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AnAnkle Trial study protocol: a randomised trial comparing pain profiles after peripheral nerve block or spinal anaesthesia for ankle fracture surgery.

ABSTRACT: INTRODUCTION:Ankle fracture surgery is a common procedure, but the influence of anaesthesia choice on postoperative pain and quality of recovery is poorly understood. Some authors suggest a benefit of peripheral nerve block (PNB) in elective procedures, but the different pain profile following acute fracture surgery and the rebound pain on cessation of the PNB both remain unexplored. We present an ongoing randomised study aiming to compare primary PNB anaesthesia with spinal anaesthesia for ankle fracture surgery regarding postoperative pain profiles and quality of recovery. METHODS AND ANALYSIS:AnAnkle Trial is a randomised, dual-centre, open-label, blinded analysis trial of 150 adult patients undergoing primary internal fixation of an ankle fracture. Main exclusion criteria are habitual opioid use, impaired pain sensation, other painful injuries or cognitive impairment. The intervention is ultrasound-guided popliteal sciatic (20?mL) and saphenal nerve (8?mL) PNB with ropivacaine 7.5?mg/mL, and controls receive spinal anaesthesia (2?mL) with hyperbaric bupivacaine 5?mg/mL. Postoperatively all receive paracetamol, ibuprofen and patient-controlled intravenous morphine on demand. Morphine consumption and pain scores are registered in the first 27?hours and reported as an integrated pain score as the primary endpoint. Pain score intervals are 3?hours and we will use the area under curve to get a longitudinal measure of pain. Secondary outcomes include rebound pain on cessation of anaesthesia, opioid side effects (Opioid-Related Symptom Distress Scale), quality of recovery (Danish Quality of Recovery-15 score) and pain scores and medication days 1-7 (diary). ETHICS AND DISSEMINATION:The study has been approved by the Regional Ethics Committees in the Capital Region of Denmark, the Danish Data Protection Agency and the Danish Health and Medical Authority. We will publish the results in international peer-reviewed medical journals. TRIAL REGISTRATION NUMBER:AnAnkle Trial is registered in the European Clinical Trials Database (EudraCT 2015-001108-76).

SUBMITTER: Sort R

PROVIDER: S-EPMC5623423 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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AnAnkle Trial study protocol: a randomised trial comparing pain profiles after peripheral nerve block or spinal anaesthesia for ankle fracture surgery.

Sort Rune R Brorson Stig S Gögenur Ismail I Møller Ann Merete AM

BMJ open 20170602 5

<h4>Introduction</h4>Ankle fracture surgery is a common procedure, but the influence of anaesthesia choice on postoperative pain and quality of recovery is poorly understood. Some authors suggest a benefit of peripheral nerve block (PNB) in elective procedures, but the different pain profile following acute fracture surgery and the rebound pain on cessation of the PNB both remain unexplored. We present an ongoing randomised study aiming to compare primary PNB anaesthesia with spinal anaesthesia ...[more]

PMID: 28576901

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Project description:BackgroundA superior analgesic method in perioperative pain-management of patients receiving total knee arthroplasty is the subject of controversial debate. Although higher cost-efficiency is claimed for the local infiltration analgesia (LIA), there is a lack of data on its costs compared to peripheral nerve block anaesthesia (PNBA). The goal of this study was to investigate the differences in immediate perioperative costs between the LIA and PNBA in treatment of patients receiving total knee arthroplasty.MethodsThe comparison was conducted based on a randomized controlled clinical trial examining 40 patients with elective, primary total knee arthroplasty (TKA, 20 patients with LIA and 20 patients with PNBA). The analysis included surgical case costs, anaesthesiological case costs, material, costs of postoperative opioid requirements and catheter review visits for patients receiving PNBA.ResultsThe overall mean costs for the LIA-group were 4328.72€ and 4368.12€ for the PNBA (p = 0.851). While there was no statistically significant difference in surgical case costs, the anaesthesiological costs were lower with the LIA procedure (1370.26€ vs. 1542.45€, p = 0.048). Material costs in the LIA group were 4.18€/patient and 94.64€/patient with the PNBA. Costs for postoperative opioid requirements showed no statistically significant difference between the two procedures.ConclusionsThere is no relevant difference in immediate perioperative costs between LIA and PNBA. Shorter induction times lead to lower anaesthesiological case costs with the LIA. Overall economic aspects seem to play a less important role for determining an adequate procedure for perioperative pain management.Trial registrationThe study was approved by the ethics-review-board of Charité Hospital Berlin (Ethikausschuss 4, Charité - Universitätsmedizin Berlin, on 16th February 2017) and registered with data safety authorities. Study patients provided written informed consent to participate in the trial. Study registry: ClinicalTrials.gov, NCT03114306 .

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: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.

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AnAnkle Trial study protocol: a randomised trial comparing pain profiles after peripheral nerve block or spinal anaesthesia for ankle fracture surgery.

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AnAnkle Trial study protocol: a randomised trial comparing pain profiles after peripheral nerve block or spinal anaesthesia for ankle fracture surgery.

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