Wide-Awake Local Anesthesia For Flexor Tendon Repair

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03752957
Collaborator
(none)
40
11

Study Details

Study Description

Brief Summary

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, bow stringing and quadriplegia. Tendon surgery is unique because it should ensure tendon gliding after surgery Tendon surgery now can be performed under local anesthesia without tourniquet, by injecting epinephrine mixed with lidocaine, to achieve vasoconstriction in the area of surgery. This method allows the tendon to move actively during surgery to test tendon function intraoperatively and to ensure the tendon is properly repaired before leaving the operating table.

Wide awake hand surgery is well described by its other name, WALANT which stands for wide awake local anaesthesia no tourniquet. The only two medications most patients are given for wide awake hand surgery are Lidocaine for anaesthesia and epinephrine for haemostasis. In the period before 1950, the belief developed among surgeons that epinephrine causes finger necrosis .The source of the epinephrine myth stemmed from the use of procaine (Novocaine). It was the only safely injectable local anaesthetic until the introduction of Lidocaine in 1948. More fingers died from procaine injection alone than from procaine plus epinephrine injection .no lost finger no case require phentolamine in many studies.

Condition or Disease Intervention/Treatment Phase

    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. Tendon surgery is unique because it should ensure tendon gliding after surgery It has been a standard practice to obtain local or general anesthesia and apply a tourniquet to perform tendon surgery. However, this practice has been changed in recent years...

    Tendon surgery now can be performed under local anesthesia without tourniquet, by injecting epinephrine mixed with lidocaine, to achieve vasoconstriction in the area of surgery. This method allows the tendon to move actively during surgery to test tendon function intraoperatively and to ensure the tendon is properly repaired before leaving the operating table.

    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 Wide awake hand surgery is well described by its other name, WALANT which stands for wide awake local anaesthesia no tourniquet. The only two medications most patients are given for wide awake hand surgery are Lidocaine for anaesthesia and epinephrine for haemostasis. In the period before 1950, the belief developed among surgeons that epinephrine causes finger necrosis .The source of the epinephrine myth stemmed from the use of procaine (Novocaine).8 It was the only safely injectable local anaesthetic until the introduction of Lidocaine in 1948. More fingers died from procaine injection alone than from procaine plus epinephrine injection .no lost finger no case require phentolamine in many studies.The "smoking gun" paper that established that procaine was the actual cause of finger deaths published in the Journal of the American Medical Association that found batches of procaine with a pH of 1 destined for injection into humans.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Wide-Awake Local Anesthesia No Tourniquet Versus. Local/General Anesthesia for Flexor Tendon Repair
    Anticipated Study Start Date :
    Nov 1, 2018
    Anticipated Primary Completion Date :
    May 1, 2019
    Anticipated Study Completion Date :
    Oct 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. post operative complication rate [average 2 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • over the age of 18 acute single or multiple digit complete flexor tendon lacerations in zones I or II
    Exclusion Criteria:
    • gross wound contamination

    • segmental tendon loss

    • associated finger fractures

    • complex or multisystem injuries

    • complex or multisystem injuries

    • mangled hand injuries

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Chair: Tarek Abdula ELgamal, Assiut University
    • Study Chair: Amr Elsaid Ali, Assiut University
    • Study Director: Mohamed Mostafa Kotb, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohamed Slah Eldin Koriem, Assistant Lecturer, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03752957
    Other Study ID Numbers:
    • WideAwake Flexor Tendon Repair
    First Posted:
    Nov 26, 2018
    Last Update Posted:
    Nov 26, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mohamed Slah Eldin Koriem, Assistant Lecturer, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 26, 2018