About this trial
Wide-awake hand surgery with local anesthetic, no tourniquet and no sedation (WALANT) is increasingly utilized. Conventional anesthesia for hand surgery involves a patient with a block, unable to perform motor function in the arm, and with patient either intubated or sedated, unable to follow surgeon instructions intra-operatively. Flexor tendon repair with a wide awake and cooperative patient is routinely performed successfully at some centres. This method provides several potential benefits including being able to have the patient actively flex the digit and visualize the repair site to assess for any tendon gapping at the repair site, ensure adequate approximation, gliding and absence of triggering. There have not been any prospectively collected randomized controlled trials comparing wide awake vs. regional/general anesthesia in flexor tendon repair. The purpose of our study is to assess for differences in early outcomes including stiffness, patient satisfaction and early complications in wide-awake anesthesia when compared to general/regional anesthesia for flexor tendon repair in zones I and II. Our hypothesis is that there is a lower complication rate and better outcomes when using wide-awake flexor tendon repair.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
over the age of 18
acute single or multiple digit complete flexor tendon lacerations in zones I or II presenting to attending physicians who agree to participate in the study.
Disqualifiers
gross wound contamination
segmental tendon loss
associated finger fractures
sub-acute or chronic ruptures (ruptures > 6 weeks old)
Trial design
Parallel
Treatments tested in this trial
WALANT
Procedure/SurgeryThese patients will receive local anesthetic for flexor tendon repair injected directly into the operative site on the hand. The local anesthetic used 1% lidocaine with 1:100,000 epinephrine.
General/regional anesthesia
Procedure/SurgeryThese patients will receive general/regional anesthesia for flexor tendon repair. This is ropivacaine 0.5% injected by an anesthetist under image-guidance in the axillary region of the arm. If the regional anesthesia is not functioning at the time of OR, this is converted to a general anesthetic as per standard protocol.
WALANT Injection
Drug1% lidocaine with 1:100,000 epinephrine injected directly into operative site. The typical quantity is 5-10cc aliquots.
Regional Anesthetic Injection
Drug0.5% ropivacaine injected under ultrasound guidance into the axilla. The typical quantity is 30-40cc aliquots.
Treatment groups
Trial outcomes
Primary outcomes
Complication rate
Infection requiring antibiotics, tendon rupture, stiffness or contracture requiring tenolysis
Secondary outcomes
Total active range of motion
This is measured as active digit motion measured at the proximal interphalangeal and distal interphalangeal joints with use of a goniometer by a hand therapist
Strickland Criteria Score
The sum of active ranges of motion of the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints. Then the percentage is calculated, in comparison to the contralateral side. The scores are then recorded as one of four categories: Excellent: 85-100%, Good: 70-84%, Fair: 50-69, Poor: 0-49%
Pain of procedure by visual analogue scale (VAS)
Measured on visual analogue scale on a 10cm line and scored out of 10 (0 being no pain and 10 being maximum pain)
Pain of procedure by pain diary
The pain diary is used by the patient at home to record subjective daily pain from 0-10 at a predetermined time every day.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: