ISRCTN15052559
Active, not recruiting
未知
A feasibility multicentre randomised controlled trial comparing Wide-awake Local Anaesthesia No Tourniquet (WALANT) versus General and Regional Anaesthesia (GA/RA) for Flexor Tendon Repair (WAFER Trial)
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Royal Free London NHS Foundation Trust
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37640464/ (added 29/08/2023)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adults \>\=18 years old
- •2\. Clinical diagnosis of acute flexor tendon injury (100% transected) involving Flexor digitorum profundus and/or Flexor digitorum superficialis, and/or Flexor pollicis longus of the hand
- •3\. Single digit or two digits injury
- •4\. Patient understands and is willing to participate and can comply with follow up regime
Exclusion Criteria
- •1\. Tendon not amendable to primary repair (gross wound contamination, segmental tendon loss, associated fractures or mangled hand injuries)
- •2\. Secondary tendon repair or reconstruction
- •3\. History of allergy to Local anaesthetic (LA)
- •4\. Refusal to have LA or deemed non\-cooperative to be performed without sedation
- •5\. Pre\-existing deformity of finger or hand
- •6\. High risk for GA or not fit for surgery (American society of anaesthesiologist grade \>4\)
Outcomes
Primary Outcomes
Not specified
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