Long-term outcomes of patients undergoing extensive fusions for adolescent idiopathic scoliosis (AIS) have conflicting results. Moskowitz found uninstrumented scoliosis fusion patients had similar back pain as a normal age matched population. Recently, long-term outcomes of patients with Harrington rod instrumentation were reviewed and found similar functional outcome scores to non-scoliosis patients, with trending toward worse outcomes when fusions extended to L4. Our study examined long-term functional outcomes of patients treated with Cotrel-Dubousset (CD) instrumentation and determined whether distal level of instrumented fusion (L4 and L5) correlate with increased back pain or lower functional level.p < 0.05.Retrospective review of AIS surgeries from 1986 to 1996 was undertaken. Patient demographics and surgical data were collected via case-note audit. Patients were contacted and asked to complete a series of functional outcome questionnaires including visual analog scales (VAS) for pain, Short-Form 36 (SF-36), Scoliosis Research Society 22 (SRS-22) and Oswestry Disability Index (ODI) for function. ANOVA technique categorically compared outcome scores to most distal levels of fusion. Linear regression compared patient reported outcomes to time elapsed since surgery. Statistical significance was p = 0.92). ODI was 15.36, with six patients' ODI >20. No relationship was shown between ODI and distal level of fusion (p = 0.72). SF-36 and SRS 22 values were also not related to distal level of instrumentation. Patient reported VAS back pain scores , ODI , and SF-36 and SRS-22 were not worse in patients with longer follow-up over time. Back pain and certain functional score subcategories of the SF-36 and SRS-22 trended toward improved results over time.One hundred twelve patients were identified, 50 patients were contacted, and 22 agreed to participation and completed a full assessment. Follow-up time since surgery ranged from 15 to 26 years and age ranged from 30 to 43 years. Six patients reported daily VAS back pain of ≥5; with a mean of 2.5. Back pain was not associated with level of distal fusion (Most patients who underwent multi-segment spinal fixation appeared to do well long-term, with minimal back pain. Lowest instrumented segment did not appear to be associated with increased back pain after 15 to 25 years follow-up. The origin of surgical treatment for adolescent idiopathic scoliosis (AIS) dates back to 1911 when Hibbs  became tRecently, investigators have critically looked at outcome scores to assess the quality of patient outcomes for long posterior spinal fusions for AIS. In the 1970s, the results of fusion in Risser’s original cohort, who had been followed for over 34 years, were reviewed . Risser’In contrast, Bartie et al.  reviewedAlthough the Cotrel-Dubousset (CD) instrumentation has been utilized for almost 30 years, there are only a few mid-term studies and no long-term studies on patient functional outcomes after CD instrumentation. The purpose of our study was to examine the long-term functional outcomes of patients treated with CD instrumentation. We believe it is important to critically evaluate patient functional outcome scores and determine how AIS treated with modern instrumented fusion techniques affects the quality of life. Our specific aim was to determine whether the distal level of instrumented fusion (L4 and L5) correlated with increased back pain or lower functional level.This study was performed with the approval of our institutional review boards (IRB) at Albany Medical Center and the State University of New York Upstate Medical University and in accordance with the boards’ ethics regulations. After IRB approval, the AIS surgeries that were completed between 1986 and 1999 by the senior author (SA) were examined. The author had treated the majority of the AIS patients in the Upstate, New York (Syracuse) area. These patients were seen, evaluated, and treated according to the standard care of practice. All patients underwent a complete history and physical examination along with standing x-rays; and later, went on to have instrumented spinal fusions completed using three dimensional instrumentations according to the CD technique with posterior only spinal fusions.In a retrospective manner, all patient demographic data were collected to include: age, sex, race, skeletal maturity determined by Risser Classification, type, and magnitude of curve determined by the Cobb Measurement. This data was collected from the medical chart reporting the initial history and physical examinations as well as from the initial x-rays taken at the time the patients presented to the offices. The levels selected for spinal fusion were reviewed; and specifically, the most distal level selected for this fusion procedure was noted. Additionally, we recorded whether further extension of the initial instrumented fusion was performed at a later date. From this data collection, a review of records was performed prior to contacting patients for interview. This was to ensure the subjects were at least 18 years of age at this time for purposes of data collection. We also ensured that the contacted patients had undergone surgery for their scoliosis while under the age of 18. There were no other inclusion/exclusion criteria.If the subjects agreed to be contacted and provided phone numbers, a study investigator interviewed the patients and asked explicitly if they had any current back pain, had undergone any subsequent spinal surgery, and, if they would be willing to submit written questionnaires. The questionnaires sent contained: Oswestry Disability Index (ODI); Short-Form 36 (SF-36); Scoliosis Research Society 22 (SRS-22), and a horizontal VAS for back  Patientsp < 0.05.Outcomes reported by these patients were categorized by extent of distal fusion  and compared. Statistical analysis was completed using a Chi-square technique for categorical variables, and ANOVA technique for categorically comparing the patient reported outcomes to the most distal level of fusion. Linear regression compared patient reported outcomes to the time elapsed since surgery. Statistical significance was accepted at One hundred twelve patients were identified who met all inclusion criteria to include posterior only CD constructs and identifiable contact information. Fifty of the 112 patients were able to be contacted via a telephone interview, and 62 patients could not be contacted via telephone as they did not have a working phone number on file or refused the phone call. Twenty-two of the 50 agreed to complete the full assessment of outcome scores. The follow-up time since surgery ranged from 15 to 26 years (mean 20 years). Follow-up patient age ranged from 30 to 43 years of age (mean 35 years).p = 0.92) and were not worse in patients with longer follow-up (r2 = 0.18 and p = 0.05). Regression analysis of VAS scores trended to decrease with increased time from surgery  . None of the SRS-22 subcategories of function (4.47), pain (4.02), self-image (3.75), mental health (4.15), or satisfaction with management (4.34) correlated with distal fusion level. . . None of the SF-36 subcategories (mean); role limitations due to physical health (87.78), limitations due to emotional well-being (92.58), energy (63.92), emotional well-being (80.68), social function (88.07) and pain (77.84)) correlated with distal fusion level .The overall mean SF-36 of instrumented patients was calculated at 72.05. (Table Table p = 0.051), patients’ reported VAS back pain trended toward better (lower) scores with increased follow-up (R-squared = 0.17).The majority of patients who underwent multi-segment spinal fixation for AIS, reported in their telephone interview that they did not have back pain on a daily basis. Of the 22 patients who completed the full assessment of questionnaires sent , 15 had a VAS score of less than 3 cm, indicating the overall mean VAS score of the patients to be relatively low. However, six of 22 patients studied reported significant back pain (5 or greater). One third reported moderate back pain VAS (3 or greater). While not statistically significant  did not correlate with lowest instrumented segment. These results are in direct contrast to the studies of Cochran which showed a significant increase in back pain with fusion at or lower than L4 . This diDue to the substantial differences in the instrumentation, we believe that studies such as those by Cochran may over-estimate long-term morbidity when applied to populations treated with CD instrumentation principles. From the findings in our study, we suggest less of an emphasis be placed on avoidance of fusions to L4 and L5 levels in patients being surgically treated for AIS with CD instrumentation.Functional outcome scores  had varying results in patients with longer follow-up. With some parameters in SRS-22 subcategories of self-image, mental health, satisfaction with management and total SRS score, patients had significantly better scores further out from surgery. SF-36 scores, though not statistically significant, did show improved trends in limitations due to emotional well-being, social function, and pain, as well as, having a significant improvement in the SF-36 subcategory of energy over time. The vast majority of these subcategories involved are psychosocial in nature. We had hypothesized that scores would not worsen over time, but did not anticipate a trend toward improved psychosocial function and less pain (with a trend toward lower VAS scores) over time from surgery.An obvious limitation of the study is the relatively low response rate. Only half of the patients contacted agreed to complete full functional outcomes. Patients with worse outcomes may have been less inclined to participate, but it is impossible to know exactly how this response rate affected out study outcome. Every attempt to contact study participants was made within the regulations set forth by our IRB. Our study was further limited by the lack of x-rays or clinical follow-up. Clinical outcomes have been associated with factors, such as, pseudoarthrosis and spinal alignment . This isAs a final note the authors of this study do receive funding from spinal implant companies in relation to research un-related to the current study. Disclosing potential bias is important. The current study was self-funded which would lend toward the removal of potential bais. These patients had their spinal instrumentation placed 15–25 years prior and were not part of any device investigation funded or unfunded current or present which also adds to the transparency of the study.Our study substantiates that low back pain does not correlate with distal level of fusion in patients instrumented with the Cotrel-Dubousset technique for adolescent idiopathic scoliosis. This is in direct contradiction with earlier studies which utilized Harrington instrumentation. We believe this may be due to the newer methods of instrumentation employed and how they affect both planes of the deformity . Our dat


To investigate whether pain-related fears are mediators for reducing disability and pain in patients with Complex Regional Pain Syndrome type 1 when treating with Pain Exposure Physical Therapy.An explorative secondary analysis of a randomised controlled trial.Fifty-six patients with Complex Regional Pain Syndrome type 1.The experimental group received Pain Exposure Physical Therapy in a maximum of five treatment sessions; the control group received conventional treatment following the Dutch multidisciplinary guideline.Levels of disability, pain, and pain-related fears  were measured at baseline and after 3, 6, and 9 months follow-up.The experimental group had a significantly larger decrease in disability of 7.77 points (95% CI 1.09 to 14.45) and in pain of 1.83 points (95% CI 0.44 to 3.23) over nine months than the control group. The potential mediators pain-related fears decreased significantly in both groups, but there were no significant differences between groups, which indicated that there was no mediation.The reduction of pain-related fears was comparable in both groups. We found no indication that pain-related fears mediate the larger reduction of disability and pain in patients with Complex Regional Pain Syndrome type 1 treated with Pain Exposure Physical Therapy compared to conventional treatment.NCT00817128International Clinical Trials Registry  Complex Regional Pain Syndrome type 1 (CRPS-1) is a debilitating condition that develops spontaneously or after physical injury, and is characterized by pain and sensory, autonomic, motor, and/or trophic changes .Aberrant neurogenic inflammation and vasomotor dysfunction cause increased temperature, skin reddening, protein extravasation, oedema, and augmented nociceptive stimulation, whereas maladaptive cortical reorganization contributes to experienced pain and motor dysfunction . The degThe role of psychological factors has also been considered, both in the development of CRPS-1 and in its progression . It has One of the models that could explain the associations between fear and CRPS-1 is the fear-avoidance model  7]. Acc. Acc7]. In a