give a P < 0.008. Categorical data were analyzed using χ2 or Fisher's exact test as appropriate. Differences were judged significant at P < 0.05.For examination of the normal distribution, the Kolmogorov Smirnov test was applied. One-way analysis of variance (ANOVA) in normal-distributed continuous variables and Kruskal-Wallis's test in non-normal-distributed or ordinal variables between the groups were used. If there was a statistically significant difference between groups as determined by one-way ANOVA post-hoc tests (Bonferroni) were used to confirm where the differences occurred between groups. If the Kruskal- Wallis's test value was significant at the 0.05 level, groupwise comparisons were performed using Mann-Whitney rank sum test for unpaired data. Significant Mann-Whitney values were Bonferonni corrected with the factor for the number of comparisons resulting in a significance level set at The four groups were similar with respect to age, body mass index (BMI), ASA physical status, total remifentanil consumption, and duration of anesthesia . The typP = 0,033) and 12 h  after surgery. Apart from signs of mild nausea and vomiting, no further drug reactions were observed.The incremental piritramide consumption showed no significant differences at all times between the four groups . Upon arP < 0.006). Further significant differences between the groups were found at 12, 18, and 24 h after surgery. VAS scores were lowest in the parecoxib group at all measuring times.VAS pain scores for all groups are presented in In the PACU, satisfaction of the patients assessed on the 4-point scale was moderate and improved with time after surgery . SatisfaOur findings show that pain was most intense immediately after recovering from remifentanil-based anesthesia for arthroscopic knee surgery and subsequently declined to low levels in all groups within 24 h after surgery. The early intense pain might be partly explained by a bolus dose of 2 mg piritamide with a lock-out time of 10 min which has been routinely prescribed in Germany . Such smA significant reduction in cumulative piritramide consumption was only shown in the parecoxib group compared to the NaCl group at 6 and 12 hours following arthroscopic knee surgery under general anesthesia. These results are in accordance with the data published in 2006, where in a 24 h study, cumulative opioid consumption was significantly reduced in the celecoxib group compared with the placebo group at 10 to 12 hours in patients undergoing ambulatory arthroscopic knee meniscectomy . After tApart from the statistically significant superiority of parecoxib in combination with piritramide given over a PCA after arthroscopic knee surgery, also the VAS pain scores were significantly lower in the parecoxib group as compared to placebo at discharge from the PACU, 2 hours after admission, and between parecoxib and paracetamol at 12, 18 and 24 h after surgery. However, VAS scores after 12 h were all ≤3, thus implying low pain intensity without the need for piritramide in most patients. Therefore, it might be difficult to demonstrate an additional benefit with an analgesic when baseline pain was already low. No drug reactions apart from mild nausea and vomiting, which were treated with antiemetics, occurred in our study.A limitation of this study is that the trial was concluded in 2007 and that postoperative pain management may have changed from 2007 until now, which limits the generalizability of our findings. In addition, we used drugs which are not available in all countries. Also, we did not use the standard doses for metamizole and paracetamol recommended by the manufacturers. We had compared subtherapeutic doses for metamizole and paracetamol which are not equivalent to parecoxib. Furthermore, pain intensity was evaluated only at rest, and movement-related pain relief was not included in this study. In addition, the results might have been different if nonopioid analgesics had been given prior to surgery as preemptive analgesics. A comparison of the combined use of different drug classes (NSAID and paracetamol) given simultaneously as part of a multimodal treatment as in other studies might be worthwhile.There was statistically significant opioid-saving effect only by administering parecoxib. The high pain score in PACU in all groups immediately after recovering from remifentanil-based anesthesia would be prevented if a local anesthetic solution was administered intra-articularly in all groups as part of a multimodal analgesic approach.


Objective. To confirm safety and feasibility of double J stent insertion under local anesthesia and to assess the effect of detailed explanation and observing double J stent insertion on pain experience of male patients. Material and Methods. Eighty consenting males, randomized and divided prospectively into group A, who were allowed to observe DJ stent insertion, and group B, were not observed. All DJ stent insertions were done by senior urologist in operating urology room with or without fluoroscopy guidance. At the end of the procedure the vital signs and duration of the procedure were documented and patients were asked to fill unmarked 100 mm visual analogue pain scale (VAS) as soon as the surgeon leaves operating room. Results. Mean age of entire study group was 38.8 years; the majority of the patients had DJ stent insertion for obstructed ureteric stone, with uneventful outcomes. Postprocedural systolic blood pressure and mean pain using VAS showed statistically significant difference between groups A and B. Conclusion. DJ stent insertion under local anesthesia is a safe and feasible procedure. We recommended self-watching and detailed explanation to patients who underwent DJ stent insertion to reduce the pain and anxiety associated with the procedure. Double J (DJ) ureteric stent insertion under general anesthesia (GA) is more frequent procedure in daily work of our urology department. Furthermore this trend of practice will be at expense of inpatient beds availability and staffs dependent.The modern cystoscopic double J ureteric stent insertion was first described in 1978, which was traditionally performed under general anesthesia on inpatients [The reliance on GA for this procedure in acute setting can delay the time to stent placement, depending on staff and resources availability .Moreover, the GA is not without limitations and risk especially in obese, elderly, or those with cardiovascular comorbidities. Airway trauma, swelling, vocal cord paralysis, bronchospasm, aspiration, and death from improper intubation all are reported complications of endotracheal intubation . Despite the advancement in endourology field, studies describing the safety and feasibility of DJ stent insertion under local anaesthesia are few and did not assess the pain experience –7.The concept of distraction using music, detailed explanation and viewing the procedure during endoscopies is not new.It is used to reduce pain and anxiety during minimally invasive operation, for example, bronchoscopy, colonoscopy, colposcopy, and cystoscopy –11.Recently, five randomized controlled studies regarding effects on pain of patients watching cystoscopy procedure have been published. Soomro et al., Patel et al., and Clements et al. observed a reduction in pain level in patient group allowed to view their procedure. Contradicting these findings, Cornel et al. and Kesari et al. found no difference in pain and anxiety level between two groups , 12–15.Pain is a subjective feeling; however, it can be measured indirectly using visual analog scale (VAS) and autonomic changes such as tachycardia, hypertension, lacrimation, and diaphoresis which all can be established signs of pain or inadequate analgesia . The objectives of this study are to confirm safety and feasibility of DJ stent insertion under local anesthesia (LA) and to assess the effect of detailed explanation and observing of DJ stent insertion in level of pain experience in male patients, using visual analog scale (VAS) and vital signs changes  before and after the procedure.VAS is a 100 mm horizontal line that can be used to quantify pain in continuous scale of 0 to 10. It is easy to use and requires little written language . This study was conducted at a urology department of a teaching hospital after getting an ethical committee approval.Over a period of six months, from January to July 2012, all males above 18 years old who attended urinary stone disease clinic and have indications for DJ insertion  were included in this study.Exclusion criteria were history of previous cystoscopy, clinical evidence of urethral stricture, psychiatric illness, inability to understand the procedure or the questionnaires, bladder outlet obstruction, stent exchanges, and patient requesting general anaesthesia.All DJ ureteric stents were inserted as temporary measurement while waiting for definitive treatment 4–6 weeks later according to operation room availability.Eighty consenting subjects were randomized by drawing lots to observe or not to observe their DJ stent insertion.They were grouped into group A (those patients who were to view their procedure) and group B .All patients received brief explanation from medical officer about the procedure in outpatient clinic then admitted to hospital as day case.For group A, a video monitor was placed so that both patient and operating urologist could see the procedure. For group B, the monitor was positioned so that only the operating surgeon could visualize the procedure and not the patient. The procedure was performed in urology operating room in lithotomy position by a senior urologist with or without fluoroscopy guidance, where position of DJ stent was checked postoperatively by kidney, ureter, and bladder X-ray (KUB-X-ray).A peripheral venous line was fixed and prophylactic intravenous antibiotic was given.After positioning of the patient and scrubbing with povidone-iodine solution and standard