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
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,...
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BMJ Publishing Group
2023-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/8/e075440.full |
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| author | Norman R Williams Jason Wong Monica Panca Cecilia Vindrola-Padros Hakim-Moulay Dehbi Afshin Mosahebi Anjana Prasad Waseem Bhat Dariush Nikkhah Muholan Kanapathy Ryan Faderani Juliette Bray Nicola Burr Yazan Al-Ajam |
| author_facet | Norman R Williams Jason Wong Monica Panca Cecilia Vindrola-Padros Hakim-Moulay Dehbi Afshin Mosahebi Anjana Prasad Waseem Bhat Dariush Nikkhah Muholan Kanapathy Ryan Faderani Juliette Bray Nicola Burr Yazan Al-Ajam |
| author_sort | Norman R Williams |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-b5e03c5ed9d64f818fb49d72801ff277 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-b5e03c5ed9d64f818fb49d72801ff2772024-11-15T09:35:10ZengBMJ Publishing GroupBMJ Open2044-60552023-08-0113810.1136/bmjopen-2023-075440WAFER 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 repairNorman R Williams0Jason Wong1Monica Panca2Cecilia Vindrola-Padros3Hakim-Moulay Dehbi4Afshin Mosahebi5Anjana Prasad6Waseem Bhat7Dariush Nikkhah8Muholan Kanapathy9Ryan Faderani10Juliette Bray11Nicola Burr12Yazan Al-Ajam13Division of Surgery and Interventional Science, University College London, London, UKBlond McIndoe Laboratories, Division of Cell Matrix Biology and Regenerative Medicine, Faculty of Biology Medicine and Health, The University of Manchester, Manchester, UKComprehensive Clinical Trials Unit, University College London, London, UKDepartment of Targeted Intervention, University College London, London, UKComprehensive Clinical Trials Unit, University College London, London, UKDivision of Surgery and Interventional Science, University College London, London, UKDepartment of Anaesthesia, Royal Free NHS Foundation Trust Hospital, London, UKDepartment of Plastic and Reconstructive Surgery, Leeds Teaching Hospitals NHS Trust, Leeds, UKDivision of Surgery and Interventional Science, University College London, London, UKDivision of Surgery and Interventional Science, University College London, London, UKDepartment of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, UKDepartment of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, UKDepartment of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, UKDepartment of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, UKIntroduction 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.https://bmjopen.bmj.com/content/13/8/e075440.full |
| spellingShingle | Norman R Williams Jason Wong Monica Panca Cecilia Vindrola-Padros Hakim-Moulay Dehbi Afshin Mosahebi Anjana Prasad Waseem Bhat Dariush Nikkhah Muholan Kanapathy Ryan Faderani Juliette Bray Nicola Burr Yazan Al-Ajam 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/13/8/e075440.full |
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