Wide-Awake Local Anesthesia For Flexor Tendon Repair

NCT ID: NCT03752957

Last Updated: 2018-11-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2019-10-31

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.

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.

Conditions

Flexor Tendon Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Slah Eldin Koriem

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tarek Abdula ELgamal

Role: STUDY_CHAIR

Assiut University

Amr Elsaid Ali

Role: STUDY_CHAIR

Assiut University

Mohamed Mostafa Kotb

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Mohamed Salah Eldin Koriem

Role: CONTACT

Mohamed.elshreef.mes@gmail.com

+201002766810

Other Identifiers

WideAwake Flexor Tendon Repair

Identifier Type: -

Identifier Source: org_study_id