CompletedInterventional

A study to evaluate operation of flexor tendon injury under local anaesthesia compared to general or regional anaesthesia

Flexor tendons help you curl your fingers and make a fist. If you cut these tendons, you need an operation to stitch them back together. Usually, surgeons carry out this repair while you are asleep under general anaesthesia or with your whole arm numbed by a regional nerve block, using a tight arm band to stop bleeding. A newer technique allows the repair to happen while you stay fully awake. Doctors inject local anaesthetic and medicine into the hand to numb the area and control bleeding without an arm band. This lets you move your fingers during surgery so the surgeon can test the stitch straight away. This trial compares the awake method with traditional anaesthesia in 60 adults to see if running a larger UK study is practical. Taking part helps doctors understand if one approach provides better recovery and value for the NHS.

At a glance

Status

Completed

Sponsor

Royal Free London NHS Foundation Trust

Enrolment target

Start

01 Mar 2023

Estimated completion

31 Jul 2024

Surgery for flexor tendon injuries

What is this study about?

Tendons are strong cords of tissue that connect muscle to bone. In your hand, flexor tendons run along your palm and fingers, allowing you to bend your fingers and grasp objects. When a deep cut snaps one of these tendons, you lose normal movement. Repairing a severed tendon requires surgery so that the cut ends can be stitched back together securely.

Traditionally, this operation happens while you are completely unconscious under a general anaesthetic, or with your entire arm made numb using a regional nerve block. Both methods usually involve a tight band (a tourniquet) around your upper arm to temporarily stop blood flow, giving the surgeon a clear view. While effective, the tight band can feel uncomfortable, and doctors cannot check your finger movement until after you wake up and start healing.

Surgeons have developed a newer approach called WALANT (Wide-Awake Local Anaesthesia No Tourniquet). In this technique, you receive a local injection that numbs only the hand and contains a medicine to control bleeding, so no tight arm band is needed. Because you stay awake, the surgeon can ask you to gently bend your fingers during the procedure. This lets them test how well the stitched tendon glides before finishing the operation.

This study, known as the WAFER trial, is a feasibility study taking place across NHS hospitals. It will involve 60 patients to test whether people are happy to be placed into either group by chance and whether this type of study can run smoothly. The findings will help researchers design a larger trial to confirm which method gives patients the best long-term hand function.

Key takeaways

The WAFER trial compares awake hand surgery against standard anaesthesia for cut finger tendons.
The awake method avoids using a tight arm band and lets the surgeon test your finger movement immediately.
Participants are randomly assigned to either the awake approach or traditional care.
All operations are performed by experienced plastic surgery teams in NHS hospitals.
Participation is voluntary, and you are free to leave the study at any point without affecting your care.

Who may be eligible?

You may be able to take part if you are aged 18 or over and have recently suffered a clean, complete cut to the flexor tendons in one or two fingers or your thumb. You must be able to attend your follow-up appointments and take part in hand therapy exercises afterwards.

You will not be able to join if your injury involves severe crush damage, broken bones in the same area, or heavily contaminated wounds that prevent a standard primary repair. People who need a delayed reconstruction rather than an urgent repair are also not eligible.

Additionally, this study is not suitable for individuals with known allergies to local numbing medicines, those who feel unable to stay calm during an awake procedure without sedation, people with pre-existing hand deformities, or those whose overall health makes surgery unusually risky.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have a newly cut flexor tendon in one or two fingers or my thumb.
I do not have broken bones or severe crush damage in the injured hand.
I have no known allergy to local anaesthetic injections.
I feel comfortable with the idea of being awake during surgery if selected for that group.
I am able to attend hospital follow-up visits and hand therapy sessions.

Answer every question to see your result.

What does participation involve?

If you choose to participate, you will be placed into one of two treatment groups by chance (a computer-generated process called randomisation). Half of the participants will receive the awake local anaesthetic repair without an arm band, while the other half will receive standard care, which involves either general anaesthetic or a regional arm block with a tourniquet.

Both groups have their repair carried out by experienced NHS plastic surgeons. During the awake procedure, you will be resting comfortably while only your hand is numbed. In standard care, you will either sleep through the surgery or have your arm numbed from the shoulder or elbow down. The operation itself follows standard surgical techniques used in NHS hospitals.

After your operation, you will follow the standard recovery path for cut tendons. This includes outpatient visits to check your wound healing and regular hand therapy sessions to regain movement. You will also be asked to share your thoughts on the experience and complete brief questionnaires about how well your hand is healing. The overall study runs from December 2022 to April 2025, and your involvement covers your normal surgical recovery and follow-up period.

Potential risks and benefits

Taking part may not give you any direct personal benefit over having standard surgery, but your involvement will help doctors decide the best way to care for future patients with hand injuries. All surgical procedures carry standard risks, regardless of the study. These include a small risk of infection, wound swelling, stiffness, temporary nerve tingling, or the repaired tendon snapping (which happens in fewer than 1 in 20 cases). In very rare cases (fewer than 1 in 100), people develop long-term hand pain known as complex regional pain syndrome. Both anaesthetic techniques are already routinely used in the NHS. Taking part is entirely voluntary, and you can withdraw at any time without your regular medical care being affected.

Locations (4)

Royal Free Hospital
Approximate
London, England
Manchester University NHS Foundation Trust
City only
Manchester, England
United Leeds Teaching Hospitals NHS Trust
City only
Leeds, England
Barts Health NHS Trust
City only
London, England

Common questions

Will I feel pain if I have the awake surgery?

No. The local anaesthetic completely numbs the area being operated on. You may feel gentle touching or movement, but you should not feel sharp pain. If you feel any discomfort, the surgical team can add more numbing medicine.

Can I choose which anaesthetic I get?

No. A computer randomly assigns you to either the awake local anaesthetic group or standard care. This fair comparison is essential to find out if one technique offers clearer advantages.

What happens if I feel anxious during an awake procedure?

The surgical team is experienced in keeping patients calm and comfortable. They will talk to you throughout. If at any point you feel unable to continue awake, the team will ensure you are supported and safe.

Does the type of anaesthetic change how my cut heals?

Current evidence suggests both methods allow the tendon and skin to heal well. In the awake method, the surgeon can check tendon movement during the operation, but your body still needs several weeks of careful recovery.

Do I have to pay anything to take part?

No. This trial is funded by the National Institute for Health and Care Research (NIHR) and takes place within the NHS. All treatments are provided as part of standard hospital care.

How to find out more

Muholan Kanapathy

m.kanapathy@ucl.ac.uk +44 20 7443 9757 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.