INTRODUCTION: Many patients suffer from mild, moderate or severe pain during or after root canal therapy. Theoretically, post-operative pain control can be achieved by using long-acting local anesthetics. The aim of this study was to evaluate the efficacy of a long acting anesthesia, bupivacaine, on preventing post-operative pain associated with endodontic treatment, and to compare it with lidocaine.MATERIALS AND METHODS: This study was a double blind and randomized clinical trial on 30 patients' anterior maxillary teeth. The patients were divided into two groups of fifteen. One group was administered lidocanine (2% with 1:100000 epinephrine) local anesthesia and the other group was given bupivacaine (0.5% without epinephrine). The pain in patients were compared using the visual analogue scale (VAS) at definite times i.e. before treatment, during treatment and 2,4,6,8,10,12,24,36 and 48 hours after operation. Data were analyzed using One-way ANOVA tests.RESULTS: Bupivacaine significantly decreased postoperative pain compared to lidocaine. Postoperative pain was directly related to preoperative pain. Women reported more pain, though significant difference in postoperative pain report was not found between different ages.CONCLUSION: In conclusion, a single dose of bupivacaine 0.5% used in infiltration anesthesia could be more effective in reduction or prevention of post-operative endodontic pain compared with lidocaine. The perceived association of pain with endodontic therapy is a great source of fear for many patients and can prevent them from seeking treatment . ControlAn objective of endodontic therapy is to relieve and/or prevent patient pain. Good anesthetic technique can considerably eliminate pain during treatments; but, post-treatment endodontic pain remains a significant predicament . Post-opA range of local anesthetic drugs have been used in dentistry. Lidocaine, the first commercialized amide local anesthetic, is still the most widely used anesthetic in some countries . It is cetal. found that using bupivacaine in thyroid surgery significantly decreased post-operative pain and the need for analgesic drugs in these patients  to prevent post-operative pain associated with endodontic treatment, and to compare it with lidocaine.The Institutional Ethics Committee of Mashad University of Medical Sciences approved the protocol and the informed consent documents of this study. All patients provided written informed consent before being enrolled. Thirty adult patients (13 women and 17 men), with an age range of 18-61 years participated in this randomized, double-blind clinical trial. They were referred to the Department of Endodontics, Mashad Dental School.Inclusion criteria were healthy persons (ASA I or II), who required endodontic treatment in upper anterior vital teeth with a clinical diagnosis of irreversible pulpitis and no history of root canal therapy. Exclusion criteria included allergy to amide local anesthetics, pregnancy or lactation, any endocrine or infectious disease, moderate to advanced periodontal disease, nonvital teeth (necrosed).Bupivacaine was provided from 20 mL Marcaine vials  and inserted into the lidocaine cartridges that were emptied previously, and the cartridges were coded by a person who was not directly involved in data collection.Each patient rated his or her initial pain on a 10-cm Visual Analogue Scale (VAS) with a range of no pain (0 cm) and unbearable pain (10 cm). These 30 patients were randomly divided into two study groups.i.e. lidocaine 2% was passively placed on the infiltration site for 60 seconds using a cotton-tip applicator. Then the two local anesthetic injections were given by using a standard dental aspirating syringe fitted with a 27-gauge, 1.5 inch needle. One operator performed all of the anesthetic procedures. This operator was not involved in data analysis.Group 1 received 1.8 mL of lidocaine 2% with 1:100.000 epinephrine . Group 2 received 1.8 mL of bupivacaine 0.5% without epinephrine  . TopicalThe target site was centered over the root apex of the maxillary incisors or canines and anesthetic solution was deposited at the rate of 1 mL/min. After administration of local anesthesia and application of rubber dam, access cavity was prepared. The root canals were instrumented using step-back technique and hand files. Sterile saline solution was used as the irrigant. Then all root canals were filled with gutta-percha by lateral condensation technique by one operator.Root canal therapy was carried out identically in one visit for all 30 patients. Patients were instructed to rate any occurring pain during the endodontic procedure using VAS. Treatment was deemed successful if no pain or mild discomfort (VAS score of 0 or 1) was felt during access cavity preparation and instrumentation.A questionnaire was given to the patient at the end of the appointment. Patients were taught how to assess and record the incidence and severity of pain at 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after the appointment.Anesthetic success and the degree of post-operative pain among the two groups were analyzed using One-way analysis of variance (ANOVA). Comparisons were also made to evaluate the relation of pain with the other contributing factors such as sex and age with independent t test. Comparisons were considered significant if P was less than 0.05.All 30 recruited volunteers completed the trial.The results of this study were divided into five reports as outlined below.1- Mean of post-operative pain in bupivacaine and lidocaine groups differed significantly (P<0.05). The mean of post-operative pain in the bupivacaine group was less than the lidocaine group .2- Relation of age and pain without considering the kind of anesthetic drug: patients were divided into two groups; less than 40 years (16 patients) and more than 40 years (14 patients). There was no significant difference between these two groups .3- Relation of pre- and post-operative pain: without considering the kind of anesthetic drug, there was a significant difference between pre- and post-operative pain (P<0.05).4- Relation of gender and the amount of pain without considering the kind of anesthetic drug: post-operative pain in women was significantly greater (P<0.01) .5- Corresponding impression between gender and time: males and females showed differences in the average of pain at different times after treatment. Maximum pain felt in men was four hours post operation and decreased gradually. However, women experienced maximum pain 12 hours after treatment, and this decreased sharply after 12 hours .Reduction of post-operative pain is of para-mount importance for patient and dentist. The aim of this study was to evaluate the use of long acting anesthesia for pain control after RCT.It was hypothesized that long acting anesthetic like bupivacaine would cause effective anesthesia at time of treatment and also would et al.  we can safely conclude that bupivacaine infiltration injections were more successful than lidocaine infiltration for post-endodontic pain control in maxillary anterior teeth.Moreover, the severity of pain after treatment was directly related to the pain before treatment.


Undifferentiated chest pain in the emergency department (ED) is a diagnostic challenge. One approach includes a dedicated chest computed tomography (CT) for pulmonary embolism or dissection followed by a cardiac stress test (TRAD). An alternative strategy is a coronary CT angiogram with concurrent chest CT . The objective of this study was to describe the ED patient course and short-term safety for these evaluation methods.This was a retrospective observational study of adult patients presenting to a large, community ED for acute chest pain who had non-diagnostic electrocardiograms (ECGs) and normal biomarkers. We collected demographics, ED length of stay, hospital costs, and estimated radiation exposures. We evaluated 30-day return visits for major adverse cardiac events.A total of 829 patients underwent TRAD, and 642 patients had TRO. Patients undergoing TRO tended to be younger (mean 52.3 vs 56.5 years) and were more likely to be male (42.4% vs. 30.4%). TRO patients tended to have a shorter ED length of stay (mean 14.45 vs. 21.86 hours), to incur less cost (median $449.83 vs. $1147.70), and to be exposed to less radiation (median 7.18 vs. 16.6mSv). No patient in either group had a related 30-day revisit.Use of TRO is feasible for assessment of chest pain in the ED. Both TRAD and TRO safely evaluated patients. Prospective studies investigating this diagnostic strategy are needed to further assess this approach to ED chest pain evaluation. Chest pain is one of the most common reasons people seek medical attention in the emergency department (ED). Evaluation of non-specific chest pain often requires testing for different life-threatening clinical entities, such as aortic dissection, pulmonary embolism, or acute coronary syndrome (ACS). Several clinical and non-invasive stratification tools have been explored to avert missed cardiovascular emergency diagnoses.16Chest pain and observation units have evolved for further risk stratification of low and intermediate risk patients.22CT coronary angiography has recently been implemented as a diagnostic tool in low-risk patients for coronary artery disease.33For these reasons, we reviewed the ED course and 30-day outcome for patients with undifferentiated chest pain evaluated with TRO compared to patients who received TRAD. We hypothesized that both methodologies would be safe and effective for ED patients.Our study was performed in a single academic community hospital with 1,066 inpatient beds and 115,000 annual ED visits. It was approved by our institutional review board as an expedited review with a waiver of informed consent.This was a retrospective observational cohort study whereby the testing strategy was at the discretion of the treating physician and thus no pre-test probability assessment is available. We collected demographics and process data from the electronic medical record, including age, gender, body mass indexes, total and ED length of stay (hours), and short-term revisit details. Data abstraction was conducted electronically by our experienced outcomes research director (LQ).All adult patients (age≥18), evaluated initially in the ED for chest pain between February 2009 and January 2012, were considered for inclusion if they had one of two testing strategies: 1) Coronary CTA-TRO protocol or 2) dedicated Chest CT and provocative testing for ischemic cardiac disease (TRAD). We excluded patients who had abnormal biomarkers, abnormal ECGs, a single imaging study to evaluate for the cause of chest pain, an initial abnormal chest CT, or a high suspicion of ACS warranting admission to the hospital.Testing strategy was almost exclusively chosen by the ED physician alone. Both TRO and stress testing were available seven days per week during business