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

Primary Purpose

Tendon Injury - Hand

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
WALANT
General/regional anesthesia
WALANT Injection
Regional Anesthetic Injection
Sponsored by
University of Western Ontario, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendon Injury - Hand

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    WALANT

    General/regional anesthesia

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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
    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%
    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)
    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.
    Subjective anxiety
    anxiety surrounding procedure as measured on a VAS (from 0 being no anxiety to 10 being maximum anxiety)
    Repeat procedure question
    The patient is asked whether or not they would undergo the procedure the same way again (yes or no).
    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).

    Full Information

    First Posted
    December 6, 2016
    Last Updated
    July 12, 2017
    Sponsor
    University of Western Ontario, Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03135340
    Brief Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2017 (Anticipated)
    Primary Completion Date
    November 2018 (Anticipated)
    Study Completion Date
    November 2033 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Western Ontario, Canada

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tendon Injury - Hand

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two groups. One interventional group and one control group with random allocation as described below.
    Masking
    Outcomes Assessor
    Masking Description
    The outcomes assessor will be blinded to the treatment received.
    Allocation
    Randomized
    Enrollment
    88 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    WALANT
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    General/regional anesthesia
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    WALANT
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    General/regional anesthesia
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    WALANT Injection
    Intervention Description
    1% lidocaine with 1:100,000 epinephrine injected directly into operative site. The typical quantity is 5-10cc aliquots.
    Intervention Type
    Drug
    Intervention Name(s)
    Regional Anesthetic Injection
    Intervention Description
    0.5% ropivacaine injected under ultrasound guidance into the axilla. The typical quantity is 30-40cc aliquots.
    Primary Outcome Measure Information:
    Title
    Complication rate
    Description
    Infection requiring antibiotics, tendon rupture, stiffness or contracture requiring tenolysis
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Total active range of motion
    Description
    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
    Time Frame
    1 year
    Title
    Strickland Criteria Score
    Description
    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%
    Time Frame
    1 year
    Title
    Pain of procedure by visual analogue scale (VAS)
    Description
    Measured on visual analogue scale on a 10cm line and scored out of 10 (0 being no pain and 10 being maximum pain)
    Time Frame
    1 week
    Title
    Pain of procedure by pain diary
    Description
    The pain diary is used by the patient at home to record subjective daily pain from 0-10 at a predetermined time every day.
    Time Frame
    1 week
    Title
    Subjective anxiety
    Description
    anxiety surrounding procedure as measured on a VAS (from 0 being no anxiety to 10 being maximum anxiety)
    Time Frame
    1 week
    Title
    Repeat procedure question
    Description
    The patient is asked whether or not they would undergo the procedure the same way again (yes or no).
    Time Frame
    1 week
    Title
    DASH (disabilities of the arm, shoulder and hand) Score
    Description
    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).
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ruby Grewal, MD MSc FRCSC
    Phone
    519-646-6286
    Email
    rgrew@uwo.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tym Frank, MD, FRCSC
    Phone
    778-870-5772
    Email
    tym.frank@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ruby Grewal, MD MSc FRCSC
    Organizational Affiliation
    Western University, Canada
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    4560071
    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. No abstract available.
    Results Reference
    background
    PubMed Identifier
    1998024
    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. doi: 10.1097/00006534-199103000-00023.
    Results Reference
    background
    PubMed Identifier
    16822886
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9788222
    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. doi: 10.1097/00000637-199810000-00010.
    Results Reference
    background
    PubMed Identifier
    11420511
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24009436
    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. doi: 10.1177/229255030301100408.
    Results Reference
    background
    PubMed Identifier
    20463621
    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):941-945. doi: 10.1097/PRS.0b013e3181e60489.
    Results Reference
    background
    PubMed Identifier
    19182622
    Citation
    Lalonde DH. Wide-awake flexor tendon repair. Plast Reconstr Surg. 2009 Feb;123(2):623-625. doi: 10.1097/PRS.0b013e318195664c. No abstract available.
    Results Reference
    background
    PubMed Identifier
    21285792
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20494744
    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.
    Results Reference
    background
    PubMed Identifier
    16930791
    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. doi: 10.1016/j.jhsb.2006.06.006. Epub 2006 Aug 22.
    Results Reference
    background
    PubMed Identifier
    20885206
    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.
    Results Reference
    background
    PubMed Identifier
    4093459
    Citation
    Strickland JW. Results of flexor tendon surgery in zone II. Hand Clin. 1985 Feb;1(1):167-79.
    Results Reference
    background

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