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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 Open Access Protocol BMJ Open: first published as 10.1136/bmjopen-2017-016001 on 2 June 2017. Downloaded from AnAnkle Trial study protocol: a randomised trial comparing pain profiles after peripheral nerve block or spinal anaesthesia for ankle fracture surgery Rune Sort,1 Stig Brorson,2 Ismail Gögenur,3 Ann Merete Møller1 To cite: Sort R, Brorson S, ABSTRACT Strengths and limitations of this study Gögenur I, et al. AnAnkle Trial Introduction Ankle fracture surgery is a common procedure, study protocol: a randomised but the influence of anaesthesia choice on postoperative trial comparing pain profiles ► This is the first trial to thoroughly investigate the pain and quality of recovery is poorly understood. Some after peripheral nerve block or postoperative pain profile and directly compare spinal anaesthesia for ankle authors suggest a benefit of peripheral nerve block the most commonly used regional anaesthesia fracture surgery. BMJ Open (PNB) in elective procedures, but the different pain profile techniques for ankle fracture surgery. following acute fracture surgery and the rebound pain on 2017;7:e016001. doi:10.1136/ ► The trial is randomised and designed with attention bmjopen-2017-016001 cessation of the PNB both remain unexplored. We present to allocation concealment and stratification to an ongoing randomised study aiming to compare primary prevent selection bias. Received 17 January 2017 PNB anaesthesia with spinal anaesthesia for ankle fracture ► The primary endpoint is a composite measure of Revised 31 March 2017 surgery regarding postoperative pain profiles and quality of Accepted 12 April 2017 pain and morphine consumption, which holds more recovery. statistical power than when analysing either of the Methods and analysis AnAnkle Trial is a randomised, dual- two components alone. centre, open-label, blinded analysis trial of 150 adult patients ► Blinding of participants and investigators is not undergoing primary internal fixation of an ankle fracture. feasible; thus, the trial is open-labelled with blinded Main exclusion criteria are habitual opioid use, impaired pain data analysis. sensation, other painful injuries or cognitive impairment. The http://bmjopen.bmj.com/ 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 orthopaedic limb surgery, but its suitability hyperbaric bupivacaine 5 mg/mL. Postoperatively all receive for acute fracture surgery is not well estab- paracetamol, ibuprofen and patient-controlled intravenous lished. morphine on demand. Morphine consumption and pain Ankle fracture is a common acute condi- scores are registered in the first 27 hours and reported as tion, which often requires surgery.1 2 There is an integrated pain score as the primary endpoint. Pain score intervals are 3 hours and we will use the area under curve no evidence-based consensus regarding the on September 29, 2021 by guest. Protected copyright. to get a longitudinal measure of pain. Secondary outcomes best choice of anaesthesia modality for this include rebound pain on cessation of anaesthesia, opioid high-volume procedure, and the influence of side effects (Opioid-Related Symptom Distress Scale), quality this choice on the postoperative pain profile is of recovery (Danish Quality of Recovery-15 score) and pain poorly understood. Spinal anaesthesia (SA) is scores and medication days 1–7 (diary). most common, but PNBs are becoming widely Ethics and dissemination The study has been approved implemented, as they provide long-lasting pain by the Regional Ethics Committees in the Capital Region of 3–7 1Department of Anaesthesiology, control and are regarded very safe. There Herlev and Gentofte University Denmark, the Danish Data Protection Agency and the Danish is some evidence that PNBs used in elective Hospital, Copenhagen, Denmark Health and Medical Authority. We will publish the results in surgical procedures on knee, ankle and foot 2 international peer-reviewed medical journals. Department of Orthopaedic are effective in reducing pain, opioid consump- Surgery, Herlev and Gentofte Trial registration number AnAnkle Trial is registered tion and related side effects such as nausea University Hospital, Copenhagen, in the European Clinical Trials Database (EudraCT 2015- Denmark 001108-76). and vomiting, as well as potentially reducing 3Department of Surgery, Centre length of hospital stay and increasing patient for Surgical Science, Zealand satisfaction.4 8–16 However, PNBs can represent University Hospital, Copenhagen, INTRODUCTION a logistical challenge in the acute setting and, Denmark Peripheral nerve blocks (PNB) are getting moreover, the pain profile following fractures Correspondence to increasingly popular for both