hours, with the exception of stress echocardiography, which was not available on weekends. Patients who presented late in the day required transfer to the ED observation unit until evaluation could be completed. In these cases, the treating ED physician still determined the testing strategy to be carried out in observation, with rare changes to individual plans based on patient factors (i.e. inability to beta block sufficiently) rather than consultant input. Ultimately ED providers made decisions regarding further testing, discharge, or admission from the observation unit.Total hospital costs (dollars) include direct and variable patient care costs, but did not include physician professional fees. We calculated total cost using Sunrise ESPI software. Radiation doses (mSv) were estimated by radiation physicists in both nuclear medicine and imaging, based on average radiation dosing for each study and patient body mass index.Our measure of safety was revisit for major adverse cardiac event (MACE), including death, acute myocardial infarction, and revascularization, or venous thromboembolic disease within 30 days of the initial admission. All patients were reviewed for 30-day revisits to our health system, and revisit details were manually reviewed by two independent study authors, blinded to testing strategy, to identify whether revisits met adverse event criteria or were unrelated to the index visit.Data are presented as means and standard deviations if normally distributed, or medians and inter-quartile ranges if non-normal. No statistical inferences were made. We used the software JMP 9.0.2  to calculate descriptive statistics.This study investigated two populations : 829 patDemographics by group are presented in The vast majority of TRAD had stress testing that included MPI , while 71 (8.6%) underwent stress echocardiography and 51 (6.2%) underwent other risk stratification modalities, including treadmill stress testing alone, stress positron emission tomography. Seven hundred thirty-nine (89%) patients were discharged home from the ED. Within 30 days, 80 (10.5%) of those patients revisited the ED but none was related to MACE or venous thromboembolic disease.Patients evaluated with TRO tended to have a shorter ED length of stay, fewer hospital costs, and less exposure to radiation than traditional testing. No patient in the TRO or traditional cohort that was discharged from the hospital had a short-term adverse event, identifying that both methods are effective at safely ruling out short-term events. Given the low rate of life-threatening chest pain diagnoses and high rate of patient discharge from the ED, our study population represents a low risk group of patients.Limited literature exists evaluating the performance characteristics of TRO as a mono-testing strategy for emergency patients. In one study by Madder et al,A recent meta-analysis looking at TRO compared to other diagnostic modalities for nontraumatic chest pain included 11 studies and concluded that TRO is highly accurate for coronary artery disease but associated with increased radiation exposure.As technology changes, so does our ability to image with less radiation, less contrast volume, and less beta blockade. New imaging techniques have allowed for the improved safety profile of TRO protocols while obtaining adequate quality.Limitations of this study include its short follow-up period and potential to have missed revisits, adverse events, or deaths not presenting to our own institution. A short follow-up period was chosen since the alternative to admission or ED observation for further risk stratification is short-term outpatient testing. Given the similar safety profiles between the TRO and TRAD groups, it seems our patient population was sufficiently low risk, such that further outpatient testing may have been reasonable.41Because of this study’s retrospective design, we have little information regarding physician testing strategy other than clinician judgment led to testing for more for more than one etiology of chest pain in these patients. Furthermore, we have little information regarding baseline characteristics of the two groups, and as such, we cannot directly compare groups further. However, since there is no previous literature comparing TRO to a TRAD strategy in ED patients with undifferentiated chest pain, this study represents a necessary pilot investigation.Our institution frequently uses MPI to increase diagnostic accuracy for ACSFinally, our length-of-stay data may be biased by the fact that not all diagnostic tests were available 24 hours a day or seven days a week, and observation overnight was sometimes required to obtain further objective testing. At our institution, neither TRO nor TRAD was available after 7 p.m. and stress echocardiography was not available on weekends. While the difference in availability of specific choices in provocative testing may influence the length-of-stay advantage of TRO, less than 10% of the TRAD cohort received stress echocardiography implying that influence was minimal. While resource availability for chest pain rule-out pathways at all times would be ideal, this is not necessarily feasible in all institutions.42Undifferentiated chest pain evaluation by TRO in the ED appears to be a feasible, safe, and effective modality for excluding life-threatening causes of chest pain for low risk patients in the ED. Prospective studies evaluating the clinical utility of this diagnostic strategy are needed to further assess this approach to ED chest pain evaluation.


Hereditary angioedema (HAE) is characterized by unpredictable attacks of debilitating subcutaneous and mucosal edema. Gastrointestinal attacks are painful, of sudden onset and often mistaken for acute abdomen leading to unnecessary surgery. The purpose of this study was to analyze symptom presentation of gastrointestinal angioedema in pediatric and adult HAE patients.Information collected during the clinical development of ecallantide for treatment of acute HAE attacks included affected anatomic location, accompanying symptoms, medical history, and pain assessments. Efficacy endpoints included Treatment Outcome Score , a point-in-time measure of treatment response, and time to treatment response.9/L) in 23% of attacks (mean ± SD: 15.1 ± 11.27 × 109/L). A high proportion of patients reported a history of abdominal surgery, including appendectomy (23%), cholecystectomy (16.4%), and hysterectomy (8.2%). Mean TOS at 4 hours post ecallantide was 77±33 versus 29±65 for placebo. Median time to significant symptom resolution was 165 minutes  for ecallantide versus >4 hours  for placebo. Anaphylactic reactions occurred in 6 of the 149 treated patients.Forty-nine percent of 521 HAE attacks only involved abdominal symptoms. The most commonly reported abdominal symptoms were distension (77%), cramping (73%) and nausea (67%). The most common pain descriptors were tender, tiring-exhausting, aching, cramping and sickening. White blood cell counts were elevated  and in accordance with the ethical principles that have their origins in the Declaration of Helsinki. Each site that participated in the clinical trials obtained the appropriate IRB or Ethics Committee approval prior to enrolling any patients. All patients provided written informed consent prior to undergoing any study-related procedures. Pediatric patients provided written assent and their parents or guardians gave written informed consent.http://www.clinicaltrials.gov: EDEMA2 (identifier NCT01826916); EDEMA3 (identifier NCT00262080); EDEMA4 (identifier NCT00457015); and DX-88/19 (identifier NCT00456508).The following trials have been registered at  Hereditary angioedema (HAE) is a rare and potentially life-threatening disease. It is characterized by non-pitting, non-pruritic swelling of subcutaneous or submucosal tissues of the skin, extremities, genitalia, respiratory and/or gastrointestinal tracts. BecauseThe primary cause of HAE is a deficiency in C1-inhibitor (HAE-C1INH), although HAE with normal C1-INH (HAEnC1) has been described. C1-INH The reported manifestations of intestinal angioedema in the literature include abdominal pain with or without nausea, vomiting and diarrhea, and abdominal distension from ascites,8. TheseHerein, we provide prospectively collected data from adult and pediatric HAE-C1INH patients presenting with abdominal symptoms in the clinical program for ecallantide. Ecallantide is a subcutaneously administered plasma kallikrein inhibitor that was FDA approved in 2009 for the treatment of acute attacks of HAE in patients 16 years of age and older. These data provide information that should prove useful to the Gastroenterologist, Surgeon and ED Physician to consider HAE-C1INH when patients report with recurrent, unexplained abdominal distension, crampy abdominal pain with nausea.The analyses presented were generated from data collected in EDEMA0, EDEMA1®, EDEMA2®, EDEMA3®-DB, EDEMA3®-RD, EDEMA4® and DX-88/19 from patients with an HAE attack with any abdominal symptoms. All of the studies were conducted using Good Clinical Practices (GCP) and in accordance with the ethical principles that have their origins in the Declaration of Helsinki. Each site that participated in the clinical trials obtained the appropriate IRB or Ethics Committee approval prior to enrolling any patients , with a diagnosis of Type I or Type II HAE. Patients had to report to the treatment center within 8 hours of an acute HAE attack that was moderate to severe in intensity. In DX-88/19 only, patients experiencing mild symptoms were also eligible for treatment at any time after the development of symptoms. Table In the EDEMA0, EDEMA1 and EDEMA2 trials, ecallantide was administered intravenously. During the final Phase II trial (EDEMA2), subcutaneous (SC) administration of 30 mg ecallantide was introduced and was used in all subsequent trials. Data describing the baseline attack characteristics  were generated from either IV treated patients alone or were pooled from both SC and IV treated patients, including some placebo-treated patients . The data on the clinical response to ecallantide were generated only from those patients treated with SC ecallantide (the FDA-approved formulation).Baseline symptoms accompanying abdominal attacks were collected in 3 studies: EDEMA0, EDEMA1 and EDEMA2. In the SC arm of EDEMA2, as well as EDEMA3, EDEMA4 and DX-88/19 patients identified the location of their symptoms based on 5 symptom complexes: oropharyngeal head/neck , gastrointestinal (GI)/abdominal, genital/buttocks, non-oropharyngeal head/neck , and cutaneous.The McGill Pain Questionnaire (SF-MPQ) consists of 15 pain descriptors  which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The paiPatients who presented with HAE attacks with abdominal symptoms assessed their own perceptions of pain using a visual analog scale (VAS). Data from the SC arm of EDEMA2 and DX-88/19 were used for the