draping, 2% of lidocaine gel was instilled in urethra. DJ stent was inserted in all subjects in standard fashion using 20 F storz rigid cystoscope with 30 degree lens with favorable outcomes and there is no intra- or postoperative complications.Patients' preprocedure pulse rate, systolic and diastolic blood pressure, and procedure time were recorded.Immediately after urologist left the operating room, a medical officer who was blinded to the details of the study collected data on vital signs and asked patients to record their pain experience using a 100 mm unmarked VAS.We categorized the pain as mild, moderate, and severe. No pain was defined as a score 0, mild pain as a score 1–3, moderate pain as a score 4–7, and severe pain as a score 8–10.All patients were informed about the possible infective consequences of the procedure and given ready access to telephone advice or hospital admission if required. t-tests were used to determine the mean differences in the level of pain and both pre- and postprocedure vital sign changes between the two groups. Finally, paired t-tests were used for the assessment of mean differences between pre- and postprocedure vital signs for each group. In this study, a test with P value < 0.05 was considered statistically significant. Descriptive statistics were used to summarize the results. Chi-square test was used to check for a relationship between pain categories and patient group types. Independent P value = 0.000 < 0.05, implying that the pain categories experienced by the patients have an association with the group that they belong to.Using a scale of 0–10, the mean pain (standard deviation) score on VAS was found to be 3.91 ± 3.12. Category-wise, 14 (17.5%) patients did not experience pain during the procedure. On the other hand, 27 (33.8%) of the patients experienced mild pain, 28 (35%) patients experienced moderate pain, and only 11 (13.8%) experienced severe pain. We performed a chi-square test to determine whether there is a relationship between the pain categories and patient group types. The chi-square test produces a t-test to determine whether the mean of pre- and postprocedure vital signs is significantly different for groups A and B. The independent t-test was also done to check for the significant difference in mean age and duration of the procedure. To confirm these findings, we performed an independent P value > 0.05 indicates that the t-test is statistically not significant.We observed from P value < 0.05). These findings confirm that those patients who could view the procedure experience less pain as compared to those who did not view the procedure. The mean pain score experienced by the patients from group B (who could not view the procedures) is almost four times higher than the mean pain score of group A (who did view the procedures).However, the systolic blood pressure after the procedure and the mean pain using VAS are statistically and significant different , and assessed the feasibility of DJ stent insertion under LA as separated topic. To our best knowledge this work has assessed feasibility of DJ stent insertion under LA and tested the effect of detailed explanation and real-time video monitoring of the procedure on pain experience as one subject.Visual analogue scale (VAS) is a valid tool with good responsivity and acceptability; it has been used extensively in the medical literature. Clinically VAS can be used for pain, nausea, fatigue, and sleep quality measurement, with no clinical significant difference between severity of pain being experienced and VAS pain score –27.Our study shows that patients who had the chance to view the procedures experience less pain compared to those who did not.Meanwhile, we believe that those patients of group A, had moderate and severe pain, as further improvement in decreasing the pain of this group might be not possible due to overall minimal anxiety in accordance with Kobayashi et al. findings .Overall, there is an increase in the means of the vital signs after the procedure, but it seems that group B has experienced a more significant increase if compared to group A. In addition there was statistically significant difference in postprocedural systolic blood pressure between groups; however these changes in blood pressure may be from clinical point of view insignificant, as Soomro et al. reported that minor changes in vital signs may be related to other factors besides procedure-related discomfort .DJ stent insertion under local anesthesia is safe and feasible. We recommended self-watching and detailed explanation to patients who underwent DJ stent insertion to reduce the pain and anxiety associated with the procedure.


P < 0.0001) occurrence and amount of intravenous pain treatment than those receiving SA. Patients with SA required less intravenous pain medication and less treatment for nausea/emesis.The leading patient complaint during the perioperative period for penile prosthesis implantation is postoperative pain, while emesis and urticaria also affect the procedure's perceived success. In analyzing surgical outcomes, assessment of the anesthetic for postoperative pain and side effects should be included. This paper retrospectively reviews 90 consecutive, primary inflatable penile prosthetic operations performed by a single surgeon at one private medical center. Fifty-seven patients were included in final analysis. Patients who had more than one procedure that day or who used chronic pain medication were excluded. The type and amount of each drug used for each respective side effect (within the first 24 hours after procedure) were compared to determine relative benefit. Twenty patients received general anesthesia (denoted herein as “GA”) and 37 received spinal  anesthesia (denoted herein as “SA”). Patients receiving GA had significantly greater ( Penile prosthetic surgery has undergone significant changes since its introduction in the 1970's and it is now considered a safe and effective method of treating end organ failure impotence. As established by Pearman, an early leader in research in the field of surgical erectile dysfunction, impotence is defined as the inability to gain or maintain an erection sufficient to sustain satisfactory intercourse due to pathology or deformation of the penis . With inIn the past, postoperative complications of penile prosthetic surgery included, but were not limited to, infection, mechanical failure, device migration, sizing issues, and patient dissatisfaction. As penile prosthesis surgery remains elective, patient satisfaction is of paramount importance. In the immediate postoperative period, patients judge the success or failure of their implant surgery, in part, by the extent of postoperative pain. Prior studies have shown that patients have disparate views of their surgical experience which can be attributed to the type of anesthetic administered –13. In aWe evaluated immediate postoperative pain, urticaria, and nausea/emesis between the two major types of anesthesia currently used. Our hypothesis was that due to the drastic evolution of penile prosthetic surgery, coupled with numerous technical improvements, the necessity for GA should be lessened. We contend that not only have these advancements lessened the necessity for GA they have also lessened the status of GA as the preferable anesthetic. It is our opinion that SA may provide improved analgesia for this short procedure while sparing patients the systemic effects of GA. A retrospective study was conducted by reviewing medical records for 90 consecutive penile prosthetic implantation procedures which were performed by one surgeon at a private institution. There was no standard anesthetic in existence at this center. All patients provided written, informed consent as approved by the local hospital institutional review board.a priori to exclude all cases that included more than one procedure during the operating room time. In addition, age, race, etiology of impotence, and presence of chronic pain medication usage were noted and evaluated. If a patient had been treated for chronic pain with medication, his records were excluded from the study. Data was collected for only the first 24 hours post-procedure as all patients stayed overnight under observation status. All patients had standardized orders for postoperative nursing care for medical treatment of their pain, nausea, and urticaria. The standard order for urticaria was diphenhydramine . For nausea/emesis in the postanesthesia care unit, the order was ondansetron , whereas on the inpatient ward, the standard order was promethazine (25–50 mg). We determined For pain in the after anesthesia care unit, with a visual analog scale (VAS) of 4 or greater on a scale of 0 to 10, the standardized order was for hydromorphone . For the treatment of pain on the inpatient ward, a VAS was used to give oxycodone and morphine as part of the standardized nursing orders.U) test and Fisher's exact test.Data were collected based on each variable for either GA or SA. The side effects observed included urticaria, emesis, and pain. The variables included: operation time, anesthetic time, and the administration of oxycodone, hydromorphone, morphine, promethazine, ondansetron, and diphenhydramine. The medication and dosage used to treat each side effect were recorded in milligrams and the time was recorded in minutes during the postoperative period. Each variable for each type of anesthetic was placed in a spreadsheet and the data were analyzed using Wilcoxon's rank-sum (Mann-Whitney Fifty-seven patients who underwent penile prosthetic implantations were included in the study: 20 surgeries were performed under GA and 37 were performed under SA. There was no significant difference in age (63.1 GA versus 60.8 SA), race, or etiology of impotence (23% diabetic GA versus 31% diabetic SA) between the GA and SA groups.P = 0.2991 and P = 0.9399, resp.).To determine the efficacy of each