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

July 12, 2017 updated by: University of Western Ontario, Canada

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ruby Grewal, MD MSc FRCSC
  • Phone Number: 519-646-6286
  • Email: rgrew@uwo.ca

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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)
Time Frame: 1 week
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
Time Frame: 1 week
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
Time Frame: 1 week
anxiety surrounding procedure as measured on a VAS (from 0 being no anxiety to 10 being maximum anxiety)
1 week
Repeat procedure question
Time Frame: 1 week
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
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Western Ontario, Canada

Investigators

  • Principal Investigator: Ruby Grewal, MD MSc FRCSC, Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2017

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2033

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

May 1, 2017

Study Record Updates

Last Update Posted (Actual)

July 17, 2017

Last Update Submitted That Met QC Criteria

July 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UWO7788705772

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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