primary anaes- and fracture surgery is naturally different from Dr. Rune Sort; sort@ dadlnet. dk thesia and postoperative pain control in that of conditions requiring elective surgery. Sort R, et al. BMJ Open 2017;7:e016001. doi:10.1136/bmjopen-2017-016001 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2017-016001 on 2 June 2017. Downloaded from Very few studies have investigated the efficacy and Inclusion criteria possible benefits of PNBs in this context and results 1. Scheduled for internal fixation of an ankle fracture. are incongruous. One randomised study of postopera- 2. Age >18 years. tive pain scores in ankle fracture surgery showed initial 3. Ability to read and understand Danish and give benefit with PNB added to general anaesthesia but also informed written consent. revealed a sizeable ‘rebound pain’ on cessation of the PNBs, which could challenge the overall benefit on the 17 Exclusion criteria postoperative pain profile. Another randomised study 1. Allergy towards non-steroidal anti-inflammatory of bimalleolar fracture surgery patients showed a longer drugs, paracetamol, morphine or local anaesthetics. postoperative effect of PNB anaesthesia compared with SA 2. Bodyweight <52 kg to avoid toxic doses of local measured as time to first analgesic request, but pain levels 18 anaesthetics. were not measured. At our centre, a large retrospec- 3. Contraindications for SA. tive study of postoperative opioid consumption in ankle 4. Current gastrointestinal bleeding. fracture surgery has suggested that the largest benefit 5. Proximal fibular fracture or multitrauma/other of the regional anaesthesia modalities is obtained with 19 simultaneous fractures. PNBs. However, in a prospective exploratory pilot study 6. Cognitive or psychiatric dysfunction or alcohol/ investigating primary PNB anaesthesia for ankle fracture narcotic substance abuse causing expected inability surgery, we also found a clear indication of rebound pain to comply with study protocol. in relation to cessation of the PNB effect, especially in 20 7. No available anaesthesiologist with PNB capability younger individuals (abstract published). at scheduled time of operation. We hypothesise the following: 8. Neuropathy/neurological dysfunction in the lower 1. PNB anaesthesia for ankle fracture surgery reduces extremities. overall postoperative pain, opioid use and opioid- 9. Habitual daily use of opioids. related side effects compared with SA. 10. Pregnancy or breast feeding. 2. Rebound pain following cessation of PNB 11. Infection at anaesthesia injection site. anaesthesia is more pronounced than rebound 12. Nephropathy requiring dialysis. pain following cessation of SA after ankle fracture 13. Acute porphyria. surgery. 3. Patient-reported quality of recovery after ankle Recruitment period fracture surgery is better following PNB anaesthesia All legislative and ethical approvals were obtained and the than following SA. trial registered in the European Clinical Trials Database 21 22 (EudraCT 2015-001108-76) by June 2015. Inclusion http://bmjopen.bmj.com/ We therefore aim to assess the postoperative pain was initiated in July 2015 and will continue until 150 profile and quality of recovery after acute ankle fracture patients have been included and their primary outcome surgery in a randomised setting comparing primary PNB data secured in an expected inclusion period of 22–24 anaesthesia with SA. months. Sample size estimation METHODS AND ANALYSIS The target sample size for AnAnkle Trial is 150 partici- Trial design pants. This estimation for the primary outcome (IPS) on September 29, 2021 by guest. Protected copyright. AnAnkle Trial is a prospective, randomised, parallel is based on the O’Brien Castello formula by calculating group, dual-centre, open-label, blinded analysis trial Wilcoxon-Mann-Whitney odds (WMW odds) for sample designed to assess the postoperative pain profile and sizing in non-parametric statistics.23 24 Prior studies have quality of recovery following ankle fracture surgery shown a positive correlation between the two parame- under PNB anaesthesia compared with SA. The study ters on which the IPS is based, that is, higher pain scores is conducted in two university hospitals in the Capital are associated with a higher opioid consumption and Region of Denmark. Trial participants are randomly vice versa.23 Using data from our observational study, assigned to either SA or PNB anaesthesia as described we designed the trial to be able to detect a simultaneous below. Primary data are patient-reported pain scores and 30% difference in both morphine consumption and pain on demand morphine consumption reported as an inte- scores as we consider this a clinically meaningful differ- grated pain score
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