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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Primary repair for flexor tendon lacerations remain the standard of care. However, despite recent advances in knowledge of tendon healing, suture material, and post-operative protocols, outcomes have been reported as fair or poor in 7-20% of patients. Complications encountered include adhesion formation, development of joint contractures, tendon rupture, triggering, bowstringing and quadrigia. Wide-awake flexor tendon repair using local anesthesia and epinephrine with no tourniquet has been described. Safety of epinephrine in digits makes it possible, and epinephrine-induced vasoconstriction precludes the need for a tourniquet and cautery.This approach allows a wide-awake, comfortable, non-sedated, cooperative, tourniquet-free patient to test the freshly repaired tendon with full active range of motion intraoperatively. The surgeon can inspect for bunching, gapping, and triggering of the repair site in an active fashion. Thus, an opportunity is available to revise the repair, trim or add extra sutures, revise pulley reconstruction, or de-bulk tendons before wound closure. This could mean that a higher quality repair is possible and could guide post-operative rehabilitation. It follows that if the patient is unable to achieve total active range of motion intraoperatively they will not be able to postoperatively and may end up requiring a tenolysis. Lalonde and colleagues looked retrospectively at their 15 years of experience using WALANT with the hypothesis that this technique decreased their post-operative rupture rate. With 122 patients there were only 3 ruptures, all due to unexpected forceful movements. Contraindications of this technique include patients who are unable or unwilling to tolerate an operation while awake, pediatric patients, those who are mentally impaired, and complex trauma. Improved compliance with postoperative therapy is also reported after patients visualize the repair in real time and gain a better understanding of limitations and expectations. Patient buy-in to the rehabilitation process is potentially improved if the surgeon can use the operative time to educate the patient, show them the repair, and manage expectations since the patient is wide-awake and coherent. Wide-awake flexor tendon repair could also improve surgeon confidence in initiating a true active motion therapy protocol when the surgeon visualizes the absence of gapping with full finger flexion. Initiation of early active motion could subsequently improve ultimate post-operative range of motion and patient satisfaction. The advent of wide-awake flexor tendon repair could have economic implications as well given that fewer resources are theoretically used for the procedure. Currently there are no prospective randomized controlled studies evaluating outcomes in flexor tendon repairs that have utilized a wide-awake anaesthesia protocol and comparing outcomes with traditional repair techniques. The purpose of this study is to evaluate and compare outcomes of WALANT (wide-awake, local anesthetic, no tourniquet) when compared to traditional general/regional anesthetic for flexor tendon repairs in zone I and II.

Official Title
-----------------
Comparison of Wide-Awake Local Anesthesia vs. Regional/General Anesthesia for Hand Flexor Tendon Repair in Zones I and II: a Prospective Randomized Controlled Trial

Conditions
-----------------
Tendon Injury - Hand

Intervention / Treatment
-----------------
* Procedure: WALANT
* Procedure: General/regional anesthesia
* Drug: WALANT Injection
* Drug: Regional Anesthetic Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: gross wound contamination segmental tendon loss associated finger fractures sub-acute or chronic ruptures (ruptures > 6 weeks old) active or previous infection in the wound bed requirement of delayed repair complex or multisystem injuries multiple digit injuries significant joint injuries amputations (replants) mangled hand injuries.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups. One interventional group and one control group with random allocation as described below.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WALANT<br>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. | Procedure: WALANT<br>* 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.<br>Drug: WALANT Injection<br>* 1% lidocaine with 1:100,000 epinephrine injected directly into operative site. The typical quantity is 5-10cc aliquots.<br>|
| Active Comparator: General/regional anesthesia<br>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. | Procedure: General/regional anesthesia<br>* 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.<br>Drug: Regional Anesthetic Injection<br>* 0.5% ropivacaine injected under ultrasound guidance into the axilla. The typical quantity is 30-40cc aliquots.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Infection requiring antibiotics, tendon rupture, stiffness or contracture requiring tenolysis | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 
| 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% | 1 year | 
| 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) | 1 week | 
| 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. | 1 week | 
| Subjective anxiety | anxiety surrounding procedure as measured on a VAS (from 0 being no anxiety to 10 being maximum anxiety) | 1 week | 
| Repeat procedure question | The patient is asked whether or not they would undergo the procedure the same way again (yes or no). | 1 week | 
| DASH (disabilities of the arm, shoulder and hand) Score | This outcome instrument is a thirty-question self-reported survey of function and symptoms in patients with upper extremity disorders. Scores range from 0 (no disability) to 100 (completely disabled). | 1 year |