meta-analysis about pain-related fear and disability in patients with acute and chronic pain, Zale et al. concluded that pain-related fear might be an important target for treatments intended to reduce pain-related disability . LookingAccording to the principles of the fear-avoidance model, pain catastrophizing and pain-related fear have to be treated first, in order to restore functional abilities . HoweverPEPT is a patient-centred physical therapy, tailored towards improving activities in daily life, using progressive-loading exercises, desensitization and “self-forced” use, in which patients have to encourage themselves to use their affected extremity, both during treatment exercises and in daily activities, without the use of medication. Whereas graded exposure therapy focuses on fear, PEPT puts disuse at the centre. It takes patients to their physiological boundaries to regain normal functional abilities. Ek et al. studied PEPT in a cohort of 106 adult patients with long-lasting CRPS-1. Function improved in 90% of patients, and full functional recovery was observed in 46% of patients . In a muIn Dutch clinical practice, clinicians usually treat patients with CRPS-1 with conventional therapy, following the national guideline, which is based on systematic reviews of the available studies at the time of conception . The guiRecently, we performed a randomized controlled trial (RCT), comparing the effectiveness of PEPT and conventional treatment in patients with CRPS-1, the PEPTOC trial . The primary analysis showed that only the active range of motion improved significantly more after PEPT than after conventional treatment. Further per protocol analysis, however, showed an additional larger reduction of disability and pain in patients treated with PEPT than patients treated conventionally.Following the results of the multiple single-case study  and the The PEPTOC trial was designed as a randomized controlled trial with blinding of the assessor. We collected data at baseline and after three, six, and nine months follow-up . The priInclusion criteria for the PEPTOC trial were 1) positive scoring on the research diagnostic criteria for CRPS as proposed by Harden et al. (shown below) , 2) age Diagnostic CRPS criteria Continuing pain, which is disproportionate to any inciting event;Sensory: reports of hyperalgesia and/or allodyniaVasomotor: reports of temperature asymmetry, skin color changes and/or skin color asymmetrySudomotor/edema: reports of edema, sweating changes and/or sweating asymmetryMotor/trophic: reports of decreased range of motion, motor dysfunction and/or trophic changesAt least one symptom in each of the four following categories;Sensory: evidence of hyperalgesia and/or allodyniaVasomotor: evidence of temperature asymmetry (>1°C), skin color changes and/or skin color asymmetrySudomotor/edema: evidence of edema, sweating changes and/or sweating asymmetryMotor/trophic: evidence of decreased range of motion, motor dysfunction and/or trophic changesAt least one sign in two or more of the following categories:There is no other diagnosis that better explains the signs and symptoms.After baseline measurements, patients received either the experimental treatment Pain Exposure Physical Therapy (PEPT) or the conventional control treatment (CONV).At the start of treatment with PEPT all medication aimed at CRPS-1, including analgesics, was stopped, as use of medication is not part of the treatment. PEPT was conducted by two physical therapists together. Patients received thorough education about their condition, the working mechanism of pain  and pain-related avoidance behaviour, and the rationale and content of PEPT. Therapists explained that pain is not a sign of injury, but rather a “false warning sign”: pain does hurt, but does not mean harm.Therapists explained that they acknowledge that the patients might temporarily experience pain, but ignored further expressions of pain and taught the patients and their spouses to do the same. The therapists explained that because of improved function, the pain would eventually diminish ,15,17.After thorough instruction about PEPT, the patients, along with their spouses, set their personal, functional treatment goals. The therapists acted mainly as instructors and coaches, and confirmed and rewarded progression with positive feedback.The therapists confidently touched the affected limb and passively moved it beyond the active range of motion. They then stimulated the patients and their spouses to do the same. They convinced the patients that moving and touching the affected limb is safe.Further treatment consisted of progressive-loading exercises, focused on specific daily activities and quality of movement, and other regular physical therapy techniques, like muscle strength training and joint mobility exercises. Patients learned how to decrease their skin sensitivity for touch and pressure by performing self-massage and “self-forced” use of the affected extremity during exercises and in daily activities. Patients had to perform the exercises at home and incorporate them in their daily life, whereas their spouses had to ensure that the exercises were performed correctly. Spouses were instructed to ignore the patients’ pain behaviour and change their protective role into a motivating and coaching one.PEPT consists of a maximum of five treatment sessions and is time-contingent, in contrast to the usual pain-contingent physical therapy. The content and the number of treatment sessions are not influenced by experienced pain. More details on Pain Exposure Physical Therapy have been reported elsewhere ,15,17.Conventional treatment (CONV) was based on the current Dutch national guideline and included pharmacological interventions combined with physical therapy in a pain-contingent manner . The recThe outcomes of interest for the mediation analysis were pain-related disability, pain, fear-avoidance beliefs, pain catastrophizing, and fear of movement and (re)injury (kinesiophobia).Pain-related disability was measured with the Pain Disability Index (PDI), a 7-item questionnaire with a range of 0–70 points that assesses to what extent daily activities are disrupted by pain. The questions comprise aspects of family and home responsibilities, recreation, social activity, occupation, sexual behaviour, self care, and life-support activities. We used a Dutch language version, which has proven to be valid and reliable in patients with musculoskeletal pain .We measured pain on a visual analogue scale (VAS-pain), a widely used, reliable and valid tool for the assessment of pain . A scoreThe Fear-Avoidance Beliefs Questionnaire (FABQ) measures patients’ beliefs about how their pain influences work and physical activities ,22. The For measuring pain catastrophizing, we used the Dutch language Pain Catastrophizing Scale (PCS), a 13-item questionnaire with questions about the three aspects of catastrophizing: rumination, magnification and helplessness . The PCSWe measured fear of movement and (re)injury using the Tampa Scale for Kinesiophobia-11 (TSK-11) , a briefBecause of the exploratory nature of this particular study, we did not abide to the randomization protocol and analysed all patients according to the treatment they received from the beginning of the trial.We used descriptive analyses to describe patient characteristics. 1) had to be smaller than the total effect (arrow c) [1)/c x 100% [According to the steps described by Baron and Kenny , we planarrow c) . On the c x 100% .We used linear mixed models with unstructured repeated covariance, treatment and measurement in time as factors and outcome at baseline as covariate, to determine the between-group differences on the dependent variables over time. Because 26.8% of the patients switched groups prior to treatment initiation, shifts in baseline characteristics occurred. Therefore, we added these as potential confounders  to the analysis. If they affected the between-group estimates by more than 10%, we considered them as confounders and added them to the models . Linear www.clinicaltrials.gov, NCT00817128, and at www.trialregister.nl, NTR 2090.The Ethics Committee on Research Involving Human Subjects of Arnhem and Nijmegen, The Netherlands (CMO Regio Arnhem-Nijmegen), approved this study. The study is registered at All participants provided both oral and written informed consent prior to data collection.Between January 2009 and June 2011, 56 patients were included in the PEPTOC trial. Thirty-five patients received Pain Exposure Physical Therapy and 21 patients received conventional treatment. Disability and pain improved significantly in both groups, as is shown in The analysis showed a significant total effect of PEPT on disability, with an estimated mean between-group difference of 7.8 points  in favour of PEPT. Pain improved on average 1.8 points more in the PEPT group than in de CONV group   after adFear-avoidance beliefs, catastrophizing, and kinesiophobia decreased significantly in both groups , Table 2Because there were no significant effects of treatment on pain-related fears, we did not perform step 3 of the mediation analysis, nor could we assess the proportion of the mediated effect.With this exploratory study on the working mechanism of Pain Exposure Physical Therapy, we found that in this population the effect of PEPT, compared to conventional treatment, on disability and pain was not mediated by pain-related fears. We also found that in both treatment groups pain-related fears improved significantly without primarily focusing at fear reduction. According to this study however, reduction of fear does not explain the working mechanism of PEPT beyond conventional treatment.In contrast to standard physical therapy and other conventional treatment modalities , PEPT doIn patients with CRPS-1, shrinkage of the cortical representation of the affected extremity in the primary somatosensory cortex has been observed . There iInvolving spouses in the treatment of CRPS-1 is an important component of the treatment. Not only should spouses know what patients are dealing with and should they ensure that the patients perform their exercises and support them, it is important that spouses ignore patients’ expressions of pain. It is demonstrated that spouses who reinforce pain can cause a 2.5-fold increase in patients’ brain response to pain, measured with electroencephalographic potentials, compared to spouses who ignore pain or punish the patients for expressing pain .Our exploratory study showed that patients with CRPS-1 can be effectively treated, even though treatment is not primarily focused on reduction of pain or fear. However, since we found no between-group difference in reduction of fear, we cannot conclude that this treatment effect was caused by a reduction in pain-related fears.A number of reasons can be identified for why we did not find a difference in decrease of fear between PEPT and CONV. The most obvious reason is that there is no difference in fear reduction between the two treatments. It is possible that both treatments reduce fear in their own way. With conventional treatment, there is definitely some attention for the fear patients experience; patients do not have to cross their own “boundaries”. Reinforcement of success experiences is used to show that the patients do not have to fear movement nor pain. PEPT, on the other hand, enhances the patients’ self-efficacy and stresses the patients to ignore their pain and use their affected limb despite possibly eliciting pain. As a result of their success experiences, this could explain a reduction of fear in patients treated with PEPT. In both cases, reduction of fear could be related to the experience that no harm is done. Apart from an effect of treatment, the reduction of fear in both groups could be due to a favourable natural course . When paIn the multiple single-case study by Van de Meent et al., using a similar cohort, there was however no reduction in kinesiophobia during a baseline period of three months prior to treatment initiation . This suWe did not abide to the randomization protocol. Because with this particular study we wanted to explore the working mechanism of PEPT, we looked at the sole effects of both treatments. Therefore, we analysed the patients according to the treatment they received from the beginning of the trial, while adjusting for confounding. The sample size calculation of the trial was consequently based on detecting differences in clinical effectiveness between the two interventions, rather than on mediation effects. As a consequence, the sample size may not have been adequate to identify mediation effects, which may have led to a type II error. To reduce the chance of a type II error and because of the exploratory nature of this study, we also interpreted the results of the analysis using an alpha of 0.10. However, this did not change our conclusion.One of the inclusion criteria was first assessment between 3 and 24 months after the inciting event, yet the median duration of complaints for the participants in this study was rather short (6 months). Only 12.5% of the patients reported