WAFER trial
Research type
Research Study
Full title
A feasibility multicentre randomised controlled trial comparing Wide-awake Local Anaesthesia No Tourniquet (WALANT) versus General and Regional Anaesthesia (GA/RA) for Flexor Tendon Repair (WAFER Trial)
IRAS ID
315954
Contact name
Afshin Mosahebi
Contact email
Sponsor organisation
Royal Free London NHS Foundation Trust Hospital
ISRCTN Number
ISRCTN15052559
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Aim:To perform a feasibility study to establish whether it is possible to conduct a study to compare operations of flexor tendon injuries while patients are awake and without tourniquet (WALANT) compared to current ‘standard of care’.
Background:In the hand, flexor tendons help with bending the fingers and thumb and help with making a fist. Injury to finger tendons is very common following a cut to the hand and can cause loss of finger function. Hence, a cut finger tendon requires surgical repair to stitch the divided tendon ends to regain normal function. This procedure is usually performed when a patient is fully unconscious(general anaesthesia) or by blocking the nerve supply to the entire arm to make it numb(regional anaesthesia). During this procedure, a tourniquet is used to control bleeding to provide the surgeon a clear vision of the cut ends of the tendon. A recent advancement enables this procedure to be performed by only giving an injection to numb the hand(local anaesthesia) which is mixed with adrenaline to control bleeding. This enables the surgery to be performed while patient is fully awake without using a tourniquet. In addition to decreasing the pain related to tourniquet use, importantly, the surgeon can check the quality of the repair by asking the patient to move the finger and make any adjustments to the repair during the surgery.
Design/methods:We will include 60participants with flexor tendon injury:half will receive the new approach and the remaining will receive SoC. The choice of treatment will be decided by chance to ensure that similar type of patients receive the new approach and the SoC. This study will look at whether this type of study is acceptable to patients and clinicians and will help design a larger trial to find out if the new approach is better for patients and NHS.REC name
London - City & East Research Ethics Committee
REC reference
22/PR/1197
Date of REC Opinion
17 Nov 2022
REC opinion
Further Information Favourable Opinion