type of anesthetic, both operative and anesthesia time were measured. The GA mean anesthesia time was 91.7 minutes, with a standard deviation of 15.82 minutes. The SA cohort mean anesthesia time was 85.3 minutes, with a standard deviation of 15.7 minutes. The GA mean operative time was 35.4 minutes with a standard deviation of 7.4 minutes. Finally, the SA population had a mean operative time of 35.9 minutes with a standard deviation of 8.2 minutes. There were no differences between groups for anesthesia time or operative time (P = 0.0489).Comparisons were made as to whether the patient was treated for nausea/emesis and the specific treatment used for it (medication and dose). The two medications evaluated were promethazine and ondansetron (amount in milligrams). Within the GA sample, the mean doses of promethazine and ondansetron administered were 6.25 ± 13.1 mg and 0.2 ± 0.89 mg, respectively. Within the SA sample, the mean doses of promethazine and ondansetron administered were 7.77 ± 9.48 and 0.11 ± 0.66, respectively. There was a significant difference in whether or not the patient was treated for nausea/emesis with promethazine and ondansetron between GA and SA (P = 0.1041). To determine whether or not patients experienced urticaria after SA or GA in penile prosthetic implant procedures, the dose (in milligrams) of diphenhydramine was compared. None of the 20 patients receiving GA were treated for urticaria, whereas 14% of the patients receiving SA were treated for urticaria, with 4.73 ± 12.95 mg of diphenhydramine. These results did not reach statistical significance (P = 0.4805) between anesthesia groups observed for pain which required treatment with oral medications.In evaluating whether GA or SA benefited the patient in terms of postoperative pain, the doses of oxycodone, hydrocodone, morphine, and hydromorphone were compared. Data were analyzed by the number of tablets ingested and/or amount of intravenous medications administered. Hydromorphone was administered in the post-anesthesia care unit and morphine was administered while under observation on the inpatient ward. The dosages of oxycodone and hydrocodone were consistent  and while under observation (morphine) (P = 0.05) on the inpatient ward . The amount of intravenous pain medications administered was compared between GA or SA group with hydromorphone and morphine recorded in milligrams. The GA group required a significantly greater dosage of intravenous treatment for pain, in both the post-anesthesia care unit (hydromorphone) P < 0.000 and whil Figures . AdditioAdding patients to each group would add credence to the study conclusions. Additionally, anesthesia varies among medical institutions. It remains unclear how these results might be affected by anesthesiologist experience in administering spinal and general anesthetic. It should also be noted that these results were taken from a private institution as opposed to a teaching hospital where SA administration can take considerably longer than GA administration. The major complaint of patients undergoing penile prosthesis surgery in the perioperative period is surgical pain . A revieAlthough there was no significant difference in operative or anesthetic time, a difference was discovered regarding need for intravenous pain medications and treatment of nausea/emesis. Of note, the study was done at a private hospital, so the anesthetic time could vary more at an academic setting with students/residents learning SA techniques. The treatment of urticaria trended toward significance, with a greater occurrence with the SA group. While comparing GA and SA in outpatient urological surgery, Erhan et al.  found noThe question of whether regional anesthesia is better than general anesthesia has been debated since the inception of spinal anesthesia at the turn of the 20th century . RegardiOne obstacle in proving our hypothesis is that in most studies addressing the efficacy of SA compared to GA the differences in morbidity and mortality between any anesthetic techniques may be subtle. As a result, very large studies involving a multitude of patients would be required to power a comparison study . A meta-For the benefit of reduced nausea/emesis after GA or SA, our study found a notable difference. Despite advances made in anesthesia, postoperative nausea and vomiting remains a dreaded anesthetic concern . Antieme A publication from Segovia, Spain, revealed significant reduction in intra-operative and postoperative nausea and vomiting in patients undergoing Cesarean section who received ondansetron or metoclopramide as compared with placebo . AnotherConcerning urticaria, though insignificant, there was a trend toward a significant result demonstrating that SA recipients were more likely to experience urticaria. Although severe allergic reactions to medications in any setting are rare, certain patients do have increased sensitivity to injected agents. The importance of a thorough patient history is paramount whenever administering anesthesia. For patients with prior anaphylactic reactions to anesthetic agents, skin prick testing is available and may be used to identify agents responsible for the reaction in an effort to prevent peri-operative anaphylaxis and urticaria .For postoperative pain control, there was a significantly lower requirement for IV pain medications among SA group patients yet there was no significant difference between SA and GA with respect to the administration of oral pain medications. Other studies have also shown that SA can result in less postoperative pain as compared with GA. A pilot study in urological practice was done by Salonia et al., evaluating postoperative outcomes among patients undergoing radical retropubic prostatectomy. In this study, patients with clinically localized prostate cancer were randomized into either a GA or SA group. SA resulted in decreased postoperative pain and faster postoperative recovery and proved to be a safe and effective alternative to GA in this study . In a reThis study is limited by small sample size and inconsistent anesthesia protocols. In addition, the study is limited in that the time spent in PACU was not standardized and that these results may not translate to outpatient (same day surgery) results. In the author's practice, SA is preferred for overnight observation but is not practical for outpatient (same day surgery) recovery time. The administration of spinal anesthetics, and to a lesser extent general anesthesia, may vary from case to case. Future research should include a prospective, randomized study in which the variables for each type of anesthetic can be controlled. Ideally, we envisage the possibility of a standard general anesthesia protocol for each patient. There might also be a standard protocol for SA to determine whether Duramorph had been administered intravenously or in the subarachnoid space in conjunction with the local anesthetic. Additionally, when comparing side effects experienced after surgery, notation should include what anti-emetic medications may have been administered intraoperatively. The variables in our retrospective study varied with each type of anesthetic and between each patient receiving the different types of anesthetics. Based upon our analysis, there is no significant difference between GA and SA in terms of operative time, anesthetic time, and oral pain medications among the patients who received penile implantations. However, with spinal anesthesia, the patients presented with more urticaria. Conversely, greater amounts of intravenous pain medications and treatment of nausea/emesis medication were necessitated by general anesthesia use.


Pain Exposure Physical Therapy is a new treatment option for patients with Complex Regional Pain Syndrome type 1. It has been evaluated in retrospective as well as in prospective studies and proven to be safe and possibly effective. This indicates that Pain Exposure Physical Therapy is now ready for clinical evaluation. The results of an earlier performed pilot study with an n = 1 design, in which 20 patients with Complex Regional Pain Syndrome type 1 were treated with Pain Exposure Physical Therapy, were used for the design and power calculation of the present study.After completion and evaluation of this phase III study, a multi-centre implementation study will be conducted.The aim of this study is to determine whether Pain Exposure Physical Therapy can improve functional outcomes in patients with Complex Regional Pain Syndrome type 1.This study is designed as a single-blinded, randomized clinical trial. 