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

NCT03135340 | Not Yet Recruiting

• 1 other identifier: UWO7788705772
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Complication rate

  Infection requiring antibiotics, tendon rupture, stiffness or contracture requiring tenolysis

  1 year

Secondary Outcomes (7)

• Total active range of motion

  1 year

• Strickland Criteria Score

  1 year

• Pain of procedure by visual analogue scale (VAS)

  1 week

• Pain of procedure by pain diary

  1 week

• Subjective anxiety

  1 week

Study Arms (2)

WALANT

EXPERIMENTAL

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: WALANT; Drug: WALANT Injection

General/regional anesthesia

ACTIVE COMPARATOR

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.

Procedure: General/regional anesthesia; Drug: Regional Anesthetic Injection

Interventions

WALANT PROCEDURE

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.

WALANT

General/regional anesthesia PROCEDURE

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.

General/regional anesthesia

WALANT Injection DRUG

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

WALANT

Regional Anesthetic Injection DRUG

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

General/regional anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Western Ontario, Canada: lead

Related Publications (13)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Lalonde DH. An evidence-based approach to flexor tendon laceration repair. Plast Reconstr Surg. 2011 Feb;127(2):885-890. doi: 10.1097/PRS.0b013e31820467b6.

  PMID: 21285792 BACKGROUND

• 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.

  PMID: 20494744 BACKGROUND

• 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. doi: 10.1016/j.jhsb.2006.06.006. Epub 2006 Aug 22.

  PMID: 16930791 BACKGROUND

• 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.

  PMID: 20885206 BACKGROUND

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

  PMID: 4093459 BACKGROUND

MeSH Terms

Interventions

Anesthesia, Conduction

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Ruby Grewal, MD MSc FRCSC

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruby Grewal, MD MSc FRCSC

CONTACT

519-646-6286; rgrew@uwo.ca

Tym Frank, MD, FRCSC

CONTACT

778-870-5772; tym.frank@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to the treatment received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups. One interventional group and one control group with random allocation as described below.

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: May 1, 2017
• Study Start: August 1, 2017
• Primary Completion: November 1, 2018
• Study Completion (Estimated): November 1, 2033
• Last Updated: July 17, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share