VAS analysis. Patients were instructed to place a slash across a 100 mm long line at the position that best described their pain, with possible values ranging from 0 (no pain) to 100 (worst possible pain). Scoring took place at baseline and at 4 hours post-treatment.Treatment outcome score (TOS) is a composite measure of symptom response to treatment. For each individual symptom complex, patients assess their change in symptom severity using a categorical scale weighted by the baseline symptom complex severity  at 1, 2, 3, 4 and 24 hours post-treatment. Weighted scores across all sites are averaged to calculate TOS. A TOS value > 0 reflects improvement and the minimally important difference for the TOS was estimated to be 30.0.To measure overall response to ecallantide or placebo, patients were asked to compare how they were feeling following treatment to how they were feeling before treatment. Patients were assessed every 15 min for the first 2 hours, every 30 min for hours 2 – 4, and then at 24 hours. Response measurements were made using a 5-category scale. Responses could be “a lot better or resolved”, “a little better”, “unchanged”, “a little worse” or “a lot worse”. Beginning of improvement was the first time within 4 hours the patient reported feeling “better” (i.e. either “a little better or a lot better or resolved”). The time to significant improvement was the first time within 4 hours the patient reported feeling “a lot better or resolved”.Safety assessments included the collection of adverse events (AE) through final follow-up. An AE was defined as any untoward medical occurrence in a patient that received treatment that did not necessarily have a causal relationship with the treatment.The individual symptoms associated with abdominal attacks at baseline were collected from patients in EDEMA0, EDEMA1 and EDEMA2. Table Of all attacks with any abdominal pain N = 521), 49% presented with isolated abdominal pain only and 33% presented with abdominal pain and symptoms at another location . An elevated WBC count was measured with 64% of severe abdominal attacks compared to 34% of moderate attacks. In these 183 patients, 23% had previously received an appendectomy, 16.4% had received a cholecystectomy, 1.6% had received a bowel resection, 2.7% had an exploratory laparotomy, and 8.2% had a hysterectomy.White blood cell (WBC) count was measured in all HAE attack patients. This dataset of primary abdominal attacks included 183 patients with 569 primary abdominal attacks; defined as moderate or severe abdominal symptoms in the absence of laryngeal symptoms. In 132 of these attacks, WBC counts were elevated . Forty of 72 (56%) attacks were classified as primary abdominal attacks and 28 of 72 (40%) attacks were abdominal attacks only. As with adults, primary abdominal attacks were defined as moderate or severe abdominal symptoms in the absence of laryngeal symptoms. McGill data at baseline was collected for 50 attacks in 19 pediatric patients with any abdominal symptoms. The top 5 descriptors of abdominal pain were tender (1.92), cramping (1.64), aching (1.58), sickening (1.50) and tiring-exhausting (1.44). VAS pain data was available from 15 pediatric patients treated for 39 attacks. At baseline, the median (IQR) VAS pain score was 62  and 4 hours post-ecallantide dosing this was reduced to a median score of 11 . The McGill descriptors and VAS pain scores in pediatric patients are numerically similar to those reported above for the overall population.Table Figure The time to beginning of improvement and the time to significant improvement were collected in patients with HAE attacks with any abdominal symptoms. The median time (95% CI) to beginning of improvement was 54 minutes  following SC ecallantide administration versus 114 minutes in placebo treated patients. The median time (95% CI) to significant symptom resolution was 165 minutes  for ecallantide treated attacks versus > 4 hours  for placebo.The safety profile of ecallantide was similar to previous reports, with potentially serious hypersensitivity representing the main safety concern. Anaphylaxis (based on NIAID criteria) occurreDiagnosis of HAE-C1INH in patients with recurrent abdominal pain can be challenging, especially in the approximately 50% of cases that present only with abdominal symptoms. These patients are very likely to be referred to a Gastroenterologist at some point, particularly given that abdominal symptoms occur in approximately 80% of patients and on aHistorical data suggests that up to 80% of HAE patients have recurrent abdominal pain. This peThe percentage of HAE attacks with symptoms of diarrhea 14%) and vomiting (21%) reported during the ecallantide development program were lower than those reported in previous studies. In two retrospective reports from Bork and colleagues, the percentage of attacks with vomiting were 83.3% and 73.3%, while 41.8% and 40.6% of attacks had symptoms of diarrhea% and vom. The reaWhite blood cell (WBC) count is often used in the differential diagnosis of acute abdominal pain and was collected in patients with primary abdominal attacks in the ecallantide development program. Interestingly, WBC count was elevated in ~25% of attacks and was more likely to be elevated in attacks rated as severe. This finding is in agreement with several published case reports of abdominal HAE attacks and therefore suggests that elevated WBC count is not a reliable measure to include or exclude HAE in the differential diagnosis of abdominal pain,25. IndeTo date, there is no reliable marker to define abdominal angioedema upon presentation of symptoms. Even in patients with a confirmed diagnosis of HAE, a diagnosis of an abdominal attack depends upon clinical judgment and the demonstrated efficacy of specific treatments. In undiagnosed patients, once HAE is suspected, blood tests can be used to confirm the diagnosis but these results will not be available for diagnosis and treatment in the initial emergency setting. The initial screening test is C4 blood levels, which will be low in HAE patients at baseline and even lower during an acute attack. However, a reduced C4 level during an attack does not identify the presence or absence of angioedema. The C4 test is inexpensive, common to most hospital laboratories, and typically has a high sensitivity and specificity, with at least 95% of HAE-C1INH patients showing a reduced C4 level during remission and virtually 100% showing reduced C4 during an attack. If the There are now several therapeutic options available for the treatment of HAE. These include both long-term prophylaxis, as well as the treatment of acute attacks but studies of comparative effectiveness among treatments have not been conducted. Attenuated androgens have long been used for HAE prophylaxis but can have serious side-effects,30. CINREach of the HAE therapies have demonstrated efficacy in the management and treatment of HAE but also carry a risk of harm. As stated in the package inserts and reported in the literature, the use of C1 Esterase Inhibitor (Human) products is associated with serious arterial and venous thromboembolic events,32,35. TIn summary, patients that present with attacks of recurrent abdominal pain that completely resolve in the absence of other symptoms are challenging to diagnose. The data from this study provide information that should aid the Gastroenterologist in suspecting the diagnosis of HAE in patients with such unexplained bouts of severe abdominal pain. Patients with HAE are likely to have intermittent exacerbations of moderate to severe, poorly localized pain, described as tender, tiring-or exhausting, aching cramping or sickening. Elevation of white blood cells frequently occurs during severe abdominal attacks and may lead to exploratory laparotomy for concern of other more common conditions. As Gastroenterologists increase their awareness of HAE, patients will be diagnosed earlier to receive both timely and effective treatment.Dyax Corp designed and provided funding for the studies described in this article. Dr. Rubinstein has no conflicts to declare. Dr. Bousvaros reports personal fees from Dyax Corp, personal fees from Millennium pharmaceuticals, grants and personal fees from Merck pharmaceuticals, personal fees from Up to Date, personal fees from Imedex, non-financial support from Prometheus, non-financial support from Nutricia, personal fees from Cubist, outside the submitted work. Dr. Sheffer reports serving as a principle investigator for Dyax Corp. Leslie Stolz, PhD and Joseph Biedenkapp, PhD are full-time employees of Dyax Corp. Chris Stevens, MD is a consultant for Dyax Corp. The authors declare that they have no competing interests.ER participated in the analysis and interpretation of data and reviewed and revised the article; LS participated in the conception and design, analysis and interpretation of data and reviewed and revised the article; AS participated in the conception and design, analysis and interpretation of data and reviewed and revised the article; CS participated in the conception and design, analysis and interpretation of data and reviewed and revised the article; AB participated in the analysis and interpretation of data and reviewed and revised the article; all authors approved the final article as submitted.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-230X/14/71/prepubList of IRB/IECs in the clinical development program for ecallantide.Click here for file


