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Femoral nerve block Intervention in Neck of Femur fracture (FINOF): study protocol for a randomized controlled trial.

ABSTRACT: Hip fractures are very painful leading to lengthy hospital stays. Conventional methods of treating pain are limited. Non-steroidal anti-inflammatories are relatively contraindicated and opioids have significant side effects.Regional anaesthesia holds promise but results from these techniques are inconsistent. Trials to date have been inconclusive with regard to which blocks to use and for how long. Interpatient variability remains a problem.This is a single centre study conducted at Queen's Medical Centre, Nottingham; a large regional trauma centre in England. It is a pragmatic, parallel arm, randomized controlled trial. Sample size will be 150 participants (75 in each group). Randomization will be web-based, using computer generated concealed tables (service provided by Nottingham University Clinical Trials Unit). There is no blinding. Intervention will be a femoral nerve block (0.5 mls/kg 0.25% levo-bupivacaine) followed by ropivacaine (0.2% 5 ml/hr-1) infused via a femoral nerve catheter until 48 hours post-surgery. The control group will receive standard care. Participants will be aged over 70 years, cognitively intact (abbreviated mental score of seven or more), able to provide informed consent, and admitted directly through the Emergency Department from their place of residence. Primary outcomes will be cumulative ambulation score (from day 1 to 3 postoperatively) and cumulative dynamic pain scores (day 1 to 3 postoperatively). Secondary outcomes will be cumulative dynamic pain score preoperatively, cumulative side effects, cumulative calorific and protein intake, EUROQOL EQ-5D score, length of stay, and rehabilitation outcome (measured by mobility score).Many studies have shown the effectiveness of regional blockade in neck of femur fractures, but the techniques used have varied. This study aims to identify whether early and continuous femoral nerve block can be effective in relieving pain and enhancing mobilization.Trial registration.The trial is registered with the European clinical trials database Eudract ref: 2010-023871-25. (17/02/2011).ISRCTN92946117. Registered 26 October 2012.

SUBMITTER: Sahota O

PROVIDER: S-EPMC4051384 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature

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Femoral nerve block Intervention in Neck of Femur fracture (FINOF): study protocol for a randomized controlled trial.

Sahota Opinder O Rowlands Martin M Bradley Jim J Van de Walt Gerrie G Bedforth Nigel N Armstrong Sarah S Moppett Iain I

Trials 20140524

<h4>Background</h4>Hip fractures are very painful leading to lengthy hospital stays. Conventional methods of treating pain are limited. Non-steroidal anti-inflammatories are relatively contraindicated and opioids have significant side effects.Regional anaesthesia holds promise but results from these techniques are inconsistent. Trials to date have been inconclusive with regard to which blocks to use and for how long. Interpatient variability remains a problem.<h4>Methods/design</h4>This is a sin ...[more]

PMID: 24885267

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Project description:BACKGROUND:Traumatic injury of the femur resulting in femoral fracture may result in significant postoperative pain. As with other causes of acute pain, regional anesthesia may offer a benefit over conventional therapy with intravenous opioids. This study prospectively assesses the effects of femoral nerve blockade with a lateral femoral cutaneous nerve block (FN-LFCN) on intraoperative anesthetic requirements, postoperative pain scores, and opioid requirements. MATERIALS AND METHODS:Seventeen pediatric patients (age 2-18 years) undergoing surgical repair of a traumatic femur fracture fulfilled the study criteria and were randomly assigned to general anesthesia with either an FN-LFCN block (n = 10) or intravenous opioids (n = 7). All patients received a general anesthetic with isoflurane for maintenance anesthesia during the surgical repair of the femur fracture. Patients randomized to the FN-LFCN block group received ultrasound-guided nerve blockade using ropivacaine (0.2%/0.5% based on patient weight). At the conclusion of surgery, the airway device was removed once tracheal extubation criteria were achieved, and patients were transported to the post-anesthesia care unit (PACU) for recovery and assessment of pain by a blinded study nurse. RESULTS:The final study cohort included 17 patients (n = 10 for FN-LFCN block group; n = 7 for the intravenous opioid group). Although the median of the maximum postoperative pain scores in the regional group was 0, this did not reach statistical significance when compared to the median pain score of 3 in the intravenous opioid group. Likewise, no difference between the two groups was noted when comparing intraoperative anesthetic requirements, opioid requirements (intraoperative, in the post-anesthesia recovery room, and in the inpatient ward), and the time to first opioid requirement postoperatively in the inpatient ward. CONCLUSION:This prospective, randomized, double-blinded study failed to demonstrate a clear benefit of regional anesthesia over intravenous opioids intraoperatively and postoperatively during repair of femoral shaft fractures in the pediatric population.

