WAFER trial: a study protocol for a feasibility randomised controlled trial comparing wide-awake local anaesthesia no tourniquet (WALANT) to general and regional anaesthesia with tourniquet for flexor tendon repair

Abstract

Introduction: Flexor tendons are traditionally repaired under either general anaesthesia (GA) or regional anaesthesia (RA), allowing for the use of an arm tourniquet to minimise blood loss and establish a bloodless surgical field. However, the use of tourniquets exposes the patient to certain risks, including skin, muscle and nerve injuries. A recent advancement in anaesthesia delivery involves the use of a wide-awake approach where no sedation nor tourniquets are used (wide-awake local anaesthesia no tourniquet (WALANT)). WALANT uses local anaesthetic with epinephrine to provide pain relief and vasoconstriction, reducing operative bleeding. Several studies revealed potential benefits for WALANT compared with GA or RA. However, there remains a paucity of high-quality evidence to support the use of WALANT. As a result of this uncertainty, the clinical practice varies considerably. We aim to evaluate the feasibility of WALANT as an alternative to GA and RA in patients undergoing surgical repair of flexor tendon injuries. This involves addressing factors such as clinician and patient support for a trial, clinical equipoise, trial recruitment and dropout and the most relevant outcomes measures for a future definitive trial.

Methods and analysis: WAFER is a multicentre, single-blinded, parallel group, randomised controlled trial (RCT) to assess the feasibility of WALANT versus RA and GA. The target population is patients with acute traumatic flexor tendon injuries, across 3 major hand surgery units in England involving a total of 60 participants. Outcome assessors will be blinded. The primary outcome will be the ability to recruit patients into the trial, while secondary outcomes include difference in functional outcome, patient-reported outcome measures, health-related quality of life, cost-effectiveness and complication rates.

Ethics and dissemination: Ethical approval was obtained from the London-City and East Research Ethics Committee (22/PR/1197). Findings will be disseminated through peer-reviewed publication, conferences, patient information websites and social media networks.

Trial registration number: ISRCTN identifier: 15052559.

Keywords: ANAESTHETICS; Anaesthesia in orthopaedics; Hand & wrist; PLASTIC & RECONSTRUCTIVE SURGERY; Plastic & reconstructive surgery.

Figure 1

Flow chart on patient’s journey throughout the study. A&E, accident and emergency; BSSH, British Society for Surgery of the Hand; EQ-5D-5L, EuroQol 5 Dimensions 5 Levels instrument; GA, general anaesthesia; LA, local anaesthesia; MHQ, Michigan Hand Outcomes Questionnaire; RA, regional anaesthesia; TAM, Total Active Motion; VAS, Visual Analogue Score; WPAI-SHP, Work Productivity and Activity Impairment Questionnaire: Specific Health Problem.