62 patients will be randomized with a follow-up of 9 months to demonstrate the expected treatment effect. Complex Regional Pain Syndrome type 1 is diagnosed in accordance with the Bruehl/International Association for the Study of Pain criteria. Conventional therapy in accordance with the Dutch guideline will be compared with Pain Exposure Physical Therapy. Primary outcome measure is the Impairment level SumScore, restricted version.This is the first randomized controlled study with single blinding that has ever been planned in patients with Complex Regional Pain Syndrome type 1 and does not focus on a single aspect of the pain syndrome but compares treatment strategies based on completely different pathophysiological and cognitive theories.Clinical trials NCT00817128; National Trial Register NTR2090 Complex Regional Pain Syndrome type 1 (CRPS-1) or reflex sympathetic dystrophy (RSD) is a chronic progressive condition of an extremity characterized by a variety of autonomic, sensory, motor and vasomotor symptoms, usually following injury.It describes a variety of painful conditions following injury which appears regionally having a distal predominance of abnormal findings, exceeding in both magnitude and duration the expected clinical course of the inciting event .It often results in impairments of neuromusculoskeletal and movement-related functions, sensory functions and pain, activity limitations and participation restrictions. It shows a variable progression in the course of time.Clinical evaluation and diagnosis of CRPS-1 are based on clinical assessment of signs and symptoms, in accordance with predetermined sets of diagnostic criteria [Conventional therapy, consisting of pharmacological pain management and pain avoidance in functional management, has shown disappointing results in pain control and disabilities, and often leads to inactivity and social disintegration. Considerable impairments are still present over eight years after first CRPS-1 diagnosis .Pain Exposure Physical Therapy (PEPT) is a new and promising therapeutic approach ,4. No prThe CRPS outpatient department of the Radboud University Nijmegen Medical Centre has a long history regarding treatment and research on CRPS-1 -7.The incidence of CRPS-1 in the Netherlands is estimated at around 26.2:100,000 person years and females are 3.4 times more effected than males . About 2A vast proportion of CRPS-1 patients needs major adaptations of their homes to be able to function with their activity limitations and participation restrictions.Current conventional therapy for CRPS-1 has been consolidated in the Dutch national clinical guideline of 2006 . It is fPharmacological treatment consists of analgesics in a step-up procedure in accordance with the WHO’s pain ladder. Dimethylsulphoxide 50% ointment (DMSO) is prescribed as radical scavenger for initial treatment. In cases presenting with allodynia or hyperalgesia, gabapentine, amitryptilin or carbamazepine may be indicated. Dystonia, myoclonia and muscle spasms may be treated with baclofen, diazepam or clonazepam. Vasodilating drugs like verapamil, ketensin and pentoxiphyllin can be prescribed for patients presenting with cold skin. In persistent cold CRPS-1, thoracic sympathectomy can be considered as a treatment option .PEPT is a functional form of physical therapy and consists of a progressive-loading exercise program and management of pain-avoidance behaviour without the use of specific CRPS-1 medication or analgesics. It is based on the assumption that behavioural and psychological factors can exacerbate pain and dysfunction and might help maintain the condition. Patients denominate clear treatment goals in the domains of activities and participation.PEPT aims to decrease kinesiophobia, pain behaviour and learned non-use , and incThe treatment consists of progressive-loading exercises and desensitization beyond the patients’ pain limits. To decrease the enhanced skin sensitivity for touch and pressure, desensitization is carried out using self-massage and forced use of the affected arm or leg in daily activities. The progressive-loading exercises are tailored and focused on specific body functions using standard techniques in regular physical therapy, including passive and active exercises to mobilize joints and muscle stretching. During progressive loading, the physical therapists act mainly as instructors, rewarding functional progression and providing schedules for exercises and activities at home. Complaining about pain is discouraged and it is no longer a subject of debate or a reason to reduce the treatment intensity. Partly due to a limited number of five sessions, PEPT is a very low-cost approach from micro- as well as macro-economic point of view.The pathophysiology of CRPS-1 is not well understood. Most of the studies that have been carried out are observational in nature, with small numbers of patients taking part and, in most cases, without a control group. The conclusions of the studies are not always direct observations, but tend to be interpretations of the observations made by the investigators. A distinction can be drawn between peripheral afferent, efferent and central mechanisms involved in the onset and continuance of CRPS-1. So far, no clear explanation has been found of how these various mechanisms are related to one another. Since no randomized controlled trial have been published yet to validate the different treatment strategies in patients with CRPS-1, the rationale for a specific treatment is considered to be sufficiently convincing to perform individual treatments in patients.It seems that a number of peripheral afferent mechanisms may be involved in the pathophysiology of CRPS-1. Indications point to an inflammatory process, a neuroinflammatory process and tissue hypoxia. Anatomical changes have also been seen in CRPS-1 patients. If a (neuro)inflammatory process is involved, then immunological predisposition may be relevant. There are indications that immunological acquired and/or genetic susceptibility may be involved in the onset of CRPS-1 .(Neuro) inflammation: Disorders in high energy phosphate metabolism in CRPS-1 patients , vasculaArguments supporting the theory that neurogenic inflammation may play a role in triggering CRPS-1 are higher concentrations of bradykinin, neuropeptide Y, Calcitonin Gene-Related Peptide (CGRP) and vasoactive intestinal peptide in patients with CRPS-1  and protTissue hypoxia: Some research findings point to tissue hypoxia in CRPS-1. Patients with the condition are more hyperalgesic to fluids of low pH than control subjects. This applies not only to the skin but also to the deeper somatic structures . PatientAutonomic and motor dysfunctions: Autonomous symptoms are seen in 98% of CRPS-1 patients, but often change as the condition progresses . Autonom Peripheral and central sensitization is a common feature in CRPS-1 as in other neuropathic pain syndromes . VariousNot only the complex patterns of autonomic dysfunction, but also motor and sensory symptoms imply CNS alterations. Typically, active range of movement is restricted, whereas passive movement is often possible. Plastic CNS alterations might explain the complex sensory symptoms . Central changes show both shifts in sensory and motor cortex representation of the limbs in CRPS-1. This altered reorganisation seems to be associated with a pain perception as in phantom limb pain. Therefore, a lack of cortical re-reorganization could be an important factor for long term pain ,29. PatiBehavioural and psychological factors can exacerbate the pain and dysfunction in CRPS-1 and could help maintain the condition in some patients. Effective management of CRPS-1 requires that these aspects be addressed as part of an integrated treatment approach .Scientific argumentation for the physical therapy approach of CRPS-1 reveals a RCT with high level quality  indicatiAnalgesics are often used in clinical practice when treating patients with CRPS-1, and their use is described in various treatment protocols and guidelines -34. The Dimethylsulphoxide 50% ointment (DMSO) has a much greater beneficial impact on CRPS-1 symptoms than placebo according to several studies ,41. N-acThe anticonvulsant gabapentin causes a modest but significant reduction in neuropathic pain symptoms in CRPS-1 patients some weeks after the start of treatment ,43.No randomized control studies have been carried out on orally administered muscle relaxants to treat the motor symptoms of CRPS-1 . BenzodiIntrathecal baclofen therapy (ITB) is an invasive therapy and should be limited to carefully selected patients and, because of a high complication rate, should be conducted only by physicians with considerable experience in the implantation and care of intrathecal devices ,46.Muizelaar et al. investigated the effect of calcium-channel blockers in treating CRPS-1 . They reSympathetic nerve blockade is an accepted treatment option for CRPS-1 patients; for the upper limb blockage of the stellate ganglion or the thoracic sympathetic nerves, for the lower limb the lumbar sympathetic nerves, conventionally carried out at L2 and L3. However, no randomized studies have been carried out on CRPS-1 patients comparing the effect of sympathetic blockades performed under local anaesthetics with valid controls.Regarding intensive physical therapy, including more aggressive or painful exercises , we found three retrospective analyses in children with CRPS indicating that in up to 92% of the included children, a complete recovery of symptoms occurred after intensive physical therapy -50. WatsPain Exposure Physical Therapy has been evaluated in a large case series of 106 patients with chronic CRPS-1 . Ninety-We conducted a n = 1 study on 20 patients with acute CRPS-1 to evaluate the safety of this approach in acute CRPS-1 . None ofThe aim of this study is to determine whether Pain Exposure Physical Therapy (PEPT) can improve functional outcomes in patients with CRPS-1.This study is designed in accordance with the principles of a single-blinded, randomized clinical trial. After randomization to one of the two study groups, according to a pre-fixed scheme, baseline measurements (T0) are performed. Further measurements are taken during the course of the treatment at three months (T1) and at the end of the treatment at six months (T2). Follow up is at nine months (T3) after inclusion. Patients will undergo complete assessments at all time points.Investigators performing the measurements will be blinded for the treatment group. Patients will be carefully instructed not to violate this blinding protocol.http://www.clinicaltrials.gov with number NCT00817128 and at http://www.trialregister.nl with number NTR 2090.This study is approved by the state regional ethical committee and is registered at All patients will be screened, randomized and treated in our university hospital, a level 1 trauma centre in a rural area of The Netherlands. Approximately 150 patients with suspected CRPS-1 are referred to our multidisciplinary outpatient department annually.Hospitals and general practitioners in the region of our hospital will participate in recruitment of eligible patients. The diagnosis CRPS-1 has to be confirmed by Bruehl/IASP criteria (see below) and screening for eligibility is between three and