Pain assessment is an important component of pain management and health professionals require valid tools to assess pain to guide their pain management decisions. The study sought to select, develop, and validate context-appropriate unidimensional pain scales for pain assessment among adult post-operative patients.A mixed methods design was adopted. The study was conducted at two hospitals in Accra, Ghana. The qualitative phase involved 17 patients and 25 nurses, and the quantitative phase involved 150 post-operative patients. Qualitative data was collected iteratively through individual interviews and focus groups.Two existing pain scales  and one new pain scale  were validated. The psychometric properties of the three scales were assessed when patients had fully recovered from anesthesia. The CCPS had higher scale preference than NRS and FPS. Convergent validity was very good and significant (0.70–0.75). Inter-rater reliability was high (0.923–0.928) and all the scales were sensitive to change in the intensity or level of pain experienced before and after analgesia such as paracetamol and diclofenac suppositories, injectable pethidine, and oral tramadol had been administered.Using a valid tool for pain assessment gives the clinician an objective criterion for pain management. Due to the subjective nature of pain, consideration of socio-cultural factors for the particular context ensures that the appropriate tool is used. Pain is a subjective phenomenon, and its expression and management is influenced by the culture of the individual due to the socialization process –3. ConteOver the years, pain assessment tools have been validated among various populations globally –7. HowevThe development of context appropriate pain scales is done with the active participation of users of the scales. An iterative inductive process ensures that participants make input at every stage of the development of the scale. The literature so far indicates that only the Twi or Ghanaian version of the VAS has been developed and validated in Ghana among Twi speaking post-operative gynecological patients. The original VAS was also validated in the same study . HoweverTo demonstrate convergent validity, there will be a significant positive correlation between the scores of the pain scales.There will be a high inter-rater consistency between pain scores of two different assessors.Pain scores before analgesia will significantly differ from pain scores after analgesia .This study had two phases. Phase One, the qualitative phase, was to select and develop appropriate scales for pain intensity assessment. Phase Two, the quantitative phase, sought to validate or assess the psychometric properties of the pain scales that emerged from phase one, among adult post-operative patients. The hypotheses for the validation of the pain scales were:The study employed a multi-phase approach to achieve its purpose. An inductive iterative qualitative process was used to select and develop appropriate scales for pain assessment. The qualitative phase adopted an exploratory descriptive method which allowed identification of features of pain scales and development of a scale which were consistent with the culture of the participants in the study. The philosophy of the qualitative approach was that the perspectives, preferences and interpretations of individuals within a specific socio-cultural context differ  and shouThe first phase of the study was conducted at a tertiary health facility  and a regional hospital  in Accra, Ghana. The second phase was done at the tertiary health facility. The two hospitals have facilities for surgery where various types of surgical procedures are undertaken.The study was approved by the Institutional Review Board of the Noguchi Memorial Institute for Medical Research. Permission was obtained from the authorities of the two hospitals, and individual informed consent obtained from participants both orally and written depending on the participants’ preference and educational background. Anonymity and confidentiality were ensured and participants were assigned identification codes. Identification codes were used to represent the participants: P1-P17 for patients and N1 to N25 for nurses in Phase One and A1-A150 to represent patients in Phase Two.Nurses and post-operative patients on the surgical wards participated in the study. The inclusion criteria were nurses with a minimum of 6 months working experience on the surgical ward and ambulant patients on the 5th–7th day after surgery who were not in pain. The 6 months clinical experience was considered adequate exposure to enable nurses’ share their experiences on patients’ pain assessment. Patients in pain may have difficulty sharing their experiences because of the pain. Patients and nurses who did not meet the inclusion criteria or give informed consent were excluded.Purposive sampling technique was employed to recruit participants who met the criteria. The qualitative phase involved individual interviews and focus group discussions. Individual interviews and focus group discussions were used to ensure that ideas for context appropriate pain scale features were generated and discussed from a variety of sources. In contrast to individual interviews, focus groups permitted participants to discuss pain scales. Individual in-depth interviews and focus groups were conducted iteratively to develop and select pain scales. Interviews and discussions were done at a place and time convenient for participants. The participants were allowed to express themselves in the language they were fluent in. Thus, the patients’ interviews were conducted in the local Twi dialect and the nurses’ in English. The interviews and discussions lasted 30 to 45 min. The interviews were recorded and transcribed, while notes were taken during focus group discussions. The first author who is fluent in English and Twi conducted the interviews and moderated the focus groups, and a research assistant took detailed notes during the discussions. This ensured consistency in the data collection process.The individual interviews involved 18 participants (7 patients and 11 nurses) to generate features of appropriate pain scales. Interviews stopped when data was saturated. During the individual interviews, pain assessment of participants, use of pain scales, and features of pain scales in relation to the context of the study were explored. These were probed in relation to the culture of the patients and nurses. The ideas identified through concurrent content analysis specific to pain scales were discussed during the focus groups. The features generated that were consistent with existing scales, such as numbers and faces pain scales, were selected for discussion during the focus groups. Thus different formats of existing scales were presented and discussed.In addition, the new culturally specific pain scale features that emerged were developed into scales with appropriate English descriptors for focus group discussions to ensure that the scale and descriptors were consistent with the cultural expression of pain. Participants were actively involved with the choice of English descriptors of the new scale and also discussed those of the existing scales. A research assistant developed all the scales in this study. None of the scales were translated because the primary focus and design of this study was not to translate existing pain scales. We aimed to select, develop and assess the psychometric properties of context appropriate pain scales. The authors are conscious of this limitation and suggest future studies could translate the scales validated in this study using the common local languages in Ghana such as Twi, Ga and Ewe.Four focus groups were conducted iteratively to develop the new pain scales. The focus groups were made up of two nurses and two patients groups. The number of participants in each nurses’ group was 5 to 7 and consisted of both sexes. The patients’ groups were made up of 5 participants each. Detailed notes were taken during the discussions on recommendations for refinement of the scales. The decision to discard a scale was thus reached by consensus and not by the research team. Different participants were used for the interviews and the discussions to avoid participant fatigue and bias in the development of the scale.Qualitative data was transcribed and read several times to identify the participants’ views on features of pain scales through coding. The notes taken during the focus group discussions were also coded to ensure that any new features of pain scales were incorporated in the analysis. Concurrent content analysis and the iterative process was used to select and develop the appropriate scales. The features identified that were similar to existing scales guided the selection of two existing scales for validation in Phase Two. The data was managed with the NVivo software version 9.Inter-rater reliability was assessed at 5 to 10 min intervals between RA1 and RA2 to demonstrate that if different practitioners administered the scales to the same patient or patients with similar pain intensity, consistent results will be obtainedSensitivity to change was assessed by administering the pain scale pre-analgesia and 30 min post-analgesia. Analgesia administration did not take the form of experiment (treatment group and control group) because patients were given different analgesics as prescribed on the ward.Convergent validity was assessed on post-operative days 1, 2 and 3. There was a single assessment at the same time each day because it was assumed that post-operative pain decreased daily after surgery.Sample, procedures and data analysis for the quantitative phase: The validation and data collection lasted a period of 4 weeks during which post-operative patients on the surgical and maternity wards of the Korle-bu Teaching Hospital participated. The hospital’s average monthly surgeries of 454  was used as the accessible population. With a criterion level of 0.05, we used the Yamane 1967) simplified sample size formula to determine the appropriate sample size of 212. However, 150 patients (70.75 %) met the inclusion criteria during the period of data collection. In the domain of validation or assessing the psychometric properties of pain scales, previous studies have demonstrated that a sample of 150 is acceptable and the type of analysis employed is also acceptable 7 simplif, 14. A cScale preference was assessed by ordering scales–patients indicated their preferred pain scale for assessment in order of preference, after the final pain assessment on post-operative day 3. The assessment criteria were consistent with similar psychometric assessment studies such as the time interval of assessment , 16. It t test and one-way analysis of variance (ANOVA) for normally distributed variables and Kruskal Wallis was used for non-normally distributed variables. Proportions were compared using Chi-square and Fisher exact test, in case of small cells. Bonferroni test was used to adjust for alpha for multiple pair wise comparison. P-value <0 0.05 was considered statistically significant.Statistical analysis was performed using statistical package for the social sciences (SPSS) version 22 . Descriptive statistics were presented in mean and standard deviation (SD), frequency and percentage. Means were compared between groups using Student Convergent validity by Pearson’s correlation coefficient, inter-rater reliability by interclass correlation coefficient (ICC) , sensitiCopyright permission was sought from Elsevier to use the Wong-baker FACES pain scale  for clinical pain assessment. The 0–10 NRS is a free access pain scale. Identification codes used for scales were: Scale 1 = 0–10 NRS (S1); Scale 2 = Wong-Baker Faces Pain Scale (S2); Scale 3 = Colour-Circle pain Scale (S3).Processes undertaken to ensure rigor or validity and reliability included effective probing to ensure that participants’ ideas on features of pain were fully explored. Moderation of focus group discussions and interviews were conducted by the first author who is experienced in qualitative data collection. Concurrent and iterative data collection and analysis were done to ensure identification and development of pain scales that were appropriate for the context of the study. All the authors were involved in data verification and analysis to ensure that participants’ views were captured. Detailed