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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03135340
• Other study ID #: UWO7788705772
• Status: Not yet recruiting
• Phase: N/A
• First received: December 6, 2016
• Last updated: July 12, 2017
• Start date: August 2017
• Est. completion date: November 2033

Study information

• Verified date: April 2017
• Source: Western University, Canada
• Contact: Ruby Grewal, MD MSc FRCSC
• Phone: 519-646-6286
• Email: rgrew[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: November 2033
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tendon Injuries
• Tendon Injury - Hand

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Western Ontario, Canada

References & Publications (13)

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. Review. — View Citation

Dowd MB, Figus A, Harris SB, Southgate CM, Foster AJ, Elliot D. The results of immediate re-repair of zone 1 and 2 primary flexor tendon repairs which rupture. J Hand Surg Br. 2006 Oct;31(5):507-13. Epub 2006 Aug 22. — View Citation

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):941-5. doi: 10.1097/PRS.0b013e3181e60489. — View Citation

Lalonde DH. An evidence-based approach to flexor tendon laceration repair. Plast Reconstr Surg. 2011 Feb;127(2):885-90. doi: 10.1097/PRS.0b013e31820467b6. — View Citation

Lalonde DH. Wide-awake flexor tendon repair. Plast Reconstr Surg. 2009 Feb;123(2):623-5. doi: 10.1097/PRS.0b013e318195664c. — View Citation

Lilly SI, Messer TM. Complications after treatment of flexor tendon injuries. J Am Acad Orthop Surg. 2006 Jul;14(7):387-96. Review. — View Citation

Momeni A, Grauel E, Chang J. Complications after flexor tendon injuries. Hand Clin. 2010 May;26(2):179-89. doi: 10.1016/j.hcl.2009.11.004. Review. — View Citation

Mustoe TA, Buck DW 2nd, Lalonde DH. The safe management of anesthesia, sedation, and pain in plastic surgery. Plast Reconstr Surg. 2010 Oct;126(4):165e-176e. doi: 10.1097/PRS.0b013e3181ebe5e9. Review. — View Citation

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. — View Citation

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. — View Citation

Strickland JW. Results of flexor tendon surgery in zone II. Hand Clin. 1985 Feb;1(1):167-79. — View Citation

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. — View Citation

Wilhelmi BJ, Blackwell SJ, Miller J, Mancoll JS, Phillips LG. Epinephrine in digital blocks: revisited. Ann Plast Surg. 1998 Oct;41(4):410-4. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate	Infection requiring antibiotics, tendon rupture, stiffness or contracture requiring tenolysis	1 year
Secondary	Total active range of motion	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
Secondary	Strickland Criteria Score	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
Secondary	Pain of procedure by visual analogue scale (VAS)	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
Secondary	Pain of procedure by pain diary	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
Secondary	Subjective anxiety	anxiety surrounding procedure as measured on a VAS (from 0 being no anxiety to 10 being maximum anxiety)	1 week
Secondary	Repeat procedure question	The patient is asked whether or not they would undergo the procedure the same way again (yes or no).	1 week
Secondary	DASH (disabilities of the arm, shoulder and hand) Score	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