twenty-four months after initial injury. This screening will take place at the outpatient department of the Radboud University Nijmegen Medical Centre. All patients, between 18 and 80 years old, with CRPS-1 of the upper or lower extremity will then undergo eligibility assessment.All patients with possible underlying diagnoses which may cause the pain syndrome will be excluded. Impairments of the contra-lateral extremity, relapse of CRPS-1, pregnancy, lactation and prior sympathectomy of the affected extremity are criteria for exclusion.All patients have to give written informed consent prior to participation in this study. An information letter will be provided, depending on the treatment group.1. Continuing pain, disproportionate to any inciting event2. At least one symptom in each of the four following categoriesa.Sensory: reports of hyperesthesiab.Vasomotor: reports of temperature asymmetry and/or skin colour changes and/or skin colour asymmetryc.Sudomotor/oedema: reports of oedema and/or sweating changes and/or sweating asymmetryd.Motor/trophic: reports of decreased range of motion and/or motor dysfunction  and/or trophic changes 3. At least one sign in two or more of the following categoriesa.Sensory: evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch)b.Vasomotor: evidence of temperature asymmetry and/or skin colour changes and/or skin colour asymmetryc.Sudomotor/oedema: evidence of oedema and/or sweating changes and/or sweating asymmetryd.Motor/trophic: evidence of decreased range of motion and/or motor dysfunction  and/or trophic changes 4. The presence of an initiating noxious event, or a cause of immobilization5. Symptoms cannot be explained by other diagnosesThe sample size calculation is based on the following finding and expectation. The improvement in the Impairment level SumScore (ISS), restricted version ,52, whicThe conventional treatment of CRPS-1, based on the recent Dutch guideline , includeThe experimental treatment is PEPT, a functional form of physical therapy combined with a cognitive-behavioural form of treatment. It consists of a maximum of five sessions of each 40 min. Analgesics are contra-indicated, the experienced pain will not be treated.Diagnosis and treatment of CRPS-1 is performed by the multidisciplinary CRPS outpatient team, including a surgeon, a rehabilitation physician, a physical therapist, an anaesthesiologist and a research nurse. Around 150 new adult patients are visiting this outpatient clinic each year of which 23% is diagnosed having CRPS-1 (confirmed by Bruehl/IASP criteria) between 3 and 24 months after initial injury and without underlying diagnoses which may be responsible for the pain syndrome . This mePatients will be screened and randomized from January 2009 until June 2011. A mean of 4 patients are planned to enrol each month once the study reaches full adhesion. After complete follow-up, it will be finished in the spring of 2012. The final report after data analysis will be expected at the end of 2012.Patients will be pre-screened, based on the referral letter sent by the county hospital or general practitioner, during a multi-disciplinary session of our team. In cases of potentially positive CRPS-1 in accordance with Bruehl/IASP criteria, these patients are invited to undergo thorough screening and multidisciplinary assessment by the same team. Patients with manifest CRPS-1 in accordance with the research diagnostic criteria of Bruehl/IASP, judged unanimously by the team, are asked to participate in the study. They are informed about the study by the research nurse and if they are interested, one week of consideration is scheduled. During this week, an accelerometer  is mounted on the affected wrist (CRPS-1 in the upper extremity) or affected ankle (CRPS-1 in the lower extremity) to measure the intensity of activity in T0. After this one week of consideration, a custom made computed randomization program is used to blindly allocate patients to one of the two treatment groups. The randomization program is made by an investigator with no clinical involvement in the trial.Every patient who will be screened will specifically be informed about the possibility to change treatment group at any time after randomization, but preferably after having finished the initial allocated treatment. Once the computer randomization has been completed, patients who are allocated to the conventional care group are scheduled for their first treatment visit at the outpatient department of anaesthesiology within two weeks. Patients who are allocated to the PEPT group are scheduled for their first treatment at the outpatient department of rehabilitation within two weeks.Each randomization package contains the following forms:· Patient identification tabs· Checklist hospital contacts· Outpatient chart· All written correspondence· Travel compensation forms· Randomization form· Informed consent· Measurement sets (mentioned under “outcome parameters”) for all measure moments· Diaries  for all measure moments· Cost lists  for all measure moments· Questionnaires (mentioned under “outcome parameters”) for all measure moments· PAM scoring list· PAM result listAll measurements taken in both treatment groups during the course of this study are carried out by an experienced research nurse who underwent extensive measurement instructions, training and supervision before she was considered qualified to perform all measurements. She is blinded for the treatment group in all patients. In order to maintain this blindness, we thoroughly instruct all patients not to violate her blindness. To further guarantee her blindness, we instruct her to put a small amount of menthol ointment on her upper lip during each measurement session. This prevents her from smelling the garlic odour of DMSO ointment, which is part of the conventional treatment.The primary outcome measure is the Impairment level SumScore (ISS), restricted version ,52. The 1. The Disability of the Arm, Shoulder and Hand (DASH), a questionnaire which maps both functions and daily activities of the upper limb ,59. The 2. The fear-avoidance beliefs questionnaire (FABQ) , a state3. The level of participation as determined by the questionnaire SF-36 , which m4. At function level, the muscle force measurements, as derived from both hands and feet by a handheld dynamometer (MicroFET) ,64.5. At level of activity limitations, for the legs the 10 m walking test   ; this is8. Adverse reactions will be monitored throughout the trial using standardized Serious Adverse Event forms, specifically regarding exacerbations of CRPS-1 signs and symptoms leading to medical consultation.This study investigates the potential efficiency of PEPT versus conventional treatment in patients with CRPS-1 from a societal perspective. The economic evaluation is based on the general principles of a cost-effectiveness analysis. Primary outcome measures for the economic evaluation are costs and quality adjusted life years (QALYs). The ratio cost per QALY gained  will be computed and uncertainty will be determined using the bootstrap method or Fieller method. Finally, a cost-effectiveness acceptability curve will be derived that is able to evaluate efficiency by using different thresholds  for a QALY. The impact of uncertainty surrounding deterministic parameters (for example cost-prices) on the ICER will be explored using one-way sensitivity analyses on the range of extremes. The economic evaluation is being done alongside the clinical trial and consequently adheres to the earlier presented design and measurement points.The effect analysis adheres to the design of a randomized controlled trial, relevant for the economic evaluation quality of life. Quality adjusted life years (QALYs) will be computed (using the trapezium rule) in order to perform a cost-utility analysis for the two alternative strategies. For the overall quantification of health status as a single index (utilities) we use the standard EQ-5D classification system developed by the EuroQol Group. The EQ-5D is one of the three widely used multi-attribute systems available to determine health states preferences (utilities). We chose the EQ-5D because 1) the five domains of the EQ-5D reflect aspects that are thought to be important for the population under consideration, 2) the system is relatively simple to administer, 3) the sensitivity of the instrument proved to be satisfactory, and 4) a reasonable sound algorithm has been published to compute utilities.The cost analysis exists of two main parts. First, on patient level, volumes of care will be measured prospectively using standardized Case Report Forms (CRF) and patient-based diaries. Per treatment group, full cost-prices will be determined using activity based costing. Activities in both production processes are outpatient visits and physical therapy. Medication costs constitute of analgesics, DMSO 50%, n-acetylcysteine, gabapentine, carbamazepine, amitriptylin, nortriptylin, baclofen, diazepam, clonazepam and sympathetic blocks. Productivity losses for patients will be estimated using an interview on a 2 months recall basis by the researcher. The frictioncost-method will be applied. Also travel time to therapy or outpatient clinic and related costs will be considered, on the basis of 2 months recall.The second part of the cost analysis consists of determining the cost prices for each volume of consumption in order to use these for multiplying the volumes registered for each participating patient. The Dutch guidelines for cost analyses will be used . For uniThe potential effects on medical costs are expected to be approximately €2802,75 per treatment in conventional care and around €1008,50 per treatment in PEPT. Costs based on social participation and work are not included in these prices  in effect between groups between T0 (intake) and T3 (follow-up) for the primary outcomes.For the secondary outcomes, even as for cost differences, explorative