audit trail was maintained so that future researchers can confirm the processes used in this study.Patients who were involved in the scale development and selection did not participate in the clinical validation of the scales as they had been discharged at the time of validation. Also, two research assistants assessed pain for all the patients in this study to avoid participant familiarity, which could confound the data generated especially where the assessor demonstrated negative attitude during pain assessment. Quantitative data was checked for completeness and omissions before analysis to avoid error in analysis.The results of this study are presented in two sections; Section One presents the tool development process  and Section Two reports the psychometric properties (quantitative) findings.The development and selection of the pain scales involved 25 clinical nurses and 17 post-operative patients (for both interviews and focus group discussions). The nurses consisted of 12 staff nurses, 10 nursing officers, and three senior nursing officers. The 5 male and 20 female nurses who were involved in the pain scale development were between 26 and 50 years of age and had 6 to 15 years experience in surgical nursing. With regard to education, four nurses had nursing certificates, 17 had diplomas, and four held bachelor degrees in nursing. The 17 post-operative patients consisted of seven males and 10 females between the ages of 25 to 45 years. Ethnic breakdown of these participants were as follows: Twi (22), Ewe (8), Ga (7), and Dagomba (5).The initial interviews generated six features of potential pain scales  and the iterative data collection and analysis process further refined and reduced the number of scales to the three scales validated. Features of pain scales identified in the interviews guided selection of existing scales that was consistent with the data (FPS and NRS). Also, new ideas were developed according to participants’ suggestions using a 6-point scale (CCPS). A research assistant developed all the potential new pain scales. All the scales were subjected to focus group discussions iteratively. Sample interview data from which potential pain scales were generated is presented in Table Iterative focus groups indicated that focus groups One and Two discussed the 6 scales and participants preferred four scales . Focus groups Three and Four discussed the four scales and further merged plain circle and the colour circle into one new scale  Fig. . The scaSix plain circles each of 1″ height and width, were inserted from auto shapes in Microsoft Word, onto the page. The circles starting from a size of 0.4″ in diameter were increased in sizes of 0.3″, until the 6th circle. This was aimed at differentiating the various levels of pain. Each circle was filled with different colours, with their borders having the same colours, to differentiate between the various pain levels, hence the entire pain scale comprises the following colours sequentially: 1–Linear Up Gradient–Dark; 2–Horizontal Gradient–Accent 6; 3–Gold Accent 4, Lighter 60 %; 4–Blue; 5–Red; and 6–Horizontal Gradient–Dark. All drawings were grouped together with their captions for consistency and uniformity of interpretation.The colour-circle pain scale Fig.  was deveAll the 3 scales that emerged had word descriptors and numbers to ensure uniformity in interpretation and documentation of findings.In Phase Two, 150 surgical patients with a mean age of 33.1 years SD 12.2) were enrolled in the study. Approximately 77 % of the patients were females, with 33 % of them less than 30 years old. Most (66.0 %) of the patients were post caesarian, 15.33 % post laparotomy and 4.67 % had lower limb amputation. Out of the male patients, 40 % had laparotomy. Majority (48.0 %) of the patients were of the Twi ethnic background and the least (6.0 %) were from the Dagomba ethnic background (Table .2 were eP = 0.01). The hypothesis that there will be a significant correlation between the scores of the pain scales (i.e. Hypothesis One) was therefore supported.As shown in Table We used interclass correlation coefficient (ICC) to assess the inter-rater reliability of the scales. Interclass correlation of the scales was high (range 0.92–0.93) indicating a very high level of agreement between scores from two raters (RA1 and RA2), supporting Hypothesis Two. The interclass correlation coefficient for S1 was 0.92 which indicated a high level of reliability. Eighty percent (120) of the patients had identical readings, 16 % (24) had readings with discrepancy of 1.0, 2.3 % (5) had readings with discrepancy of 2 and only one patient had readings with discrepancy of 5.The interclass correlation coefficient for S2 was 0.93, also indicating a high level of inter-rater reliability. The mean difference between the two readings was 0.05; the difference between the two readings was as large as 3.5 % of mean readings. The patients that had identical readings were 88.0 % (132), discrepancy in readings of 1.0 was 10 % (15) and discrepancy in readings of 2.0 was 2 % (3).P = 0.886; S2: F = 0.633, P = 0.532; S3 F = 0.289, P = 0.749). These findings demonstrate that if different practitioners administered the scales to the same patient or patients with similar pain intensities, similar or consistent results would be obtained.The interclass correlation coefficient for S3 was 0.93. The mean difference between the two readings was 0.07 and the difference between the two readings as large as 4 % of mean readings. Out of the 150 patients, 92 % (138) had identical readings, 6.6 % (10) had discrepancies in readings of 1 and 1.3 % (2) had discrepancies in the reading of 2. In addition, we found no difference of inter-rater reliability of scales among the age groups  = 0.122, P = 0.001).Sensitivity was assessed for all three scales by measuring change in pain intensity before and after analgesia administration , older (40 years and above) patients (51.6 %) had more preference for S3 while the patients less than 40 years showed no specific preference  and in descending order, the preference of the scales among the other two thirds was S3, S2, and S1. There was significant variation of preference among the age groups (ce Table .Table 7PThe participatory and inductive approach adopted in this study is consistent with approaches adopted by previous researchers in developing scales , 20. ThiDifferent colours have various meanings among different ethnic groups in Ghana. Red and black are used for funerals or are associated with death and mourning and red represents danger especially among the Twi and Ga people who formed the majority in this study. The other colours used for the scale have been associated with the following in Ghana: blue represents tenderness or love, yellow shows royalty or glory, green means newness or fertility and white means purity or joy . In thisThere seems to be global agreement that red represents severe pain as used in other pain scales , 22. HowNurses are admonished to understand the patient’s socio-cultural context in order to use the appropriate pain assessment tools and pain management techniques . The nurIt is noted that the assessment of validity and reliability of pain scales among a population include the assessment of scale preference, content validity, convergent validity, construct validity, inter-rater reliability, and sensitivity to change depending on the type of pain scale –27. HencThe ability of patients to report pain using the three pain scales supports previous observation that pain assessment involves an estimation of pain intensity according to pre-determined objective criteria such as the use of pain scales . HoweverThe effective use of self-report pain scales hinges on adequate patient education. It has been observed that inadequate knowledge of patients on the use of pain scales could result in errors in pain assessment and this can lead to detrimental effects such as administering wrong doses of analgesics . Hence, The study was limited to adult post-operative patients, hence future studies could validate pain scales among children and those with chronic pain. Also, multidimensional pain assessment tools could be validated that afford comprehensive pain assessment. The tools can be translated into the major languages in Ghana to enhance pain assessment in clinical practice and for future pain intervention research. The CCPS was the most preferred in this study. However, patients with colour blindness or sight problems may be unable to use the CCPS without assistance.Although pain is a subjective abstract phenomenon, the use of the appropriate scale can elicit valid findings that can be used to guide health professionals in their care. The development and validation of the CCPS supports the need to consider the socio-cultural factors in the choice of appropriate assessment scales for a particular population. It would be necessary to involve the Ghana Health Service and other stakeholders to introduce formal pain assessment in Ghana based on the findings from this study.


It is not so infrequent that a patient reports severe pain with a clear focus in/around the eye that looks like an atypical facial pain/persistent idiopathic facial pain. All the patients fulfilled DMS-IV criteria for depression or bipolar disorder-I and sleep and benzodiazepines overuse were reported as the only escape and cure treatment. This may or may not appear as a psychological flight reaction characterized by vegetative signs , or a meTo evidence possible causes of therapeutic mistakes in persistent facial pain, chiefly affecting the eye area.Observation started 26 years ago. Recruited patients  suffering from atypical facial pain chiefly affecting the area of the eyes, were previously treated with all the substances commonly used in such a pain, namely tricyclics, negative modulators of excitatory aminoacids, selective serotonin reuptake inhibitors and norepinephrine reuptake inhibitors given as 3-month treatments and narcotics given as hospital short-lasting (5 days) regimen. Neither indomethacin 50 mg nor sumatriptan 6 mg, parenterally administered, induced relief.None of the patients, except one, achieved pain relief, i.e. decrease vs baseline 17% on VAS 0-10. Only narcotics induced a benefit, which vanished when treatment was discontinued. Magnifiers observation focusing cilia showed that all non-responder patients were affected by demodex as evidenced with the use of a magnifying glass. The specific treatment for curing demodex completely relieved non-responders’ pain. Later , episodic migraine without aura appeared in 25 patients.a) When a disease is rare it does not mean it can be neglected; b) an inherited abnormality of the central nervous system, namely inheritable hyperalgesia pattern seemingly provokes a redundancy of painful expression that may lead to diagnostic mistakes.Written informed consent to publish was obtained from the patient(s).


