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

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

Overview

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.

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.

Primary outcome measures

• Complication rate [Time frame: 1 year]

Secondary outcome measures (7)

• Total active range of motion [Time frame: 1 year]
• Strickland Criteria Score [Time frame: 1 year]
• Pain of procedure by visual analogue scale (VAS) [Time frame: 1 week]
• Pain of procedure by pain diary [Time frame: 1 week]
• Subjective anxiety [Time frame: 1 week]
• Repeat procedure question [Time frame: 1 week]
• DASH (disabilities of the arm, shoulder and hand) Score [Time frame: 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Verdan CE. Half a century of flexor-tendon surgery. Current status and changing philosophies. J Bone Joint Surg Am. 1972 Apr;54(3):472-91. No abstract available. PMID 4560071
• Saldana MJ, Chow JA, Gerbino P 2nd, Westerbeck P, Schacherer TG. Further experience in rehabilitation of zone II flexor tendon repair with dynamic traction splinting. Plast Reconstr Surg. 1991 Mar;87(3):543-6. doi: 10.1097/00006534-199103000-00023. PMID 1998024
• Lilly SI, Messer TM. Complications after treatment of flexor tendon injuries. J Am Acad Orthop Surg. 2006 Jul;14(7):387-96. doi: 10.5435/00124635-200607000-00001. PMID 16822886
• Wilhelmi BJ, Blackwell SJ, Miller J, Mancoll JS, Phillips LG. Epinephrine in digital blocks: revisited. Ann Plast Surg. 1998 Oct;41(4):410-4. doi: 10.1097/00000637-199810000-00010. PMID 9788222
• Denkler K. A comprehensive review of epinephrine in the finger: to do or not to do. Plast Reconstr Surg. 2001 Jul;108(1):114-24. doi: 10.1097/00006534-200107000-00017. PMID 11420511
• Nodwell T, Lalonde D. How long does it take phentolamine to reverse adrenaline-induced vasoconstriction in the finger and hand? A prospective, randomized, blinded study: The Dalhousie project experimental phase. Can J Plast Surg. 2003 Winter;11(4):187-90. doi: 10.1177/229255030301100408. PMID 24009436
• Higgins A, Lalonde DH, Bell M, McKee D, Lalonde JF. Avoiding flexor tendon repair rupture with intraoperative total active movement examination. Plast Reconstr Surg. 2010 Sep;126(3):941-945. doi: 10.1097/PRS.0b013e3181e60489. PMID 20463621
• Lalonde DH. Wide-awake flexor tendon repair. Plast Reconstr Surg. 2009 Feb;123(2):623-625. doi: 10.1097/PRS.0b013e318195664c. No abstract available. PMID 19182622

Identifiers

NCT: NCT03135340 · UWO7788705772

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