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

NCT03135340 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2017-07-17

No results posted yet for this study

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.

Conditions

  • Tendon Injury - Hand

Interventions

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.

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

WALANT Injection

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

DRUG

Regional Anesthetic Injection

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

Sponsors & Collaborators

  • University of Western Ontario, Canada

    lead OTHER

Principal Investigators

  • Ruby Grewal, MD MSc FRCSC · Western University, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2018-11-30
Completion
2033-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03135340 on ClinicalTrials.gov