Pain emerges as a challenge in the treatment of leprosy patients. In this study, we describe the prevalence and type of pain in patients with leprosy, and its effect on patients’ quality of life in an endemic area of Northeast Brazil.p = 0.001), leprosy reactions (p = 0.004) and lower quality of life. Most patients with neuropathic pain were treated with steroids, despite their low efficacy for this type of pain.A cross-sectional survey of 260 patients attending leprosy reference centres in Sergipe, Northeast Brazil was conducted. Individuals were assessed for the presence and type of pain, skin sensory loss, peripheral nerve enlargement, touch and pinprick sensations, mechanical allodynia and nerve palpation. Participants completed the Douleur Neuropathique 4 questionnaire, and we also used the Brief Pain Inventory scale and the World Health Organization Quality of Life-BREF instrument to arrive at our results. One hundred and ninety-five (75 %) patients reported pain, mostly of the neuropathic type. Pain was moderate in 84 (43.1 %) and severe in 94 (48.2 %) participants. The presence of pain was associated with disability  contains supplementary material, which is available to authorized users. Please see Additional file More than 250,000 new leprosy cases are reported annually worldwide . LeprosyThe presence of pain affects physical and emotional wellbeing; leads to social isolation, relationship and psychological problems, and an inability to work ; and incIn this report, we describe the prevalence and type of pain in leprosy patients, and the effect that pain has on patients’ QoL in an endemic area of Brazil.A cross-sectional survey of patients aged >15 years who attended the University Hospital Leprosy Clinic and the Leprosy and Tuberculosis Reference Centre in Aracaju was conducted. These are the two leprosy reference centres in Sergipe, Northeast Brazil. All consecutive patients who visited the centres between February and June 2015, who were receiving multidrug therapy for leprosy or who had been previously treated for leprosy and were returning to the centres for follow-up, were invited to participate. Patients with diabetes, those who drank excessive amounts of alcohol, those who were known to be HIV positive, or those who had mental and physical conditions that could interfere with the assessment of pain were excluded.Participants were interviewed using a structured questionnaire to obtain demographic and clinical information, disability grade, QoL, and the presence and intensity of pain in the three months leading up to enrolment in the study. Leprosy was classified as paucibacillary or multibacillary (MB), and as tuberculoid, borderline, lepromatous or as having an indeterminate clinical presentation, using the World Health Organization (WHO) classification . Nerves Individuals were appraised for skin sensory losses and enlargement of peripheral nerves by assessing touch, pinprick sensations, mechanical allodynia and palpation of nerves. Patients completed the Douleur Neuropathique 4 questionnaire in Portuguese . Scores Sample size was calculated to detect a difference of 20 % in the QoL between cases with and without pain, with α = 5 % and 80 % power. We hypothesised that two-thirds of patients would experience pain, and that a patient with pain would be more likely to have low QoL . A sample size of 260 patients (195 who had pain) was required to examine this hypothesis.U test was used to assess differences between QoL domains, and Spearman’s correlation coefficients were used to describe the relationship between pain intensity and QoL. P-values <5 % were considered to be statistically significant.The WHO analysis syntax for SPSS Statistics software package version 20.0  was used to calculate QoL scores. The chi-square test was used to compare discrete variables of patients with and without pain. Variables associated with pain in the bivariate analysis were entered into logistic regression models using backwards-stepwise procedures. The Mann–Whitney The study was approved by the Human Research Ethics Committee at the Federal University of Sergipe (CAAE: 31078114.3.0000.5546). Informed written consent was obtained from all participants. Parents or guardians provided written informed consent for minors.p = 0.03), live in rural areas , and experience disability  and leprosy reactions . Leprosy reactions were present in 68 % (113/166) of patients with neuropathic pain and 58.6 % (17/29) of patients with nociceptive pain. The pain intensity was moderate in 84 (43.1 %) and severe in 94 (48.2 %) patients. Participants with neuropathic pain had higher pain intensity than those with nociceptive pain . Pain affected participants’ general activities , mood , walking ability , work  and sleep . A significant correlation was observed between pain severity and the perception of limitations (p < 0.001). Patients with neuropathic pain had been prescribed steroids , analgesics  or anti-inflammatories , but only 28 % of all patients experiencing pain reported that the treatment improved it.Two hundred and sixty patients were enrolled in the study, with 195 (75.0 %) experiencing pain, as shown in Table p < 0.001), psychological health (p < 0.001) and environment (p < 0.001) domains than patients without pain, and patients with neuropathic pain had the lowest scores for all domains , psychological health , social relationships  and environment  domains.Pain intensity was associated with decreasing QoL in the physical health , deformities and stigma, and low QoL , 13. It In this study, patients with neuropathic pain had lower QoL than patients without pain. This is in contrast to another study that reported that neuropathic pain mostly affects patients in the physical health domain . PerhapsNeuropathic pain had a higher prevalence in this study than expected; most studies report that it’s prevalent in 11 % to 70 % of patients , 14–16. In the present study, the presence of leprosy reactions was associated with pain, as previously reported by others , 9. AlthOur study had several limitations. Firstly, we did not investigate QoL changes over time. The analysis was limited to referred patients, who would have had a higher frequency of complications than those treated at health centres, thus overstating the prevalence of pain among leprosy patients. Our findings therefore reflect the magnitude of the problem of patients attending reference centres like the ones in Brazil.Pain is a frequent co-morbidity associated with low QoL in leprosy patients. All leprosy patients should be systematically evaluated to identify the presence and type of pain so that appropriate clinical management can be applied. Longitudinal studies are needed to describe changes in the occurrence and type of pain over the course of treatment and rehabilitation, and its impact on QoL. Because neuropathic pain is very common in leprosy patients and because it has a greater impact on a patient’s QoL than nociceptive pain, this highlights the need for research to identify efficacious treatments appropriate for specific types of pain.


Postoperative pain management is of great importance in perioperative anesthetic care. Transversus abdominis plane (TAP) block has been described as an effective technique to reduce postoperative pain and morphine consumption after open lower abdominal operations. Meanwhile, local anesthetic infiltration (LAI) is also commonly used as a traditional method. However, the effectiveness of these two methods has not been compared before.A meta-analysis of all relevant randomized controlled trials (RCTs) was conducted to compare the efficacy of single shot TAP block with that of single shot LAI for postoperative analgesia in adults. Major medical databases and trial registries were searched for published and unpublished RCTs. The endpoints include postoperative visual analog scale (VAS) pain score, morphine requirement, and rate of postoperative nausea and vomiting (PONV). For continuous data, weighted mean differences (WMDs) were formulated; for dichotomous data, risk ratios (RR) were calculated. Results were derived using a random-/fixed-effects model with 95% confidence interval (CI).Four RCTs, encompassing 96 TAP-block and 100 LAI patients, were included in the final analysis. Patients in the TAP-block group had lower VAS pain scores 24 hours postoperatively compared with the LAI group, both at rest . There were no significant between-group differences in 24-hour postoperative morphine requirements, the rates if PONV or VAS pain scores at 2 and 4 h postoperatively.TAP block and LAI provide comparable short-term postoperative analgesia, but TAP block has better long-lasting effect.The online version of this article (doi:10.1186/1471-2253-14-121) contains supplementary material, which is available to authorized users. Acute postoperative pain is a common problem encountered not only by pain specialists, but also by all medical professionals in everyday practice. Pain maTransversus abdominis plane (TAP) block, first described by Kuppuvelumani et al. in 1993 and formSingle shot local anesthetic infiltration (LAI) is also a commonly used method for reducing postoperative pain, 19. Paitransvers abdominis plane block or transverse abdominis plane block or TAP block. No limitations with respect to sex, human or animal studies, language, or publication year were applied. The search was performed independently by two authors (N. Y. and X. L.) according to the validated methods of the PRISMA statement = 0), and P < 0.05 was considered to be statistically significant.Data analysis was performed with Revman 5.2  and Stata Statistical Software, Release 9 . For continuous data, Hedges’ g statistic was used to calculate weighted mean difference (WMD) and 95% confidence interval (CI). Inverse variance was used for continuous outcome variables. Binary data was summarized as risk ratios (RR) and 95% CI. The heterogeneity of the estimators was tested using IPotential publication bias was investigated with funnel plot of the SMD against the mean difference of the study, which was used as the main graphical method. To supplement the funnel-plot approach, Egger linear regression was used to test for publication bias using quantitative analysis.The database search produced 1044 studies, of which four were eligible for analysis after applying exclusion criteria–10, 12. 