at our outpatient clinic ≥12 months after the inciting event. This reduces the generalizability of our results to a population with more chronic patients.During the screening process, we did not systematically check for psychological or psychiatric comorbidities by means of questionnaires or psychological evaluation. Possible differences could add some explanation to our data. However, we did perform a thorough history taking in all patients during screening, which did not reveal the presence of such comorbidities. Throughout the trial, a psychologist was available in case there were concerns about the psychological condition of patients.Because this is the first study that explored possible mediation of pain-related fears in treating patients with CRPS-1 with PEPT, there are no other studies to compare our results with. However, there are several trials on treatment modalities focusing on reduction of fear in patients with CRPS-1. One of these trials  studiedAlthough we cannot compare the results of both trials, because we included patients with a relatively short history, disregarding their levels of fear, we can state that it appears that in an average population with a relatively short duration of complaints, CRPS-1 can be effectively treated, without primarily focusing on fear, thus avoiding long and costly treatment. After thorough education that pain is not a sign of injury and moving is not harmful but rather promotes quick improvement, it is possible to reduce disability and pain in a safe and effective manner.Because, in contrast to PEPT, GEXP applies graded exposure, the duration of treatment is longer , soft tIn conclusion, our analysis showed that there was no indication that reduction of disability and pain by PEPT, in comparison to conventional treatment, was mediated by pain-related fears, regardless of whether the reduction of fear was caused by treatment or by any other factor. Hence, this seems to indicate that pain-related fears do not have to be treated specifically in order to reduce disability and pain effectively in patients with CRPS-1.


Background: General anesthesia draws attention to the most commonly used modalities for post cesarean delivery pain relief in systemic administration of opioids, while the administration of small dose of intrathecal opioid during spinal anesthesia can be a possible alternative. The aim of this study was to evaluate the effects of buprenorphine on cesarean section prescribed intrathecally.Methods: This double blind randomized clinical trial study was conducted in patients for cesarean section under spinal anesthesia. The patients were randomly divided into case and control groups. Case group (208 patients) received 65-70 mg of 5% lidocaine plus 0.2 ml of buprenorphine while the same amount of 5% lidocaine diluted with 0.2 ml of normal saline was given to 234 cases in the control group. Hemodynamic changes and neonatal APGAR scores  were recorded. Pain score was recorded according to the visual analog scale. This study was registered in the Iranian Registry of clinical Trials; IRCT2013022112552N1.Results: The mean age of case and control groups was 24.4±5.38 and 26.84±5.42 years, respectively. Systolic blood pressure was not significantly different until the 45th minute but diastolic blood pressure showed a significant difference at the 15th and the 60th minutes (P<0.001). Heart rate changes were significantly different between cases and controls at the initial 5th, 15th and after 60th minutes (P<0.001). Pain-free period was significantly different between two groups (1.25 h versus 18.73 h) (P<0.001).Conclusion: The results show that prescription of intratechal buprenorphine prolongs the duration of analgesia without any significant considerable side effects. The increasing cesarean section rate is a global issue in the developed and developing countries . It has It is proposed that by adding a small dose of opioid to local anesthetic solution, the duration of analgesia can be significantly prolonged without increasing side effects. Intratecal narcotics enhance the sensory blockade of local anesthetics without affecting the sympathetic activity . In thisBuprenorphine is a long-acting, lipid soluble, mixed agonist-antagonist opioid that has been used in clinical practice since 1979. Buprenorphine is a thebaine derivative with a partial agonist activity at the μ-opioid receptor. Buprenorphine is administered via intravenous, intramuscular, sublingual, and intrathecal routs. It has been used for the treatment of acute/chronic pain and also as a supplement drug in anesthesia. Since buprenorphine dissociates slowly from μ-opioid receptor, it has long duration of action and less addiction potential . Like otThe aim of this study was to evaluate the efficacy and the adverse effects of intrathecal buprenorphine in cesarean section while there is a paucity of published literature assessing buprenorphine when prescribed intrathecally.From June 2010 to December 2012 all patient candidates for elective cesarean section and in ASA class I (American Society of Anesthesiology) aged 17-41 years were included for this study. The patients with local infection at the site of lumbar puncture, any contraindication for lumbar puncture, disorders of the spine, alcoholic patients or those with history of drug abuse, collagen vascular disease, NSAIDs or corticosteroid use, psychotic problems, bleeding disorders, space occupying lesions of the brain, fetal or maternal contraindications for spinal anesthesia, severe fetus distress, blood pressure more than 140/90 mmHg, gestational diabetes, cardiopulmonary diseases and a height of less than 150 cm were excluded. The main variable in this study was pain and the sample size was calculated on the basis of mean differences of pain perception (VAS score) in other studies. Based on clinical experience and review of literature, an educated guess was made that a difference in pain score about 1-2 according to VAS scale between two groups would be statistically significant. Using the data and assuming a study with 90% power and probability of making a type I error of 5%, a sample size of four hundred patients was required to obtain the statistical significance. So, assuming the equal distribution of patients in both groups, four hundred and forty-two healthy full term pregnant women incorporated in the study were randomly divided into two groups using a computer-generated randomization table (simple random sampling) according to their profile number:case group (lidocaine and buprenorphine) and control group (lidocaine). The explanation regarding the procedure and study, education regarding VAS score, and necessary written informed consent was done during the preoperative checkup at visit. Standard ASA fasting guidelines were followed by all patients upon arrival at the operation theatre, intravenous access was established with an 18G intravenous cannula in a large vein of forearm, and ringer or normal saline (0.9%) was infused before anesthesia (300-500 ml) and vital signs  were measured and recorded. Then the patients were positioned into a sitting position with the help of a nurse and pulse-oximeter was connected. Dural puncture was done after prep in L3-L4 or L4-L5 levels and after assuring about the CSF, anesthetic drug was infused during 10-15 seconds into the subarachnoid space. Then the patients were positioned back to the supine position and ECG monitoring, non-invasive automatic blood pressure evaluation and pulse-oximetry were performed. Spinal anesthesia was performed for all cases. To ensure blinding, the randomly allocated coded syringes of drugs were prepared by a clinical anesthesia resident but did not perform subarachnoid block or record the outcome intraoperative and postoperative period. The investigator and the attending anesthesiologist performing the study were blinded to the content of the drugs contained in each syringe.th minutes after delivery. In the case group, 65-70 mg (1.3 to 1.4 ml) of 5% lidocaine plus 0.2 ml of buprenorphine was infused and in the control group, 65-70 mg (1.3-1.4 ml) of 5% lidocaine plus 0.2 ml of 0.9% normal saline was infused. Hemodynamic factors like blood pressure and heart rate were recorded before and at 1, 3, 5, 15, 30, 45, 60 and 75 minutes after spinal anesthesia. Severe decrease in hemodynamic elements was treated appropriately. Surgery was started about 4-5 minutes after induction. 1500-1800 ml isotonic serum was given intravenously to patients during the surgery. Neonatal APGAR  score was recorded at the 1st and the 5Oxygen (3 L/min) was administered throughout the procedure via nasal cannula. Intraoperative fluid management was done in relation to body weight of the patient, vital signs, and intraoperative losses. At the end of the surgery, the patients were transferred to the recovery room and monitored by pulseoximetery and NIBP (non invasive blood pressure). Postoperatively, all patients in the study were visited daily and were asked for the presence of a headache and any accompanying symptoms. The pain onset was recorded according to the visual analog scale (VAS) with facial expression , 11. BasIf there was a moderate to severe pain, 0.5 mg/kg IV pethidine was administrated. In the ward, if there was a moderate pain diclofenac suppository (100 mg) was given, in case of, severe pain or no response to the suppository, Intramuscular pethidine was prescribed. All patients were under observation with regard to probable buprenorphine side effects. This study was registered in the Iranian Registry of Clinical Trials of the Ministry of Health  by IRCT2013022112552N1.Data were collected and analyzed using SPSS Version 16. For the categorical variables, chi-square test or Fisher’s exact test was used . The mean of continuous data were compared between the two groups using Mann-Whitney and ANOVA tests . We also used t-test for comparing the data between two groups as it was necessary . The significance level was defined as a p-value less than 0.05.Two hundred eight cases (case group) and 243 subjects (the control group) were selected. The mean age of the case group was 24.4±5.38 and in the control group was 26.84±5.42 years (P=0.389). Systolic blood pressure was not significantly different until the 45th minute but it turned to be significant later on (P<0.001). Diastolic blood pressure showed a significant difference at the 15th minute and after the 60th minute. Heart rate changes were significantly different between cases and controls at 5, 15 and after 60th minutes (P<0.001) . HemodynNausea vomiting and itching were not significantly different between the two groups. APGAR score was not significantly different between the two groups (P=0.154).In this clinical trial study, the efficacy and complications of intrathecal buprenorphine in elective cesarean section were evaluated. It has been shown that the mean of pain-free period in the study group  was 17.65 hours more than the control group , in which most of these patients did not have any pain during the first 24 hours or the pain was resolved by diclofenac suppository. Other studies showed that adding opioids to local analgesic is an acceptable method to do spinal anesthesia. Prolonged of pain-free period after cesarean section is one of the advantages of spinal anesthesia . The preCandidio et al. reported that adding buprenorphine to a local analgesic could increase the pain- free period three-times in the method of brachial plexus block . In a stHigher doses of intrathecal bupernorphine (0.3-0.9 mg) were associated with low side effects and few more advantages like duration of effect or quality of analgesia. Intrathecal bupernorphine could induce 12-24 hours analgesia. As to compare buprenorphine (0.6 mg) with methadone (20 mg) during hysterectomy, the patients who received buprenorphine requested for less analgesia and had longer pain-free period .th minute and more remarkable in controls which showed the back pain in those who received lidocaine alone.In the present study, changes in heart rate and blood pressure were significantly different between cases and controls after the 60It has been shown that spinal anesthesia for cesarean section is associated with hypotension in mother. Turhanoglu et al. designed a study to evaluate the advantage of intrathecal administration of low dose bupivacaine in cesarean section. They showed that adding bupivacaine (4 mg) to fentanyl (25 mg) did not prevent hypotension but reduced its severity and the dosage needed for treatment by ephedrine . It is aIn the present study, no significant differences were seen between two groups regarding apnea, nausea vomiting and itching. Epidural buprenorphine was used in a study on those with multiple rib fractures and more analgesia and early recovery was reported without significant effects on cardiovascular systems or inducing nausea vomiting and itching .This investigation showed that using intrethecal buprenorphine in cesarean section prolongs the duration of analgesia without any significant changes in hemodynamic status, respiratory problems, side effects like nausea, vomiting and itching.


