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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03135340
Study type Interventional
Source Western University, Canada
Contact Ruby Grewal, MD MSc FRCSC
Phone 519-646-6286
Email rgrew@uwo.ca
Status Not yet recruiting
Phase N/A
Start date August 2017
Completion date November 2033

See also
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Completed NCT03823755 - Evaluation of the Mobility of the Digital Flexor Tendons
Active, not recruiting NCT03622372 - Zone 2 Flexor Tendon Repair With CoNextions TR Implant System Phase 3
Completed NCT06198582 - The Effect of Virtual Reality Based Task Specific Exercises in Patients With Hand Flexor Tendon Injury N/A
Recruiting NCT04962490 - Study of the Repair of Flexor Tendons of the Hand
Completed NCT04385485 - Passive Mobilization With Place and Hold vs Active Mobilization Therapy After Flexor Tendon Repair N/A
Completed NCT04618107 - Wide Awake Surgery for Tendon Repair in Hand Trauma N/A
Recruiting NCT04312412 - Outcome of the Treatment of Flexor Tendon Injuries
Active, not recruiting NCT06313489 - Rupture of Thumb's Long Extensor Tendon After Fracture of the Distal Radius, Study of Muscle and Tendon Pathology
Not yet recruiting NCT04787835 - The Effect of Forearm Nerve Blocks on Pain-free Tourniquet Time Compared to Local Anesthetic for Awake Hand Surgery N/A
Completed NCT04742296 - The Effects of Low-level Laser Therapy in Extensor Tendon Injuries Between Zones 5-8 N/A