2 = 97%, P < 0.00001). A random-effects model was used, there was no significant difference in mean VAS pain score 2 h postoperatively between patients who received LAI and those with TAP block . A random-effects model was used, there was no significant difference in mean VAS pain score 2 h postoperatively between patients who received LAI and those with TAP block . A random-effects model was used, and there was no significant difference in mean VAS pain score 4 h postoperatively between patients who received LAI and those with TAP block . A random-effects model was used, and there was no significant difference in mean VAS pain score at 4 h between patients who had received LAI and those who had received TAP block . A random-effects model was used, and there was significant reduction in mean VAS pain score at 24 h postoperation in patients received TAP block compared with those who had LAI . A fixed-effects model was used, and there was significant reduction in mean VAS pain score at 24 h postoperation in patients received TAP block compared with those who had LAI . A random-effects model was used, and there was no significant difference in mean morphine requirements at 24 h between patients received TAP block and those with LAI . A fixed-effects model was used, and there was no significant difference in mean rate of PONV at 24 h between the TAP group and LAI group . Further limitations include differences in block technique and timing of administration.Our review findings raise another important clinical question regarding time and cost. LAI, performed under direct visualization, is simple and quick; ultrasound-guided TAP block is operator-dependent and time-consuming; thus, future research are required to demonstrate the time requirements and cost efficiency of these two methods.TAP block is comparable to LAI for short-term analgesia; it could also provide better long-lasting analgesia especially at 24 h after surgery. Current evidence is insufficient to conclude that TAP block could reduce the requirements for postoperative morphine and associated side effects as compared to LAI. Further RCTs should be performed to figure out the different benefit of these two methods.Figure S2. Risk of bias summary: review authors’ judgments about each risk of bias item for each included study. Figure S3. Funnel plot of VAS score in 2 hours at rest between TAP and LAI groups. Figure S4. Funnel plot of VAS score in 2 hours on movement between TAP and LAI groups. Figure S5. Funnel plot of VAS score in 4 hours at rest between TAP and LAI groups. Figure S6. Funnel plot of VAS score in 4 hours on movement between TAP and LAI groups. Figure S7. Funnel plot of VAS score in 24 hours at rest between TAP and LAI groups. Figure S8. Funnel plot of VAS score in 24 hours on movement between TAP and LAI groups. Figure S9. Funnel plot of mean morphine requirements (mg) 24 hours following surgery between TAP block and local infiltration. Figure S10. Funnel plot of postoperative nausea and vomiting (PONV) rate 24 hours following surgery between TAP block and local infiltration. (DOCX 350 KB)Additional file 1: Figure S1: Risk of bias graph: review authors’ judgments about each risk of bias item presented as percentages across all included studies.


There are many different reasons why patients could be experiencing pain in the gluteal area. Previous studies have shown an association between radicular low back pain (LBP) and gluteal pain (GP). Studies locating the specific level responsible for gluteal pain in lumbar disc hernias have rarely been reported.All patients with lumbar disc herniation (LDH) in the Kanghua hospital from 2010 to 2014 were recruited. All patients underwent a lumbar spine MRI to clarify their LDH diagnosis, and patients were allocated to a GP group and a non-GP group. To determine the cause and effect relationship between LDH and GP, all of the patients were subjected to percutaneous endoscopic lumbar discectomy (PELD).A total of 286 cases were included according to the inclusive criteria, with 168 cases in the GP group and 118 cases in the non-GP group. Of these, in the GP group, 159 cases involved the L4/5 level and 9 cases involved the L5/S1 level, while in the non-GP group, 43 cases involved the L4/5 level and 48 cases involved the L5/S1 level. PELD was performed in both groups. Gluteal pain gradually disappeared after surgery in all of the patients. Gluteal pain recrudesced in a patient with recurrent disc herniation (L4/5).As a clinical finding, gluteal pain is related to low lumbar disc hernia. The L4/5 level is the main level responsible for gluteal pain in lumbar disc hernia. No patients with gluteal pain exhibited involvement at the L3/4 level.The online version of this article (doi:10.1186/s12891-016-1204-7) contains supplementary material, which is available to authorized users. Among people suffer from low back pain (LBP) during their life time , for 80 However, in clinical practice, complaints of gluteal and radicular pain in the affected leg have always been diagnosed as deep gluteal syndrome (DGS). DGS is a condition in which the sciatic nerve is compressed by any structures in the deep gluteal space. The chief symptoms of DGS are buttock pain and affected leg pain. The system is similar to nerve root pain associated with LDH.4 Therefore, it is important to make a definite diagnosis for correct treatment.Previous studies have shown an association between radicular LBP and GP –7. StudiAll cases of LDH in the Kanghua hospital from 2010 to 2014 were recruited. An investigator who was blinded to LDH-related gluteal pain took the patients’ histories and performed the physical examinations. Patients were evaluated for the presence or absence of gluteal pain and were allocated to a GP group and a non-GP group. All patients underwent a lumbar spine MRI to clarify their LDH diagnosis. To determine the cause and effect relationship between LDH and GP, percutaneous endoscopic lumbar discectomy (PELD) was performed to determine the relative presence of gluteal pain with LDH. Patients were evaluated again for the presence or absence of gluteal pain after surgery.The inclusion criteria were as follows: all LDH cases with PELD surgery to determine the relationship between gluteal pain and LDH. The cases in which gluteal pain disappeared after surgery were included. The exclusion criteria were as follows: we excluded patients with hip disease, piriformis syndrome, muscle strain, cancer, arthritis of the sacroiliac joints and multiple levels of LDH. The cases in which gluteal pain did not disappear after surgery were excluded.Patients were followed up regularly by the operating surgeon for 24 months after their surgeries. The incidences of complications in the surgery groups, including the incidence of neurological complications and ODI improvement rates, were assessed.The associations between level and gluteal pain and the incidence of neurological complications were evaluated in a 2 × 2 contingency table. ODI improvement rates were evaluated using a Mann-Whitney Test.From 2010 to 2014, 286 cases were included according to the inclusion criteria. Table P < 0.001), indicating that the L4/5 level was a primary cause in gluteal-related LBP. No cases of gluteal pain involved the L3/4 level.Table p < 0.001, and from 71.0 ± 7.9 to 15.1 ± 7.9, p < 0.001, respectively). A total of 63.1 % of the patients in the GP group felt no pain after surgery. One month after their surgeries, gluteal pain disappeared in all of the patients in the GP group, which indicated that LDH was responsible for gluteal pain. The pain appeared again in a patient with L4/5 disc recurrence, confirming the hypothesis.Percutaneous endoscopic lumbar discectomy surgeries were performed in the GP group. In both the GP and non-GP groups, the mean ODI values decreased significantly after surgery .With regard to the incidence of neurological complications in the GP group, there were 19 cases of lower limb numbness during surgery, accounting for 11.3 % of the GP group and including two cases of foot drop and two cases of cerebrospinal leakage. These patients recovered 6–12 months after surgery. Regarding the incidence of neurological complications in the epidural anaesthesia group, there were 11 cases of lower limb numbness during surgery, accounting for 10.2 % of the non-GP group and including one case of foot drop and two cases of cerebrospinal leakage. These patients recovered 6–12 months after surgery. No significant difference was observed regarding the incidences of neurological complications between the two groups  due to existing dorsal root ganglion (DRG) injury is a unique complication of PELD that accounts for the majority of neurological complications. As shown in Table The clinical implications of this study are as follows. Firstly, because the results suggest a clear relationship between L4/5 disc herniation and gluteal pain, GP assessment could help in diagnosing patients with L4/5 disc herniation. Secondly, beyond the accepted therapies aimed at the gluteal area, PELD may be suggested if the diagnosis of LDH is clarified, which might improve outcomes. This hypothesis should be tested in further anatomical studies.This study is a retrospective study in which only the cases subjected to PELD surgery were included. Additionally, this study is not multi-centre. All of these factors may lead to biases. However, the goal of this study was to locate the specific level that was responsible for gluteal pain in LDH. In this regard, we found that L4/5 disc hernias were a main factor in LDH-related gluteal pain. Further anatomical studies may be undertaken to support these results.