Management of prescription opioids misuse and abuse problems among chronic pain patients has been increasingly important worldwide and little literature concerning prescription opioids can be found in mainland China so far.The Current Opioid Misuse Measure (COMM) was translated into Chinese following Brislin’s model of cross-culture translation and was completed by a convenience sample of 180 patients with chronic pain recruited from two major hospitals in Jinan, Shandong province. Data were analyzed using internal consistency, test-retest reliability, exploratory factor analysis and confirmatory factor analysis.The internal consistency coefficient for the total score of the COMM was 0.85 and item-total correlations of all items were above 0.20. Besides, the test-retest reliability was satisfactory with an ICC of 0.91 (95 % CI = 0.65-0.98). Four principal components were extracted, accounting for 65.30 % of the variance, and the factor loadings of all 17 items were above 0.40.The Chinese version of COMM showed satisfactory reliability and validity, and could be used as a screening tool to evaluate and monitor current aberrant drug-related behavior among Chinese patients with chronic pain. Opioids, as a potentially effective treatment for chronic pain, have increasingly been prescribed for pain relief among patients with chronic pain in recent years. Despite the benefits of opioid therapy, opioid-related problems are also increasing. In Australia, oxycodone prescriptions increased, particularly among older patients . In the “Misuse” is defined as use of the substance not according to medical indications or prescribed dosing. In addition, misuse is specifically restricted to the prescription or over-the-counter medications, and it occurs only when a drug is taken for medical purpose . At presThe COMM was developed to assess current misuse behaviors for patients with chronic pain who has been on opioid therapy for an extended period of time. Initially, pain management and addiction specialists developed a 40-item alpha COMM using concept mapping, which was then tested in 227 patients taking opioid for chronic, noncancer pain and retested one week later with 55 of them. Meanwhile, all participants finished the Prescription Drug Use Questionnaire (PDUQ) as well as urine drug testing for toxicity screening. Finally, 17 items demonstrated a capacity to measure aberrant behavior with good validity and reliability . The cutoff score of the COMM was 9. Three months later, 86 patients were re-assessed and showed adequate ability of the COMM to track changes over time . FurtherThe aim of this study was to: (1) translate the COMM into Chinese; (2) investigate the reliability and validity of the COMM among Chinese-speaking patients with chronic pain; (3) determine whether the COMM can be used in a Chinese population.Participants were recruited from pain clinics in two major hospitals between July and October 2014 in Jinan city, Shandong Province, China. The inclusion criteria were: (1) age 18 years or older; (2) chronic pain for 3 months or longer; (3) prescription opioid medications for 1 month or longer; and (4) ability to read and speak Chinese with no significant or diagnosed cognitive problems. Ethical approval was obtained from the Research Ethics Committees in Shandong University. In addition, informed consent was obtained from each participant and they had the right to choose whether they would complete the survey independently or have the researcher read the questions and record their responses.The COMM is a validated 17-item instrument, developed by Butler et al. to assess past-month aberrant medication-related behaviors for pain patients taking opioids . A 5-poiDemographic information was obtained from the questionnaire we designed to collect demographic and pain-related information of the participants, including age, sex, education, marital status, pain duration, months of opioid treatment and pain location.Content licensing agreement was obtained from the original authors. The COMM was translated into Chinese, following Brislin’s model , 18. TheThe translated COMM was pilot-tested on a convenience sample of twenty pain patients. After the test, new problems concerning clarity, comprehension and interpretability were discussed. For example, the “road rage” was seldom used in China, many patients had difficulty understanding this phrase, and then we discussed how to express it more clearly and more comprehensible. Finally, the Chinese version COMM was obtained when no substantial disagreements could be found, as is shown in Table A panel of experts was invited to evaluate the content equivalence of the COMM using content validity index (CVI), which is a 4-point rating scale . The CVI is the percentage of agreement of all items rated by the experts as either three or four and an ICC of 0.8 or greater is generally considered to be an indication of good content validity .P < 0.05. For categorical variables, data were presented in forms of frequencies and percentages, and continuous variables were reported as means ± standard deviation (SD).Statistical analyses were conducted using SPSS version 19.0 and Amos version 17.0. Statistical significance was set at The reliability of the COMM was assessed by internal consistency and test-retest reliability. Specifically, the internal consistency reliability was determined by using Cronbach’s alpha coefficients, corrected item-total correlation and inter-item correlation matrix analysis. A Cronbach’s alpha of ≥0.70 and item-total correlation of >0.2 were deemed statistically acceptable . The tesConstruct validity for the COMM was evaluated by principal components analysis with Promax rotation. We first conducted the Kaiser-Meyer-Olkin (KMO) measure and Bartlett’s test to determine if there were a statistically significant correlation among items to perform this analysis . A valueThe 180 chronic pain patients (155 non-cancer and 25 cancer pain patients) had an average age of 55.74 years (SD 16.36), with a range of 18–88 years, and 52.22 % were male. Overall, seventy four patients (41.11 %) had received more than nine years’ education and 155 participants (86.11 %) were married. The average duration of pain was 27.08 months (SD = 52.42), with a range of 3–360 months. The most common primary pain locations were lumbar or sacral pain (38.33 %) and leg pain (35.00 %), as is shown in Table The Cronbach’s alpha and the corrected item-total correlations of all 17 item are shown in Table Moreover, of the 180 participants, 10 were randomly selected to evaluate the teat-retest reliability in two weeks’ interval. The mean scores of the first and second measurements were 13.37 ± 8.15 and 17.80 ± 4.92, respectively. The test-retest reliability was satisfactory with an ICC of 0.91 (95 % CI = 0.65-0.98).For the COMM, all of the 17 items showed a CVI above 0.8, which indicates that the construct validity of the COMM was acceptable.P < 0.001). As shown in Table The construct validity of the COMM was determined by principal components factor analysis with Promax rotation. The result of the KMO measure was 0.78, and the approximate chi-square for Bartlett’s test was 1390.099 , Factor 2 , Factor 3 , and Factor 4 . According to the findings from the CFA, which are shown in Table To our knowledge, this study is the first to apply screening tool of opioid medication to assess aberrant drug-related behaviors in chronic pain patients in Mainland China. Besides, it also provides the first report on the translation and validation of the COMM into Chinese language. The results in this study show good qualities of the COMM in terms of content, interpretability and acceptability. We are able to show feasibility for the use of the Chinese version of COMM to measure misuse behaviors of prescription opioid among patients with chronic pain.The Cronbach’s coefficient alpha of the Chinese version of COMM exceeded 0.70, the general requirements of a questionnaire internal consistency. This value was approximately equal to that of the original English version . The iteThe CVI was excellent, showing that all seventeen items evaluate the same construct as an overall instrument. In the original article of the COMM development, all the 17 items came from five clusters generated during the brainstorming stage, they are: (1) Signs & Symptoms of Drug Misuse (item 1); (2) Emotional Problems/Psychiatric Issues ; (3) Appointment Patterns item 3, 12 and 17); (4) Evidence of Lying and Drug Use ; (5) Medication Misuse & Noncompliance   and 17; .Although, aberrant drug-related behaviors occurring during the process of opioid treatment have increasingly been social and ethical problems for us to deal with, it is important to note that the COMM is not meant to be used punitively, or to deny access to pain relief. It is just one measurement to assess potential opioid misuse for patients on opioid therapy, with the aim of achieving the best opioid treatment effect and then improving the quality of life.There are several limitations in the present study. The researchers in our research team, the funds we got, and the time of conducting this study were all limited, so the sample was recruited only from two major hospitals in Jinan city, Shandong province, in which the pain clinics were ones with relatively larger scale. The two hospitals we chose were both tertiary A hospitals and located in urban area. In addition, all the patients in the present study were not selected randomly, and 65.14 % of them came from cities, the most common primary pain locations were lumbar or sacral and leg pain, accounting for 73.33 %, and codeine, oxycodone, tramadol were more used prescription opioids. Therefore, the findings may not be extrapolated to the general chronic pain patients. Further studies from diverse populations across geographic locations are needed for generalization of the findings to the whole chronic pain patients taking prescription opioid. Moreover, criterion validity of the COMM was not analyzed, since no Chinese version tools, which could be used as proper “criterion” to assess participants' drug misuse behaviors, could be found. However, other methods including UDT and psychosocial screening interviews, could be used as references in combination with the Chinese version of COMM to evaluate its predictive and diagnostic capabilities in further studies. Besides, because limitations of time, financial and human resources, the sample size for a test-retest reliability testing was quite small, and the sample size for the CFA is not big as well. Further research should recruit a much larger sample to verify our research findings. Last but not least, other screening tools for aberrant drug-related behaviors, either self-report or physician rated, such as the pain medication questionnaire (PMQ), screener and opioid assessment for patients with pain (SOAPP), opioid risk tool (ORT), prescription drug use questionnaire (PDUQ) and pain assessment and documentation tool (PADT) , 25, shoIn conclusion, this is the first attempt to translate and validate the COMM in a non-English-speaking country. As reported in this study, the Chinese version of COMM demonstrated relatively high level of reliability and validity among Chinese patients with chronic pain. This self-report measure could evaluate and monitor current aberrant drug-related behavior as a screening tool among Chinese patients with chronic pain-prescribed opioids.