Project description:BackgroundThe evidence supporting the benefit of femoral nerve block (FNB) for positioning before spinal anesthesia (SA) in patients suffering from a femur fracture remains inconclusive. In the present study, the authors intended to determine the efficacy and safety of FNB versus an intravenous analgesic (IVA) for positioning before SA in patients with a femur fracture.MethodPubMed, EMBASE, Cochrane, and Scopus databases were searched up to January 2018. We included randomized controlled studies (RCTs) and observational studies that compared FNB versus IVA for the positioning of patients with femur fracture receiving SA. The primary outcome was pain scores during positioning within 30 min before SA. Secondary outcomes were the time for SA, additional analgesic requirements, anesthesiologist's satisfaction with the quality of positioning for SA, participant acceptance, and hemodynamic changes. A random-effects model was used to synthesize the data. We registered the study at PROSPERO with an ID of CRD42018091450.ResultsTen studies with 584 patients were eligible for inclusion. FNB achieved significantly lower pain scores than IVA during positioning within 30 min before SA (pooled standardized mean deviation (SMD): -1.27, 95% confidence interval (CI): -1.84 to -0.70, p < 0.05). A subgroup analysis showed that the analgesic effect was larger in patients in the sitting position for SA than a non-sitting position (sitting position vs non-sitting: pooled SMD: -1.75 (p < 0.05) vs -0.61 (not significant). A multivariate regression showed that the analgesic effect was also associated with age and the total equivalent amount as lidocaine after adjusting for gender (age: coefficient 0.048, p < 0.05; total equivalent amount as lidocaine: coefficient 0.005, p < 0.05). Patients receiving FNB also had a significantly shorter time for SA, greater anesthesiologist satisfaction, and higher patient acceptance than patients receiving IVA. The use of local anesthetics did not produce significant clinical hemodynamic change.ConclusionCompared to IVA, FNB was an effective and safe strategy for the positioning of femur fracture patients for a spinal block, particularly patients who received SA in the sitting position.

Project description:Unsatisfactory analgesia for major knee surgery with femoral nerve block (FNB) alone was reported and the additional benefit of sciatic block to continuous femoral nerve block (CFNB) was not conclusive. The aim of the present study was to find the benefit of the additional mini-dose spinal morphine (0.035 mg) to CFNB for postoperative pain control and to compare their associated side effects after total knee arthroplasty (TKA).After written informed consent and with Institutional Ethics Committee approval, 68 American Society of Anesthesiologists (ASA) Physical Status I-III patients scheduled for elective unilateral TKA under spinal anesthesia (SA) were included in the present prospective, randomized controlled study. The patients were allocated into two groups. CFNB was placed in all patients by the inguinal paravascular approach with 20 ml of 0.25 % levobupivacaine. Group I (named CFNB/SA group), SA was administered with 2.8 ml levobupivacaine and Group II (named CFNB/SAMO group), SA with 2.8 ml levobupivacaine plus morphine 0.035 mg. At Post Anesthesia Care Unit (PACU), pain and other adverse effects were recorded. Pain was assessed by visual analog scale (VAS) 0-10. Tramadol 50 mg intravenous (IV) was given if the VAS > 4. In the ward, all patients were maintained by continuous femoral infusion of 0.125 % levobupivacaine rate 7 ml/hr and then reduced to 5 ml/hr if VAS ≤3.Patient's demographics data in each group were not different. At post-operative (PO) 12-24 h, the VAS scores were significantly lesser in the CFNB/SAMO group. Cumulative tramadol IV requirement for PO48h were also significantly lesser in the CFNB/SAMO group. Nausea, vomiting and numbness were significantly greater in the CFNB/SAMO group during early postoperative period (PO1-6 h).Though in some patients CFNB was inadequate, a mini-dose of intrathecal morphine (0.035 mg) in addition to CFNB was found to be effective with minimal side effects.Thai Clinical Trial Registry (identifier: TCTR20150609003 , date of registration: 6 June 2015).

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Femoral nerve block Intervention in Neck of Femur fracture (FINOF): study protocol for a randomized controlled trial.

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Femoral nerve block Intervention in Neck of Femur fracture (FINOF): study protocol for a randomized controlled trial.

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