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临床试验/NCT03752957
NCT03752957Unknown不适用

Wide-Awake Local Anesthesia No Tourniquet Versus. Local/General Anesthesia for Flexor Tendon Repair

Assiut University0 个研究点目标入组 40 人开始时间: 2018年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
post operative complication rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

post operative complication rate

时间窗: average 2 months

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Slah Eldin Koriem

Assistant Lecturer

Assiut University

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