Individuals far from treatment centres are at increased risk of unmet needs. Given the high prevalence of headache, this is a great concern. With increased communication technology advancements including telehealth comes the opportunity to treat remote patients with limited or no access.1) To compare the efficacy of the Pain 101 program in headache patients who attend the program in person versus those who attend via telehealth.2) To discuss qualitative aspects of telehealth use reported by patients and staff.Adolescent and adult outpatients with complex headaches referred to tertiary care hospitals were enrolled in Pain 101. This pain management program targets pain education, reducing physiological arousal, goal setting and activity management, cognitive reappraisal and acceptance, and emotional regulation.Adult and pediatric patients showed significant and lasting reductions in pain, pain-related disability, anxiety, pain-related fear, and a significant improvement in sleep and quality of life. Adults but not pediatric patients showed depression reduction. No significant differences were found between patients who attended via telehealth compared to those attending in person. Cost saving estimates to individual patients ranged from 1650–6600 Euro. Qualitatively, several patients reported that they would not have been able to attend without telehealth. Common complaints regarding telehealth were occasional technical difficulties and not feeling as involved in the group process.Strong support for telehealth technology was found for individuals with complex headaches who live far from treatment centres. Recommendations for effective use of this technology for providing headache treatment will be discussed.No conflict of interest.


Epidural analgesia is considered the standard of care but cannot be provided to all patients Liposomal bupivacaine has been approved for field blocks such as transversus abdominis plane (TAP) blocks but has not been clinically compared against other modalities. In this retrospective propensity matched cohort study we thus tested the primary hypothesis that TAP infiltration are noninferior (not worse) to continuous epidural analgesia and superior (better) to intravenous opioid analgesia in patients recovering from major lower abdominal surgery. 318 patients were propensity matched on 18 potential factors among three groups (106 per group): 1) TAP infiltration with bupivacaine liposome; 2) continuous Epidural analgesia with plain bupivacaine; and; 3) intravenous patient-controlled analgesia (IV PCA). We claimed TAP noninferior (not worse) over Epidural if TAP was noninferior (not worse) on total morphine-equivalent opioid and time-weighted average pain score  within first 72 hours after surgery with noninferiority deltas of 1  for pain and an increase less of 20% in the mean morphine equivalent opioid consumption. We claimed TAP or Epidural groups superior (better) over IV PCA if TAP or Epidural was superior on opioid consumption and at least noninferior on pain outcome. Multivariable linear regressions within the propensity-matched cohorts were used to model total morphine-equivalent opioid dose and time-weighted average pain score within first 72 hours after surgery; joint hypothesis framework was used for formal testing. TAP infiltration were noninferior to Epidural on both primary outcomes (p<0.001). TAP infiltration were noninferior to IV PCA on pain scores (p = 0.001) but we did not find superiority on opioid consumption (p = 0.37). We did not find noninferiority of Epidural over IV PCA on pain scores (P = 0.13) and nor did we find superiority on opioid consumption (P = 0.98). TAP infiltration with liposomal bupivacaine and continuous epidural analgesia were similar in terms of pain and opioid consumption, and not worse in pain compared with IV PCA. TAP infiltrations might be a reasonable alternative to epidural analgesia in abdominal surgical patients. A large randomized trial comparing these techniques is justified. Pain management after major abdominal surgery remains challenging. The best-accepted analgesic approach is continuous epidural analgesia which is generally thought to be considerably more effective than intravenous patient-controlled opioid analgesia (IV PCA) , 2. HoweThe Transversus Abdominis Plane (TAP) infiltration is an alternative approach to providing postoperative analgesia to the anterior abdominal wall . TAP infIt would be attractive if single-shot TAP infiltration with liposomal bupivacaine were as effective as continuous epidural analgesia. We, therefore, tested the primary hypothesis that TAP infiltration with single-shot liposomal bupivacaine is noninferior (not worse) to continuous epidural analgesia in patients recovering from major lower abdominal surgery. Secondarily, we tested the hypotheses that both TAP infiltration and epidural analgesia provide better postoperative analgesia than IV PCA. We also evaluated the association between analgesic strategy and hospital length-of-stay, postoperative paralytic ileus, steroid administration, non-steroidal anti-inflammatory (NSAID) and antiemetic medication use, and time to first rescue opioid postoperatively.With approval of the Cleveland Clinic Research Advisory Committee of Anesthesiology Institute (07/16/2014) and the Cleveland Clinic Institutional Review Board , we obtained data on major  lower-abThe Cleveland Clinic Perioperative Health Documentation System contains information about all patients who have non-cardiac surgery since May of 2005 at Cleveland Clinic’s main campus and since August 2013 at Cleveland Clinic Fairview campus. It integrates preoperative variables , intraoperative variables (via the Anesthesia Record Keeping system) and postoperative outcomes (by linking to the Cleveland Clinic billing data systems).Demographic and baseline data obtained from the registry were augmented by manually-encoded additional postoperative medication data obtained from eligible patients’ electronic medical records.We considered three primary postoperative analgesic strategies after lower abdominal surgery under general anesthesia. (1) TAP infiltration: a bilateral TAP infiltration was performed preoperatively, and a total of 40 mL solution was injected, consisting of 20 mL (5 mg/mL) bupivacaine and 20 mL (13.3 mg/mL) liposomal bupivacaine . (2) Epidural analgesia: an epidural catheter was inserted preoperatively and mainly started intraoperatively. The epidural solution contained fentanyl 2 mcg/mL and bupivacaine 0.1%, and was given at a basal rate of 5–7 mL/hour, with demand boluses of 6 mL and lockout interval time of 15 minutes. (3) IV PCA: patients were given IV PCA with hydromorphone 0.5 mg/mL, fentanyl 20 mcg/mL, or morphine 1 mg/mL. The rescue analgesia was given as per hospital policy in all the three groups (ordered by clinicians if pain score (NRS) ≥ 4) and included opioids, NSAID medication. Following the emergence administration of the first analgesic medication was counted as a first rescue analgesic. If rescue analgesia included opioid medication it was reflected in the outcome ‘Total opioid IV morphine equivalent dose until 72 hours’. All rescue medications including times, dates, pre and post administration pain score documentation are in electronic medical record (EPIC). TAP and Epidural groups were also given supplemental IV PCA with similar settings for postoperative pain management.Our two primary outcomes were total postoperative intravenous (IV) morphine-equivalent dose of opioid and time-weighted average numeric rating scale (NRS) pain scores. Both were evaluated over 72 postoperative hours or until hospital discharge, whichever came first. All procedures were performed by anesthesiologist. Postoperative pain management, follow up completed by acute pain service and surgical team. Post-anesthesia care unit and floor nurses were assessed and recorded 10 point numeric rating pain scores. NRS pain scores were obtained by nurses, per routine, roughly every four hours. Postoperative opioid medications were obtained from electronic medical records and were converted into IV morphine-equivalent doses using the opioid conversion rates from Sex, race, American Society of Anesthesiologists (ASA) Physical Status, history of diabetes, chronic pain syndrome, history of chronic opioid use, preoperative steroid and statins use, year of surgery, elective or emergency surgical status, type of the surgery, surgical approach (open vs. laparoscopic procedure), intraoperative administration of opioids, nonsteroidal anti-inflammatory drugs (NSAID), and steroid were considered for confounding adjustment and coded as categorical or binary variables. Age, body mass index, and duration of surgery were also considered for confounding adjustment, and coded as continuous variables.Patients receiving TAP infiltration were matched to patients receiving Epidural and patients receiving only