To describe treatment and referral patterns and National Health Service resource use inpatients with chronic pain associated with low back pain or osteoarthritis, from aPrimary Care perspective.Osteoarthritis and low back pain are the two commonest debilitating causes of chronicpain, with high health and social costs, and particularly important in primary care.Understanding current practice and resource use in their management will inform healthservice and educational requirements and the design and optimisation of future care.n=264). Data on management of chronic pain werecollected retrospectively from patients’ records for three years from diagnosis (‘newlydiagnosed’ patients) or for the most recent three years (‘established’ patients).Multi-centre, retrospective, descriptive study of adults (⩾18 years) with chronic painarising from low back pain or osteoarthritis, identified through primary care records.Five general practices in Scotland, England (two), Northern Ireland and Wales. Allpatients with a diagnosis of low back pain or osteoarthritis made on or before01/09/2006 who had received three or more prescriptions for pain medication wereidentified and a sub-sample randomly selected then consented to an in-depth review oftheir medical records (Patients received a wide variety of pain medications with no overall common prescribingpattern. GP visits represented the majority of the resource use and ‘newly diagnosed’patients were significantly more likely to visit their GP for pain management than‘established’ patients. Although ‘newly diagnosed’ patients had more referrals outsidethe GP practice, the number of visits to secondary care for pain management was similarfor both groups.This retrospective study confirmed the complexity of managing these causes of chronicpain and the associated high resource use. It provides an in-depth picture ofprescribing and referral patterns and of resource use. One GP in each practice wasidentified as a Principal Investigator (PI) on the basis of his interest in chronicpain.etal., et al., n=264).Using the practice database, the PI at each site identified all patients with a diagnosisof LBP or OA (based on Read coding) on or before 01/09/2006, aged ⩾18 years, without adiagnosis of cancer-related pain, and who had received three or more prescriptions forpain medication. Of these, 250 patients at each practice were randomly selected andinvited to consent to the study and have a researcher review their medical records. Weidentified individuals with clinically significant chronic pain (Smith Data were collected from two cohorts of patients: in ‘newly diagnosed’ patients (ie OA orLBP diagnosed between 01/09/2004 and 01/09/2006) data from the first three years afterdiagnosis were collected to describe the initial stages of management; in ‘establisheddisease’ patients (ie diagnosed before 01/09/2004) data from the most recent three yearswere collected to provide data on recent pain management, later in the course of thecondition.Anonymised data relating to analgesic prescriptions, consultations, and referrals between01/09/2004 and 01/09/2009 were collected from primary care paper records and electronicsystems between April and July 2010 by researchers working to data collection guidelines.Data were collected on pain medications prescribed at least once by GPs or NursePrescribers. The drugs included analgesics, antidepressants and anti-epileptics where theclinical record clearly showed that the prescription was for pain.BritishNational Formulary .Analysis was undertaken in MS Excel and SPSS for Windows. Statistical analysis employedthe Fisher Exact Test of Probability and the Kruskal–Wallis test.Ethical approval was obtained from Outer South East London Research Ethics Committee(09/HO805/42) and NHS R&D approval was obtained in each study area.n=140), and incorrect or late completion of the consent form(n=202).From a total of 1250 identified patients, 606 (49%) consented and 264 (44%) of these wereeligible. Reasons for ineligibility were: at least three prescriptions not issued were prescribed five or fewer different drugs at least once forpain management over the three-year study period and a significant minority (38%)received six or more different drugs .Similarn=44) wereprescribed at least one type of ‘strong opioid’: [n=7 (13%) ‘newlydiagnosed’ and n=37 (18%) ‘established’ patients]: 26 (10%) receivedbuprenorphine, 14 (5%) morphine, 10 (4%) fentanyl patch and 9 (4%) oxycodone (‘Weak’ opioids were prescribed to 161 (61%) patients and the majority of these patientsreceived a tramadol product  were prescribed to 58% of patients[35 (66%) ‘newly diagnosed’ and 118 (56%) ‘established’ patients]. Adjuvant analgesicdrugs such as tricyclic antidepressants and anti-epileptics were prescribed for 154patients (58%). The most prevalent adjuvant analgesic prescribed was amitriptyline, to80 (30%) patients, followed by pregabalin and gabapentin to 29 (11%) and 26 (10%) ofpatients, respectively.Co-prescribed medication to prevent or manage unwanted effects of pain medication wasprescribed to 145 (55%) patients, including laxatives (41%), gastro-protective agents(48%) and anti-emetics (11%) . RatesoReasons for changing pain medication were documented in only 457 (21%) of the 2188recorded changes over the study period.Non-drug interventions such as physiotherapy and acupuncture were prescribed for 34(64%) ‘newly diagnosed’ and 86 (41%) ‘established’ patients during the three-year studyperiod. Overall, 105 (40%) patients were recorded as receiving physiotherapy during thestudy period [29 (55%) ‘newly diagnosed’ and 76 (35%) ‘established’]. Exercises wererecommended and recorded by the GP for 6% overall . Acupuncture was similarly recommended and recorded for 6% overall  and transcutaneous electrical nerve stimulation for3% overall . One episode each of psychotherapy,occupational therapy, osteopathy and heat pads was recorded.P<0.01)].However, ‘established’ patients were referred to a wider range of specialties andproviders. In ‘newly diagnosed’ patients where data were available, the mean (SD) timefrom diagnosis to first referral was 9.4 (10.0) months (range 0–34.3). Physiotherapy wasthe most common referral (55% ‘newly diagnosed’ patients) with a mean of 0.26referrals/patient/year over the first three years since diagnosis.NHS resources in primary and secondary care were heavily used by these patients .Table 5DMost GP practice visits for pain management (67%) were with a GP, 29% were with aPractice Nurse and 4% were with other practice staff.P<0.001). (Mean pain-related GP visits per year: 3.9 for ‘newlydiagnosed’ and 3.0 for ‘established’.)‘Newly diagnosed’ patients visited their GP practice significantly more frequently forpain-related reasons than did ‘established’ patients, both in the first year afterdiagnosis (median 4 visits) and in the average per year (3.7) among the ‘newlydiagnosed’ patients, compared with 2.3 per year among ‘established’ patients(P<0.005). (Meannon-pain-related GP visits per year were 7.7 for ‘newly diagnosed’ and 9.4 for‘established’ patients.)For non-pain-related visits, ‘established’ patients visited their practicesignificantly more frequently than ‘newly diagnosed’ patient. This was true in both thefirst year (median 5.0 visits) and the average per year (6.3), compared with 8.3 peryear among ‘established’ patients , reviewing patients early and frequently,and referring for specialist opinion in the event of non-response. This study suggests thatwhile treatment may be individualised, many patients are not referred to specialists untilrelatively late in their clinical course, perhaps leading to a delay in providing optimaltreatment.The activity in pain management is greater among the ‘newly diagnosed’ patients as seen inthe pattern of referrals to specialists, where ‘newly diagnosed’ patients were more likelyto be referred than ‘established’ patients (81 versus 68%) with a significantly higherreferral rate for pain management in the first three years since diagnosis . Further development of evidence-based referral guidelines would be helpfulto guide the long-term management of this chronic condition and defining what constitutesappropriate levels of referral for all stages of chronic pain management.Only 8% of all patients in this study were referred to a pain clinic, demonstrating thatthe majority of pain management is delivered by GPs in primary care. ‘Newly diagnosed’patients attended their GP surgery for pain-related visits significantly more often than‘established’ patients, with the most visits occurring in the first year. Further study isneeded to determine to what extent the reduction in visit frequency over time is associatedwith well-controlled pain, requiring only infrequent monitoring, compared with perceivedexhaustion of therapeutic options and acceptance by patients of a degree of uncontrolledpain.The opposite trend was found for non-pain-related visits with ‘established’ patientsattending their GP surgery significantly more often than ‘newly diagnosed’ patients. Whilethis may reflect the older age of the ‘established’ group of patients, and consequentco-morbidities, further study is needed to understand the nature of the non-pain-relatedvisits and relationship, if any, with control and manifestation of pain.etal., As may be expected, GPs appeared to broadly follow the ‘analgesic ladder’ approach toanalgesic prescribing. More than half the patients (58%) received NSAIDs. Whilst NSAID useis recommended for OA and LBP NICE, ; 2009, tet al., et al., et al., Most patients (87%) were prescribed non-opioid analgesics and compound analgesicscontaining a ‘weak’ opioid (73%). However, in comparison, the number of patients receiving‘strong’ opioids was considerably lower (17%). There is good evidence for the safety andeffectiveness of strong opioids in non-malignant pain (Kalso The widespread prescription of weak opioids was notable, despite limited evidence of theiradded benefit over simple analgesics (Li Wan Po and Zhang, et al., et al., et al., There is increasing focus on non-pharmacological approaches to managing chronic pain, andsome recent studies have found some of these to be effective in primary care (HeymansThese results from a retrospective study of a cohort of patients with chronic OA pain orLBP offer a useful picture, previously unavailable, of the management of thisresource-intensive group of patients. It seems that prescribing is complex, often involvingthe management of side effects, and does not conform to a particular pattern. The furtherdevelopment of evidence-based guidelines for primary care treatment and referral for chronicpain could be of great benefit. The need for further research in primary care is thereforeapparent, and so too is the need for more education on chronic pain for primary careprofessionals.