tests will be used (Wilcoxon). Two analyses will be performed: an intention-to-treat analysis (ITT) and a per-protocol analysis (PP). In the ITT analysis, outcomes of all the participants will be used for the group they are originally assigned to. In the PP analysis, outcomes of protocol violators will be ignored.Clinical trials on the treatment of patients with CRPS-1 are scarce due to deficiency and controversy in objective diagnostic criteria and underlying pathophysiology. Most clinicians support an approach of multiple interventions at different dimensions, customized to the individual patient. Therefore, only few patients can be identified with a homogenous clinical presentation for whom a therapeutic approach can be standardized. Intervention trials in patients with CRPS-1 have therefore typically been focused on a single item of this approach. This makes the results of individual trials difficult to interpret and the comparison of multiple trials impossible. One of the most important efforts to improve the level of evidence for treatments in this field is to equalize diagnostic criteria. At present, the Bruehl/IASP criteria are the international standard to diagnose a patient with suspected CRPS-1, not only for research applications but also in clinical practice. In our outpatient department for CRPS-1 patients, we use these criteria without restraints ever since 2004. Clinical studies from The Netherlands have been highly respected internationally due to the large amounts of patients that are treated in our country. It has to be confirmed that the diagnostic criteria according to Veldman, which have been used nationwide, are no longer valid. More than 75% of patients who are referred with positive Veldman criteria do not have CRPS-1 according to the Bruehl/IASP criteria .Due to the evolvement in diagnosing CRPS-1, it is possible to recruit a homogenous patient group, which is eligible for solid prognostic studies such as the current one.The new and promising approach in the treatment of CRPS-1, PEPT, has proven to be safe and possibly effective, and is now ready for clinical evaluation.This is the first randomized controlled study with single blinding that has ever been planned in patients with CRPS-1 and does not focus on one single item but compares treatment strategies based on completely different pathophysiological and cognitive theories.CRPS-1: Complex Regional Pain Syndrome type 1; PEPT: Pain Exposure Physical Therapy; IASP: International Association for the Study of Pain; WHO: World Health Organization; DMSO: Dimethylsulphoxide 50% ointment; CNS: Central nervous system; fMRI: Functional Magnetic Resonance Imaging; ISS: Impairment level SumScore; PAM: Physical activity monitor; QALY: Quality adjusted life year.Financial competing interests.The authors declare that they have no financial competing interests.Non-financial competing interests.The authors declare that they have no non-financial competing interests.KB largely rewrote the manuscript after critically revising it, and finished the manuscript. RO contributed substantially to conception and design and by revising it critically for important intellectual content. RvD assisted in study design and drafted the parts on conventional therapy. FK assisted in study design and drafted the parts on the experimental treatments. HS assisted in study design and drafted the parts on secondary outcome parameters. GJvdW assisted in study design and drafted the parts on power calculation and randomization. EA assisted in study design and drafted the parts on economical and cost analysis. HG drafted the parts on statistical analysis. HvdM conceived of the study, and participated in its design and coordination and helped to draft the manuscript. JPF originally drafted the manuscript in accordance with the awarded research grant from the Dutch Government (ZonMw). All authors read and approved the final manuscript.KB is currently a medical student at the Radboud University Nijmegen.RO started his education in physical therapy (PT) at the Sint Maartenskliniek, Nijmegen, The Netherlands in 1963. He received his bachelor degree PT in 1966 and his degree in Manual Physical therapy (MPT) in 1972. He studied rehabilitation sciences (MSc) at the Free University of Brussels, Belgium which he finished in 1984 cum laude. Between 1984–1988 he did his PhD at the Radboud University Nijmegen, The Netherlands. Between 1968–1982 he was head of the department of physical therapy in general hospitals and teacher at the School of Physical Therapy ‘West Brabant’, Breda, The Netherlands. Between 1988–2007, he became research director of the Dutch Institute of Allied health Care, Amersfoort, The Netherlands. Between 1989–2000 he was full professor Manual Therapy at the Free university of Brussels, Belgium. From 2000 until his retirement in 2008, he was full professor in Allied Health Sciences at the Radboud University Nijmegen, The Netherlands, with a focus on the quality of allied health care and development, implementation and evaluation of clinical guidelines. He has a long-standing practical experience with regards to treatment of patients with Complex Regional Pain Syndrome (CRPS). He has published about 250 articles in national and international journals. He is member of various national and international physical therapy organizations and reviewer of national and international journals.RvD is anaesthesiologist at the Pain Centre of the Radboud University Nijmegen Medical Centre, The Netherlands since 1988. He participates in all activities in an Academic Multidisciplinary Pain Centre for acute pain, chronic pain, pain in cancer and palliative care. Specific expertise in invasive pain treatment, neuromodulation for pain relief. He is Chairman of the Dutch Society for Neuromodulation and former Chairman of Pain Section of the Dutch Society for Anaesthesiology.FK is working as a physical therapist since 33 years in his own practice and at the Department of Physical Therapy of the Radboud University Nijmegen Medical Centre. Specific expertise in treatment of patients with chronic pain and Complex Regional Pain Syndrome (CRPS). He is also working as a Quality of Care employee at the Department of Physical Therapy.HS has been working as a clinical psychologist in pain medicine since 1990 and is working at the Academic Centre of Pain and Palliative Care of the Radboud University Nijmegen Medical Centre. He successfully finished his PhD thesis in 2008, titled Psychological factors in chronic pain: from predictors to implementation. In 2002 he wrote a book titled The psychologist as pain specialist. He is specialized in diagnosing and treating chronic pain within tailored treatment designs and in translating scientific knowledge into clinical practice for doctors, psychologists, physical therapists and nurses.GJvdW is professor of Health Technology Assessment at the Radboud University Nijmegen Medical Centre and professor of Interactive Health Technology Assessment at the Athena Institute, Free University Medical Centre, Amsterdam. He is a member of the Standing Committee on Medical Technology Assessment of the Health Council of The Netherlands and member of the National Appraisal Committee at the National Health Insurance Board. He serves on the Editorial Board of the International Journal of Technology Assessment in Health Care and is a member of the International Network of Agencies for Health Technology Assessment (INAHTA).EA studied graduated as an economist in 1990. Then a professional career was started as a university lecturer at Maastricht University, faculty of Economics. In 1997, he successfully finished his PhD thesis . Earlier, in 1996, he started as an assistant professor at the department of Health, Organization, Policy, and Economics (BEOZ) of the faculty of Health Sciences, Maastricht University. In the beginning of 2001 he started as a senior consultant at the Ministry of Economic Affairs in The Hague, which he left late 2001 for an assistant professorship at the Radboud University Nijmegen Medical Centre. Here, he joined the department of Medical Technology Assessment of which he became deputy head in 2004. Presently the department is merged into the department of Epidemiology, Biostatistics and HTA. Several publications about economical aspects of health care are from his hand.HG studied Biology and Biophysics at the Radboud University Nijmegen . In 1986, after additional training in information technology, he joined the department of Epidemiology as a scientific programmer. He specialized in methodological and statistical support of several PhD projects. He also lectured in statistical methods for Biomedical students. From 2005 on, he specialized in Health Technology Assessment. Nowadays, he participates in several research projects of major departments at the Radboud University Nijmegen Medical Centre as a methodological and statistical consultant.HvdM is consultant at the Department of Rehabilitation Medicine at the Radboud University Nijmegen Medical Centre, The Netherlands. He worked at the department of neurosurgery Erasmus UMC Rotterdam and AMC Amsterdam, both in The Netherlands. He worked as post-doc at the Institute for Brainresearch Zurich, Switzerland and as house officer neurology both at the University Clinic Balgrist Zurich, Switzerland and at the NRZ Greifswald in Germany. He was trained as rehabilitation physician at the Sint Maartenskliniek in Nijmegen, The Netherlands. Since 2003, he is associate professor at the Department of Rehabilitation Medicine at the Radboud University Nijmegen Medical Centre, The Netherlands with specialization in care, research and education in management of spasticity in children with cerebral palsy, acute management and rehabilitation of spinal cord injury, development of innovative orthotics and prosthesis for trauma and orthopaedic rehabilitation, early intensive physical and cognitive rehabilitation of patients with critical illness with application of virtual reality devices (X-VR-D) and experimental management and rehabilitation of patients with CRPS-1. He cooperates in the multidisciplinary outpatient department for patients with CRPS since 2004.JPF is consultant  trauma surgeon at the Department of Surgery from the Radboud University Nijmegen Medical Centre in The Netherlands. He graduated from The University of Utrecht Medical School, The Netherlands in 1990 with a specialization in General Surgery in 1996 and a subspecialization in Trauma Surgery in 2001 at the Free University Medical Centre in Amsterdam, The Netherlands. In the same year he defended his thesis successfully. In 2009, he graduated in clinical epidemiology at the Radboud University Nijmegen, The Netherlands. In 2004, he adopted the outpatient department for CRPS patients from his famous predecessor professor dr. RJA Goris, who retired at that time.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/13/58/prepub