IV PCA patients in a 1:1:1 ratio based on propensity scores . PropensTriplets of propensity-matched patients were obtained by a three-step procedure. First, each patient who received TAP infiltration was matched to an Epidural patient. Then, each patient who received TAP infiltration was again matched, this time to a patient who received IV PCA. Finally, a filter was applied to include only those TAP infiltration patients who were successfully match to both an Epidural patient and IV PCA only patient thus resulting in the matched triplets. Matching was limited to pairs within 0.2 standard deviations of the propensity score logits  of one another .Successfully matched triplets were restricted to those for which all three patients had common type of lower abdominal surgery , all three surgeries were either open or laparoscopic and occurred with one year of each other. All subsequent analyses were restricted this subset of matched patients. Potential confounding variables remaining imbalanced after matching (if difference between variables significant at the 0.05 significance level) were used for adjustment in all subsequent analyses.SAS statistical software version 9.3  for 64-bit Microsoft Windows and R statistical software version 2.15.2 for 64-bit Unix operating system  were used for all statistical analyses.We assessed the relative effect of the three treatment groups on postoperative pain and opioid consumption using a joint hypothesis testing framework as described in Mascha and Turan . Based oMultivariable linear regression was used to model opioid consumption and pain score within the propensity-matched cohort of patients; opioid consumption was log-transformed during the modeling process. Therefore, we assessed noninferiority on opioid consumption based on the exponentiated difference in means on the log scale . Thus for opioid consumption, we tested the alternative hypothesis that the ratio of geometric means that there was less than 20% increase in opioid consumption with TAP infiltration than Epidural analgesia, and vice versa. For pain, we tested the alternative hypothesis that mean pain score for TAP infiltration was less than 1 point greater than with Epidural, and vice versa.Lastly, we compared each of TAP infiltration and Epidural to IV PCA patients on total postoperative opioid consumption and pain score within first 72 hours of the surgery or until discharge. TAP infiltration or Epidural would be considered preferable to IV PCA if found superior on opioid consumption and at least noninferior on pain score (with noninferiority delta of 1). All tests were one-tailed.Our primary hypothesis was assessed in a joint hypothesis testing framework which controlled the type I error at 0.025  across all noninferiority and superiority testing  comparinThe average pain scores for three matched groups over first 72 hours after surgery were summarized graphically with loess regression curve  .To address reviewer’s concerns the sensitivity analysis was performed analogous to the primary, except excluding OB/GYN, laparoscopic and emergency surgeries as well as patients with history of opioid use from the matched cohort.Patients who did not receive any rescue opioid within 72 hours of the surgery or had incomplete time to first rescue opioid administration were censored at 72 hours after surgery or at hospital discharge. The association between pain management strategies and time to first rescue opioid administration was assessed with a Cox proportional hazards model that accounts for censoring. Four separate logistic regression models were developed to model associations between study groups and each of postoperative paralytic ileus and NSAID, steroid use, and antiemetic administration.We also assessed the association between pain management strategies and duration of postoperative hospitalization. A linear model was used with log-transformed duration of postoperative hospitalization  as an outcome and pain management strategies as a predictor.We compared the three study groups on each secondary outcome using an appropriate 2-tailed model-based Wald test. The significance level for the set of secondary outcomes were preserved at 0.05 overall by using a significance criterion of P < 0.05/6/3 = 0.0028 for each test (applying Bonferroni correction for three pairwise comparisons on each of six secondary outcomes).Power analysis was based on the analysis of noninferiority on opioid consumption because this analysis required more patients than analysis on pain scores.We included all available TAP infiltration patients in our analysis. After matching, there were 106 patients per group for a total of 318 patients. This sample size provided 98% power at the 0.0625 significance level to detect noninferiority of TAP infiltration to Epidural on opioid consumption assuming a noninferiority delta of ratio of means of 1.2 for opioids (less 20% increase in opioids), true ratio of means of 0.6 and a coefficient of variation (CV = SD/mean before log-transformation) of 1.5.Our query of the Perioperative Health Documentation System revealed 14,857 major lower-abdominal surgeries on adults and after eliminating patients with missing baseline measurements, and repeated procedures, 11,976 patients remained, including 122 (1%) who received TAP infiltration and, 800 (7%) who received epidural, and 11,054 (92%) who received IV PCA .Based on demographic and baseline characteristics, we successfully 1:1:1 matched a total of 318 patients with 106 patients per group. We thus included 87% of 122 TAP infiltration patients. The TAP infiltration group was noninferior (not worse) to Epidural on both outcomes .TAP infiltration with liposomal bupivacaine was non-inferior to epidural catheters for both pain and opioid consumption. This is a curious result since TAP infiltration provide coverage for somatic pain only , while eThere have been only a few comparisons between TAP infiltration and epidural analgesia. Kadam et al, in a retrospective review, compared TAP and thoracic epidural catheter  and NiraIn distinct contrast to our expectations, neither TAP infiltration nor epidural analgesia proved superior to IV PCA on opioid consumption. Furthermore, epidural analgesia was noninferior to opioid group on pain scores. A possible explanation is that the epidural solution used in our institution contains a substantial amount of opioid (2 mcg/ml of fentanyl) which was included in the total opioid consumption. And as mentioned above, TAP infiltration does not prevent the visceral component of abdominal pain which probably prompted some opioid use by patients—thus compromising our ability to demonstrate superiority. And finally, either approach can produce uneven coverage or patchy infiltration which will prompt patients to use intravenous opioids and making it difficult to demonstrate the superiority.Opioid-related side effects including ileus and postoperative nausea and vomiting were similar, presumably because opioid consumption was similar. NSAID and steroid drugs are usually scheduled, rather than provided per patient request, making it difficult to demonstrate a difference in a retrospective study.Existing literature on epidural analgesia and hospital length-of-stay are inconsistent , 22. PreAs with any all-retrospective studies, our ability to adjust for potential confounding is limited to available data. Although we accounted for potential confounding effects of eighteen patient and surgical factors, residual bias due to uncontrolled confounding variables remains possible. For example, anesthesiologists may have preferred epidural catheter placement in sicker patients, scheduled longer surgery, or having longer surgical incisions—thus selecting patients likely to stay longer in the hospital. We were unable to evaluate postoperative ambulation, but patients with epidural analgesia are likely to be less mobile than the other groups which may have prolonged the duration of hospitalization while possibly reducing pain scores and opioid consumption. In our database only 10 point numeric rating pain scores were recorded, have no detailed data for pain measurement i.e the American Pain Society Patient Outcomes Questionnaire-revision 1 and Pain Out have established validated tools for analyzing somatic and psychosocial components of pain. Potential residual bias limits our ability to make causal conclusions, which are most reliably derived from randomized trials. Consequently, the associations we report should not be considered evidence of a causal relationship.TAP infiltration and epidural analgesia did not differ in pain and opioid consumption and did not have worse pain scores than IV PCA after abdominal surgery. Our retrospective analysis suggests that TAP infiltration with liposomal bupivacaine is a reasonable alternative to epidural analgesia, and to IV PCA. A large randomized trial comparing these techniques is justified.


