Wide-Awake Local Anesthesia For Flexor Tendon Repair

NCT03752957 | Unknown

• 1 other identifier: WideAwake Flexor Tendon Repair
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Flexor Tendon Injury

Keywords

Wide-Awake Local Anesthesia

Outcome Measures

Primary Outcomes (1)

• post operative complication rate

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

  average 2 months

Eligibility Criteria

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

Study Population

Assiut University Hospital , microsurgery unit

You may qualify if:

• over the age of 18 acute single or multiple digit complete flexor tendon lacerations in zones I or II

You may not qualify if:

• gross wound contamination
• segmental tendon loss
• associated finger fractures
• complex or multisystem injuries
• complex or multisystem injuries
• mangled hand injuries

Sponsors & Collaborators

• Assiut University: lead

Study Officials

• Tarek Abdula ELgamal

  Assiut University

  STUDY CHAIR

• Amr Elsaid Ali

  Assiut University

  STUDY CHAIR

• Mohamed Mostafa Kotb

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Mohamed Salah Eldin Koriem

CONTACT

+201002766810; Mohamed.elshreef.mes@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 26, 2018
• Study Start: November 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: October 1, 2019
• Last Updated: November 26, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share