Tendon Injury - Hand Clinical Trial
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
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04178655 -
Tranexamic Acid Effect on Digit Function Following Primary Repair of Traumatic Digit Flexor Tendon Injuries
|
Early Phase 1 | |
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 |