Lumbar disc herniation (LDH) is a common indication for lumbar spine surgery. The proportion of patients having a second surgery within 2 years varies in the literature between 0.5% and 24%, with recurrent herniation being the most common cause. Several studies have not found any relevant outcome differences between patients undergoing surgery for primary LDH and patients undergoing reoperation for a recurrent LDH, but these studies have limitations, including small sample size and retrospective design.We (1) compared patient-reported outcomes between patients operated on for primary LDH and patients reoperated on for recurrent LDH within 1 year after index surgery and (2) determined risk factors for worse outcomes.We obtained data from the Swedish National Spine Register, Swespine, where patient-reported outcomes are collected using mailed protocols at 1, 2, 5, and 10 years after surgery. Of the 13,562 patients identified who underwent LDH between January 2000 and May 2011, 13,305 (98%) underwent primary surgery for LDH and 257 (2%) underwent reoperation for a recurrent LDH within the first year. Patient-reported outcomes at 1 to 2 years were available for 8497 patients (63%), 8350 of 13,305 (63%) in the primary LDH group and 147 of 257 (57%) in the recurrent LDH group (p = 0.068). We compared leg and back pain (VAS: 0–100), function (Oswestry Disability Index [ODI]: 0–100), quality of life (EQ-5D: −0.59 to 1.0), patient satisfaction, and global assessment of leg pain between groups. We also analyzed rsik factors for worse global assessment and satisfaction.Mean (95% CI) differences in improvement between groups favoring patients with primary LDH were VAS leg pain 9 (4–14), ODI 6 (3–9), and EQ-5D 0.09 (0.04–0.15). While statistically significant, these effect sizes may be lower than the minimal clinically important differences often referred to. Percentage of satisfied patients was 79% and 58% in the primary and recurrent LDH groups, respectively (p < 0.001), and percentage of patients with no or better leg pain  was 74% and 65%, respectively (p = 0.008). Reoperation for recurrent LDH represented the largest independent risk for dissatisfaction; this factor and smoking represented similar risks for less improvement in leg pain.Repeat surgery for a recurrent LDH was performed with good probability for improvement, although not as good as for primary LDH surgery, and patients undergoing repeated surgery were less satisfied. Studies on risk factors for recurrence are warranted.Level II, therapeutic study. See Instructions for Authors for a complete description of levels of evidence. Lumbar disc herniation (LDH) is one of the most common indications for lumbar spine surgery , 12, 19,Several studies comparing outcome after surgery for LDH have not found any relevant differences between primary and revision surgery , 16, 20.Using data from the Swedish National Spine Register, Swespine, we therefore compared patients who underwent surgery for primary LDH and patients reoperated on for recurrent LDH within 1 year after the primary operation in regard to patient-reported outcomes, including pain (VAS score), function (Oswestry Disability Index [ODI]), and quality of life (EQ-5D). We also compared patient satisfaction and global assessment with regard to leg pain between groups and investigated whether there were any factors for being less satisfied and experiencing worse global assessment with regard to leg pain.Swespine was initiated in 1993, and today approximately 80% of the total number of surgical procedures for LDH in Sweden is included in the register on a yearly basis , 19. AppThe current protocol of the register, which has been validated in a test-retest situation, can reliably detect postoperative improvements between large groups of patients such as those in a registry , 24. PatThe followup questionnaires are sent to the patient’s home with a prepaid and addressed return envelope. Preoperative data completed by the patient include for example age, sex, and smoking habits.The patient-reported outcomes used in this study were leg pain on a VAS scale , functional status using the ODI , and quality of life using the EQ-5D  . Ordinal scale questions regarding patient satisfaction and global assessment of change in leg pain were also included. Options for satisfaction included satisfied, uncertain, and dissatisfied; options for global assessment of leg pain included pain free, much better, somewhat better, unchanged, or worse. For analysis, the answers were dichotomized as “satisfied” versus “uncertain or dissatisfied” for patient satisfaction and “completely gone or much better” versus “somewhat better, unchanged, or worse” for global assessment of leg pain. The global assessment instrument has been validated against other outcome measures [Data were obtained for all patients reported in Swespine who underwent surgery for LDH between January 1, 2000, and April 30, 2011. Baseline data collected at the time for the primary operation (index procedure) were used for comparison at followup, meaning no new baseline data were collected before a reoperation, which is standard procedure in Swespine. We analyzed patient-reported outcomes collected 2 years after the primary operation (index procedure) for all patients. We used the 2-year followup time point after the primary operations in all patients to include at least a 1-year followup for those patients reoperated on close to 1 year after the primary operation. Since we have demonstrated that outcomes measured 1 and 2 years after LDH surgery are similar , we do nIn all, 13,562 patients who underwent surgery for an LDH due to radiating pain and neurologic symptoms resistant to nonoperative treatment were included in the analyses  completed the followup. There was a comparable proportion of responders in the primary LDH group  and the recurrent LDH group  (p = 0.068). Loss to followup was separately analyzed in the primary and recurrent LDH groups with regard to baseline variables. In the primary LDH group, the nonresponders were more often female (p < 0.001), were slightly younger (p < 0.001), and reported a higher frequency of smoking (p < 0.001) compared to the responders; they also reported slightly less leg pain (p < 0.001) at inclusion. However, there were no differences between responders and nonresponders with regard to back pain (p = 0.195), ODI (p = 0.969), and EQ-5D (p = 0.054). In the recurrent LDH group, male sex was more common among patients lost to followup (p = 0.026). However, there were no differences between responders and nonresponders with regard to smoking (p = 0.506), age (p = 0.120), or baseline values for VAS leg pain (p = 0.620), back pain (p = 0.620), function ODI (p = 0.767), or EQ-5D (p = 0.794). We consider the statistically significant differences between responders and nonresponders to be of minor importance from a clinical perspective.For the VAS, ODI, and EQ-5D scores, we used the difference between preoperative (primary operation) and followup values as a measure of improvement. Baseline characteristics between the groups were compared using the independent T-test for continuous data. The chi-square test was used for ordinal data . In the outcome calculations, the continuous variables were analyzed in a mulivariate fashion using the analysis of covariance test, with adjustment for sex, smoking, age at baseline, and baseline value of the analyzed variable. After dichotomization of patient satisfaction and global assessment into binary variables, adjusted logistic regression was used to express odds ratios with 95% CIs. The models were adjusted for sex, smoking, and age. In multivariate analysis, it is important to use limited numbers of relevant regressors. In large observational studies, multiple regression often restricts the number of patients possible to include in the statistical analysis. We considered age, sex, and smoking as the most important confounders in this study, although residual confounding remained.Patients undergoing primary surgery for LDH experienced greater improvement than patients having revision surgery for a recurrent LDH within the first year after the primary operation in terms of leg and back pain , and the proportion of patients with no leg pain or better leg pain was 74% and 65%, respectively (p = 0.008) Table . Using tLDH is a common indication for lumbar spine surgery. The proportion of patients having a second surgical procedure within 1 or 2 years varies between 0.5% and 24% in the literature  with recThis study has limitations and should be interpreted in light of these. First, in terms of followup, of the 13,562 patients included in the registry, 8497 (63%) responded after 2 years and were thus available for analyses, 8350 in the primary LDH group and 147 in the recurrent LDH group. The patient response rates was 63% and 57% in the primary and recurrent LDH groups, respectively; the difference of 6% was not significant (p = 0.068), but this should nevertheless be kept in mind. Second, there were differences in baseline variables; although the large sample size resulted in some of these being statistically significant, these differences did not reach what is considered to be relevant clinical values. Also, although there were a few baseline differences between the responders and nonresponders within the two groups and although we regard the low response rate as an issue, we still believe our results are valid.Another limitation pertains to the effect sizes and the literature-derived minimal clinically important differences. While we found statistical differences between the study groups in some outcome measures, it is our impression from what we have reviewed in the literature that these differences are not clinically important as they did not reach reported minimally important clinical difference values, which have been reported to be about 15 to 20 of 100 for VAS , 15, 10 While not a limitation per se, the question often arises about the relationship between registry data and other research designs, such as the randomized, controlled trial, in which baseline confounders may be neutralized in a way that makes it possible to draw specific conclusions about different treatment strategies. We believe these designs are complementary, in that randomized controlled trials offer strong internal validity, but registry data may be superior in terms of external validity  , 14. In Our results contrast somewhat from what was reported by Ahsan et al. . They inCompared with our study, these earlier studies had different criteria for inclusion, followup periods, approaches, surgical treatments, outcome measurements, sample sizes, and numbers of surgeons, clinics, and patients. This may help explain the differences between their results and ours, where we found that patients on a group level had better outcome if they were not reoperated for a recurrent LDH within 1 year after the primary operation.Interestingly, although we believe that the differences in reported outcomes with regard to leg pain (VAS), function (ODI), and quality of life (EQ-5D) are close to or below the reported minimally clinically important differences for these scores, patients were more likely to not be satisfied (odds ratio = 2.56) and have less improvement in global assessment of leg pain (odds ratio = 1.48) if they had undergone an operation for a recurrent LDH. To experience a reoperation is probably psychologically negative, which could explain the difference between patient satisfaction and 1-year patient-reported outcomes in regard to pain, function, and quality of life. While patient satisfaction is considered to be a relevant measure in patient-centered care, we find it interesting that the correlation between satisfaction and other outcome measures such as VAS, ODI, and EQ-5D has been demonstrated to be poor , and it www.ichom.org) and with current participation of approximately 20 countries on a global scale. Results from these comparisons will hopefully facilitate benchmarking and increase our possibilities to improve spine surgery faster to the benefit of our patients.We found that repeat surgery for a recurrent LDH can be performed with a high likelihood of clinical improvement, although not as high as for primary LDH surgery, and patients undergoing reoperation were less satisfied with their result. Future studies on risk factors for recurrence are warranted. We believe that registers measuring patient-reported outcomes should be using an internationally agreed on “core data set” with relevant followup periods. Such a set, basically built on patient-reported outcome measures, has been launched recently (November 2013) for low-back pain with the International Consortium of Health Outcome Measurements as coordinator (