Burn pain is recognized as being maximal during therapeutic procedures, and wound debridement can be more painful than the burn injury itself. Uncontrolled acute burn pain increases the stress response and the incidence of chronic pain and associated depression. Although opiates are excellent analgesics, they do not effectively prevent central sensitization to pain. The anticonvulsant gabapentin has been proven effective for treating neuropathic pain in large placebo-controlled clinical trials. Experimental and clinical studies have demonstrated antihyperalgesic effects in models with central neuronal sensitization. It has been suggested that central neuronal sensitization may play an important role in postoperative pain.The aim of this study was to investigate the effect of gabapentin on morphine consumption and postoperative pain in burn patients undergoing resection of burn wounds.In a randomized, double-blind, placebo-controlled study, 50 burn patients received a single oral dose of gabapentin (1200mg) or placebo 2h before surgery. Anesthesia was induced with propofol and fentanyl and maintained by infusingpropofol, remifentanil, and 50% N2O in O2. All patients received patient-controlled analgesia with morphine at doses of 2.5 mg bolus and a lock-out time of 10 min for 24h before the operation. Pain was assessed on a visual analog scale (VAS) at rest and during movement at 1,4,8,12,16,20, and 24 h before the operation. Heart rate, oxygen saturation, mean arterial blood pressure, respiratory rate, sedation score, and morphine consumption were studied.All the enrolled patients were able to complete the study; therefore, data from 50 patients wereanalyzed. The VAS scores at rest andduring movement at 1,4,8,12,16,20, and 24 h after the operation were significantly lower in the gabapentin group than in the placebo group (P < 0.05). Morphine consumption was significantly lessr in the gabapentin group than in the placebo group (P < 0.05). Sedation scores were similar in the 2 groups at all measured times. There were no differences in adverse effects between the groups.A single oral dose of 1200mg gabapentin resulted in a substantial reduction in postoperative morphine consumption and pain scores after surgical debridement in burn patients. Anesthesia was induced with 2mg/kg propofol, 3µg/kg fentanyl, and 0.5 mg/kg atracurium. After endotracheal intubation, anesthesia was maintained with propofol infusion at a rate of 50 to 150 µg/kg/min with a fixed infusion of 0.4 µg/kg/min remifentanil, and 50% N2O in O2. The infusion of propofol and remifentanil was continued until the debridement of the burn wound was completed. Neuromuscular blockade was then reversed with IVadministration of 0.04 mg/kg neostigmine and 0.02 mg/kg atropine. After tracheal extubation, patients were transferred to the postanesthesia care unit (PACU). Postoperative analgesia was provided with IV-PCA morphine (2.5 mg bolus and 10 min lock-out time)upon arrival in the PACU. An additional 2.5 mg of morphine was administered intravenously by a nurse observer, if requested by the patient during the lock-out period. During the first 1h in the PACU, and then at 4, 8, 12, 16, 20, and 24 hours after extubation, patients were evaluated for pain scores (VAS) at rest and during mobilization from the supine to the sitting position. total dose of morphine consumption, heart rate (HR), SpO2,mean arterial pressure (MAP), respiratory rate (RR), and sedation score were also evaluated by an anesthesiology resident not otherwise involved in the study. The occurrence of any side effects, such as nausea, vomiting, constipation, respiratory depression, dizziness, somnolence, diarrhea, headache, and pruritus, was recorded. Morphine was stopped if the patient had a RR < 10 breaths/min, SpO2< 94% by pulse oximetry, or a serious adverse event related to opioid administration. Ondansetron (4mg) was intravenously administered for nausea and vomiting upon patient request. No other medications were administered during the 24-h observation period. A sample size of 25 patients per group was calculated to detect a significant difference of 15% or more in morphine consumption with a power of 85% and a significance level of 5%. Descriptive statistics are expressed as mean ± standard deviation (SD) unless otherwise stated. Normality of distribution was tested by the Kolmogorov–Smirnovtest. Student’s t-test was used for comparing the means of continuous variables and normally distributed data. The Mann–Whitney U-test was used in other cases. Two-way analysis of variance was used to compare groups, and Bonferroni correction and Tukey’s honestly significant difference (HSD) test were used for multiple comparisons. Categorical data were analyzed using eitherthe χ² testor Fisher’s exact test, as appropriate. Significance was determined at P < 0.05.After obtaining approval from the hospital ethical committee and obtaining written informed consent from all participants, 50 patients undergoing surgical debridement of burn wounds were enrolled in the study. Inclusion criteria were as follows: patients had to have an American Society of Anesthesiologists (ASA) physical status classification of I or II , had to be of age between 20 and 60 years, and had to have 10–35% total body surface area (TBSA) burns in the lower limbs. Patients were not included if they could not operate a PCA device, were breast feeding, had an allergy to gabapentin or morphine, or had a history of alcohol or drug abuse, chronic pain, daily intake of analgesics or anticonvulsants, antidepressant use, diabetes, or impaired kidney function. The study was conducted using a double-blind randomized controlled design, and all the operations were performed by the same surgeon. All patients were informed, during the pre-anesthetic examination, aboutthe use of the PCA device and the visual analog scale (VAS), in which 0 (zero) mm represented no pain and 100mm represented the worst pain imaginable. Patients were randomized, using a closed-envelope system, to receive either 1200 mg oral gabapentin (n=25) or placebo (n=25) 2 h before surgery. In the placebo group, patients were given placebo pills that were identical in appearance to gabapentin. Although the study drug (s) was given by a nurse, the investigators remained blinded to the group assignment. Upon arrival to the operating room, all patients were premedicated with 0.04 mg/kg of intravenous (IV) midazolam. Electrocardiographic electrodes and a non-invasive blood pressure monitor were applied and oxygen saturation (SpOTable 1). MAP, HR, SpO2, and respiratory rate were not different between the groups at any of the measured times (Table 2). Patients in the placebo group experienced more pain than the patients in the gabapentin group in both the lying and moving positions (P < 0.05) during the 24-h period after the debridement procedure (Table 3). Sedation scores were similar at all measured times in the gabapentin and placebo groups (P > 0.05). Postoperative morphine consumption at 8, 12, 16, 20, and 24h after surgerywas significantly lower in the gabapentin group than in the placebo group (P < 0.05) (Table 4). Total morphine consumption was reduced from 52.45 ± 10.4 mg in the placebo group to 33.8 ± 18mg in the gabapentin group (P < 0.05). The incidence of side effects is shown in Table 5. The most common side effects during the study were nausea and vomiting, but there was no difference in the incidence of side effects between the groups. Two patients in each group vomited, and 8 patients in the gabapentin group and 9 patients in the placebo group received ondansetron (P > 0.05). From June1, 2009 to June 1, 2010, 50 consecutive patients who fulfilled the inclusion criteria were included in the study. All enrolled patients were able to complete the study; therefore, data from 50 patients were analyzed. The groups were comparable with respect to age, body weight, height, ASA physical status, duration of surgery, and burn size (et al. (The main finding of this study was that a single, preoperative dose of 1200 mg gabapentin decreased total postoperative morphine consumption and postoperative pain scores at rest and upon movement after debridement of burn wounds. Moreover, gabapentin was not associated with more side effects than was the placebo. Coderre and Melzack confirmed that burn injuries not only make injured areas and surrounding tissues more painful but also cause hyperalgesia, which is a significant problem for many patients . In burnet al.  were unaet al. -28. We d


