Wide-Awake Local Anesthesia vs. Regional/General Anesthesia for Flexor Tendon Repair

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Western Ontario, Canada

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • WALANT

    Procedure/Surgery

    These 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/Surgery

    These 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

    Drug

    1% lidocaine with 1:100,000 epinephrine injected directly into operative site. The typical quantity is 5-10cc aliquots.

  • Regional Anesthetic Injection

    Drug

    0.5% ropivacaine injected under ultrasound guidance into the axilla. The typical quantity is 30-40cc aliquots.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: WALANTExperimental treatment 2 interventions
Group B: General/regional anesthesiaActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Complication rate

Infection requiring antibiotics, tendon rupture, stiffness or contracture requiring tenolysis

Time frame
1 year

Secondary outcomes

1

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

Time frame
1 year
2

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%

Time frame
1 year
3

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)

Time frame
1 week
4

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.

Time frame
1 week

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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