Patients with a proximal femur fracture are often difficult to evacuate from the accident scene. Prehospital pain management for this vulnerable group of patients may be challenging. Multiple co-morbidities, polypharmacy and increased age may limit the choice of suitable analgesics. The fascia iliaca compartment (FIC) block may be an alternative to intravenous analgesics. However this peripheral nerve block is mainly applied by physicians.In the Netherlands, prehospital emergency care is mostly provided by EMS-nurses. Therefore we examined whether well-trained EMS-nurses are able to successfully perform a FIC block in order to ensure timely and appropriate effective analgesia.The study was study was registered in the Netherlands Trial Register (NTR-nr 3824).Ten EMS nurses were educated in the performance of a FIC-block. Indications, technique, side-effects and complications were discussed. Hereafter the trained EMS-nurses staffed ambulance teams were dispatched to patients with a suspicion for a proximal femur fracture. After confirmation of the diagnosis, the block was performed and 0.3 ml/kg lidocaine (10 mg/ml) with adrenaline 5 μg/ml was injected. The quality of pain relief, occurrence of complications and patient satisfaction were evaluated.In 108 patients a block was performed. One hundred patients could be included. Every EMS nurse performed at least 10 FIC blocks. The block was effective in 96 patients. The initial median (NRS)-pain score decreased after block performance to a score of 6 (after 10 minutes), 4 (after 20 minutes) and 3 (after 30 minutes). At arrival at the Emergency Department the median pain score was 3. Dynamic NRS-pain scores when transferring the patient from the accident scene to the ambulance stretcher, during transportation to the hospital and when transferring the patient to a hospital bed were, 4, 3 and 3.5 respectively. Patient satisfaction was very high. No complications were noted.Additional educated EMS-nurses are able to successfully perform a FIC-block for providing acute pain relief to patients with a suspected proximal femur fracture. Emergency medical services (EMS) nurses providing emergency care are frequently confronted with patients suspected with proximal femur fractures (PFF). In people older than 70 years the incidence is approximately 0.5% and due to the ageing population a rise in hospital admissions for suspected proximal femur fractures will be expected .After a fall, these elderly people with PFF’s may be difficult to evacuate and often multiple painful transfers are necessary  before a definite diagnosis can be made. Prehospital pain management for this vulnerable group may be challenging. Multiple co-morbidities and polypharmacy may limit the choice of suitable analgesics. The cognitive impairment, either as a result of dementia or acute confusion as a result of the injury may contribute to inadequate administration of analgesia of analgesic drug . Almost The administration of a fascia iliaca compartment (FIC) or femoral nerve block is a safe alternative and has demonstrable benefits to intravenous analgesics .A number of studies support the use of femoral nerve or fascia iliaca compartment block for pain relief in the emergency department after femur fractures -7. This Also in prehospital emergency care this nerve block has been successfully applied by physician staffed emergency teams -12.In the Netherlands prehospital emergency care is mostly provided by EMS-nurses. Therefore we examined whether well-trained EMS-nurses are able to successfully perform a fascia iliaca compartment block, in order to ensure timely and appropriate effective analgesia, as evaluated by a decrease in NRS-score with a least two points, to all patients with a suspected proximal femur fracture.Ten EMS-nurses were trained in the performance of a FIC-block. A theoretical training in anatomy, pharmacology of local anesthetics, recognition and treatment of complications and the technical performance of the block was provided. Hereafter the performance of the block was exercised on human cadavers.At the end of the training a theoretical exam was taken. Then the nurses had to demonstrate and simulate the performance of the FIC-block on a volunteer. The theoretical needle insertion site was verified by ultrasonography.After successful passing these tests the nurses were considered to be proficient and were authorized by the medical director of the ambulance service to perform the FIC-blocks in order to allocate the right EMS-nurse staffed emergency team to a patients with a suspected proximal femur fracture and to avoid treatment delays, the regional emergency dispatch centre Brabant Zuid-Oost in Eindhoven was also educated in the inclusion and exclusion criteria for patients participating in this study.Inclusion criteria consisted of age older than 18 years, suspicion of a non-complicated proximal femur fracture, and an unacceptable Numeric Rating Scale (NRS) pain score of four or more. .2, severe distracting injuries, or allergy for local anesthetics.Exclusion criteria were decreased conscious level, disorientation for time place and person, hemodynamic instability which was defined as a heart rate lower than 60 or higher than 100 and a systolic blood pressure lower than 90 mmHg, neurovascular damage symptoms, signs of infection at the needle insertion site, impossibility to palpate the femoral artery, Body Mass Index (BMI) higher than 30 kg/mAfter arrival at the scene, the EMS-nurses took a short history. If shortening and exorotation of the affected leg and severe pain in the inguinal or hip region were present on physical examination; then a proximal femur fracture was suspected and a pain (NRS) score was determined and noted.Intravenous access was obtained and standard monitoring  was applied.The procedure was explained to the patient. The single injection FIC block was performed as described by Dalens et al. . The pubFrom a prefilled flacon 0.3 ml/kg lidocaine (10 mg/ml) with adrenaline 5 μg/ml was drawn up in 10 ml syringes.The skin was cleaned with chorhexidine and under a 70° angle to the skin, the 18-G Tuohy needle  was inserted. Two clearly identifiable loss of resistances (clicks or plops) had to be felt while crossing the fascia lata and fascia iliaca. After negative aspiration for blood the local anesthetic was slowly over 2 mins) injected after repeated aspiration  such as tingling around the mouth, light headedness, visual disturbances, seizures or arrhythmias. If one of these symptoms occurred, the injection was stopped and oxygen administered. Pain treatment was provided by iv analgesics. Signs of LAST were noted as a complication.The following data were collected; demographic data, weight of the patient, the ease of the block procedure .NRS pain scores at arrival at the scene and after 10, 20 and 30 minutes after the performance of the block and at arrival at the Emergency Department of the receiving hospital were obtained.Also dynamic pain scores (pain scores during manipulation of movement) were noted after movement to the ambulance stretcher, during ambulance transporting and when transferring from ambulance stretcher to the hospital bed.In the cutaneous distribution of the femoral nerve, sensibility was tested at the medial mid-femoral and medial site of the lower limb, using cold alcohol swabs.A FIC-block was considered successful if the NRS-pain score decreased with at least two points.If 30 minutes after block performance the patient considered the pain as unacceptable and the NRS pain score had not decreased to three or lower, than the (nationwide) Dutch Ambulance protocol (LPA 7.2) was followed and fentanyl 2 μg/kg was injected intravenously. If needed every three minutes an additional dose of 0.5 μg/kg fentanyl was given until acceptable pain scores or NRS score lower than four was reached. The need for additional analgesics was noted.In order to obtain informed consent all patients were visited during their hospital stay. During this visit they were also asked about their satisfaction with the provided pain relief before admission in the hospital. The patient satisfaction score was noted .Neurological complications were noted after reviewing the medical record.Descriptive statistics were used to describe and summarize the data obtained in this study. Demographic data are presented as mean (standard deviation). NRS pain scores are presented as median (first quartile – third quartile). Calculations were made with Microsoft Office Excel 2007 .The Medical Ethics Committee of Arnhem-Nijmegen approved a waiver of informed consent for performing the FIC block but written informed consent was obtained for the use of the documented data. The study was registered in the Netherlands Trial Register which is equivalent to the ClinicalTrials.gov registry (NTR-nr 3824). Progress of the study and safety of the patients was reviewed by an independent Data Safety Monitoring Board.Patients were included between November 1, 2012 and December 1, 2013. The regional emergency dispatch centre allocated 110 times the trained EMS-nurses to a patient with a suspected proximal femur fracture. At arrival two times no fracture was suspected. In 108 patients a fascia iliaca compartment block was performed. However six patients were not able to give informed consent due to postoperative confusion and two due to severe postoperative complications. So 100 FIC-block procedures could be included in this study.In 80 women and 20 men a block was performed. The mean age of the patients was 81 years. SD = 9.4) and the mean BMI was 24 SD = 3.8).Median (at rest) NRS pain scores at arrival decreased, 10, 20 and 30 minutes after FIC-block performance . At arrival in the ED, 75% had a NRS-pain score of four or lower. Loss of sensibility in the femoral nerve distribution was detected in 88% of the patients. Patients were satisfied with the provided pain relief and the median satisfaction score was nine. No complications were observed. Seven patients complained about nausea during transportation.In 93 patients the suspected diagnosis of proximal femur fracture PFF was confirmed after physical and X-ray examination by a physician.The other seven patients were diagnosed with contusion of the hip and the FIC block was successful in six of them.This study demonstrates that trained nurses can succesfully perform a FIC block in patients with a suspected proximal femur fracture. The block was successful in 96%. The relative high successrate may be the result of our definition of block success, but if we would have defined block success as a decrease in NRS-pain score with more than three points the success was still 90%. At arrival in the ED, 75% of the patients had a pain score of four or lower. This is slightly better than previously reported results (70%) of a femoral nerve block performed by nurses in the ED . In anotRegional anesthestic procedures are significantly more difficult to learn than manual skills necessary for providing general anesthesia. Learning manual skills depends on many variables. Besides differences in individual sensorimotor skills of the operator, the exposure to a sufficient number of cases influences the learning skills . Our ineFor providing acute pain relief to trauma patients, the use of peripheral nerve blocks has advantages over the present technique of administering opioids, or midazolam and ketamine. The risk of respiratory complications, sedation, nausea and vomiting is lower. Moreover nerve blocks may provide longer lasting analgesia ,15. HoweThe FIC-block is a peripheral nerve block which was described by Dalens in 1989 . It has The FIC block based on external anatomical landmarks is an easy and relative safe block. Besides a needle, syringe and local anesthetic no other equipment is necessary. The needle insertion site is located in some distance from the femoral artery and nerve which minimizes the risk on intravascular injection nd neurological injury. Complications as nerve damage and intravascular injection are seldom described .Recently ultrasonography has also been used for the performance of this nerve block ,19. HoweCompared to other local anesthetics, lidocaine is one of the safest local anesthetics. It was injected in a dose of 3.0 mg/kg, this is only half of the recommended maximal dose described (6 mg/kg) . LidocaiAn advantage of administering short acting local anesthetic for pain relief is that the block quickly wears off and this allows early mobilisation in case no surgical intervention is necessary.In patients with a proximal femur fracture, hip flexion is limited to 15 degrees. However after a succesful FIC-block due to analgesia and relaxation of the quadricpes muscle, hip flexion increases to 53 degrees . This alA limitation of this study is that the effectiveness of the block is not tested by an independent observer. However for practical and logistical reasons it was not possible to add 10 observers to 10 solely working ambulance teams. Moreover the study is not powered to draw any conclusions on the incidence of complications which may occur during or after the performance of a FIC-block by paramedics.In conclusion this study demonstrates that educated EMS-nurses can effectively perform FIC-blocks for acute pain relief in patients with a suspected proximal femur fracture. Further research may reveal whether this method of pain relief may lead to less complications than the present methods for providing acute pain relief.The authors declare that they have no competing interests.ED contributed to the design of the study, educated the EMS-nurses and was responsible for acquisition of data and monitoring the study. GJvG designed the study, educated the EMS-nurses, reviewed and interpreted the data and drafted the manuscript. JB and NH contributed to the design of the study, reviewed and interpreted the data and contributed in writing the manuscript. HP and GJS reviewed and interpreted the data and revised the manuscript. All authors have given final approval of this manuscript for publishing and agree to be accountable for all aspects of this work.