Rationale. Poststernotomy pain and impaired breathing are common clinical problems in early postoperative care following heart surgery. Insufficiently treated pain increases the risk of pulmonary complications. High-dose opioids are used for pain management, but they may cause side effects such as respiratory depression. Study Design. We performed a prospective, randomized, controlled, observer-blinded, three-armed clinical trial with 100 patients. Group 1 (n = 33) and Group 2 (n = 34) received one 20 min session of standardized acupuncture treatment with two different sets of acupoints. Group 3 (n = 33) served as standard analgesia control without additional intervention. Results. Primary endpoint analysis revealed a statistically significant analgesic effect for both acupuncture treatments. Group 1 showed a mean percentile pain reduction (PPR) of 18% . Group 2 yielded a mean PPR of 71% . In Group 1, acupuncture resulted in a mean forced vital capacity (FVC) increase of 30 cm3 (SD 73) without statistical significance (P = 0.303). In Group 2, posttreatment FVC showed a significant increase of 306 cm3 . Conclusion. Acupuncture revealed specific analgesic effects after sternotomy. Objective measurement of poststernotomy pain via lung function test was possible. Median sternotomy represents a surgical technique, in which the sternum is longitudinally incised and opened to get access to the organs of the mediastinum, for example, for heart transplantation, to set bypasses or valves on aortocoronary arteries, or to remove thymus tumors. Poststernotomy pain and impaired spontaneous breathing are common clinical problems in early postoperative care following heart surgery , 2. InsuHigh-dose application of opioids represents the standard therapy after sternotomy. It is controversially discussed whether opioids after median sternotomy lead to side effects such as respiratory depression, vomiting, nausea, and sedation , 4. TherThe aim of the present investigation was, therefore, to investigate the effect of needle acupuncture on pain-induced reduction of lung function after median sternotomy. To this end, a prospective, randomized, controlled, patient- and observer-blinded clinical trial was performed with patients undergoing median sternotomy. The study was designed as a prospective, randomized, controlled, patient- and observer-blinded, three-armed clinical trail. Between September 2005 and August 2008, 100 thoracotomized patients were recruited from the intermediate intensive care unit (IMC) in the Department of Heart Surgery at Heidelberg University Hospital. Informed consent was obtained before subject enrollment according to a clinical trial protocol approved by the local Ethical Committee. Patients were included in the study if they had undergone conventional on-bypass surgery via median sternotomy and reported pain during deep inspiration with an intensity of at least 3 on a 1–10 numeric rating scale under standard analgesia with tNSARs and high-dose opioids. Patients had to be extubated and lucid. Patients meeting these criteria were excluded if they had a medical history of severe obstructive or restrictive pulmonary disease. Due to safety reasons, patients with a blood clotting time exceeding 4 min and/or a platelet count below 50.000 nL under anticoagulative therapy were also not accepted to the study. Additional ineligibility factors included acute general infection  and/or local infection at the sites of potential needle insertion. Measures specifically influencing pain perception and/or lung function  were prohibited during the active 40 min study period  and would result in an exclusion from the study. Furthermore, intolerance to acupuncture treatment or sudden worsening of the physical condition would lead to a discontinuation of the study.Subjects were randomized to 3 study groups: Group 1 and 2 received one single 20 min session of standardized verum acupuncture treatment in addition to standard analgesia. Acupuncture was performed on 12 acupoints using sterile 0.25 × 40 mm surgical stainless steel needles. Needles were stimulated by rotation for approximately 5 sec during insertion, after 10 min, and before removal after 20 min. Additionally, in both groups, six of the selected 12 acupoints were treated with “blood-letting” or “leopard spotting technique” using sterile 033 mm 29-gauge needles. To rule out systematic acupuncturist-dependent fluctuations in overall treatment effects, all acupuncture treatments were carried out by the same physician, who had advanced training in traditional Chinese medicine (TCM).The only systematic difference between acupuncture in Group 1 and Group 2 was the acupoint selection. In Group 2, the acupoint selection was based upon common classical Chinese diagnostic features shown by an a priori investigated representative patient collective . A short summary of the acupoint selection is given in the following paragraph. Specific diagnostic technical terms are quoted and described with an auxiliary Western medical explanation in brackets. According to a well-known part of classical Chinese medical theory—the Shang Han Lun—which is systematized in the “Algor Laedens Theory” of the “Heidelberg model of TCM”, severe postoperative pain arises from “xue stasis” (relative hypoxis of a tissue arising from a disrupted microcirculation) due to “post-traumatic algor”  . SP 10 wAcupoint selection in Group 1 served as a verum acupuncture control as it presented a form of inferior acupuncture—acupoints were exclusively selected according to their ascribed therapeutical actions and medical indications propagated by the acupuncture literature. LI 4 was included as a well-known, analgesic acupoint . GV 20 aA detailed list of the selected acupoints is illustrated in Tables Randomization was stratified using consecutively numbered envelopes, containing the details of allocation. The envelopes were filled and sealed prior to study enrolment by an independent assistant according to a password-protected, computer-generated randomisation list. The envelopes were opened in a row by the acupuncturist at the bedside after recruitment. The designated observer and those patients allocated to an intervention arm (Group 1 or 2) were blind to treatment. Patients were informed that the study aimed to compare two different acupuncture treatments with respect to their analgesic effect after sternotomy.Dynamic pain assessment via numeric rating scale to record changes in subjective pain perception was carried out dynamically—during deep inspiration. Two different numeric rating scales were chosen; to semiquantify baseline chest pain, a conventional 1–10 NRS was used. To record the residual chest pain after treatment/observation in relation to the initial pain intensity, a 0%–100% NRS (subdivided into 10% sections) was implemented. The baseline pain intensity served as the individual “100%—reference pain” for this 0%–100% NRS. Measurement of forced vital capacity (FVC) served as a physical and, thus, objective parameter to indicate analgesia-related functional improvements in rib cage expansion.Percentile pain reduction (PPR) after treatment served as primary efficacy parameter, posttreatment change in FVC compared to baseline FVC was chosen as secondary efficacy parameter. For primary and secondary endpoint analyses, the Kruskal-Wallis test was performed as a 3-group global test, followed by the Wilcoxon test for post hoc analysis in case of a significant outcome. Correlation and subgroup analysis was performed to further investigate the a priori assumed pathophysiological connection between chest pain intensity and FVC measurement.Baseline and control efficacy assessment was carried out by a blinded observer and comprised two elements. Out of 367 screened patients, 100 patients met the inclusion criteria and were randomized to one out of three possible study groups. Participant flow through the trial is shown in P < 0.001), and acupuncture treatment in Group 2 yielded a mean PPR of 71% . Primary endpoint analysis revealed a statistically significant analgesic effect for both acupuncture treatments—acupuncture in Group 1 resulted in a mean PPR of 18% , which failed to attain statistical significance . In Group 2, post-treatment FVC showed a statistically significant, average increase of 306 cm3 , with a strong correlation to PPR outcomes (spearman's rank correlation coefficient = 0.74). Pain reduction and FVC changes after acupuncture in Group 1 did not correlate in a statistically significant manner (P = 0.503). In Group 1, acupuncture resulted in a mean FVC increase of 30 cm3) exclusively occurred in patients with a PPR of 60%, or greater  led to functional improvements in lung function. This result further emphasizes the importance of maximal efficacy of postoperative analgesia to prevent pulmonary complications . Some liIt is a long-lasting discussion in the scientific literature that strong postoperative pain and a considerable incidence of chronic pain after cardiac surgery and median sternotomy necessitate effective pain management . A numbeIn the present investigation, we clearly demonstrated that classical needle acupuncture without electrostimulation also led to significant pain reduction and lung function improvement. This may have impact on future concepts of pain management after median sternotomy in heart surgery. The fact that the acupuncture treatment of Groups 1 and 2 differ in their analgesic effects in the present study indicates that it considerably matters which acupoints are used and contradicts the view that acupuncture might only mediate nonspecific skin stimulation, which may or may not exceed placebo effects . As imagP, amongst others [The exact mechanisms for acupuncture-mediated pain reduction in general and after median sternotomy are not well understood as yet. Different modes of action may account for pain reduction such as the release of endogenous opioids , adenosit others –26. In conclusion, the present clinical trial demonstrated that acupuncture revealed specific effects in pain management after median sternotomy. Objective measurement of poststernotomy pain by a lung function test was possible and enabled to distinguish between functionally insignificant pain reduction (resulting in no improvement of breathing) and clinically significant analgesia effects of acupuncture.