Wide-awake Local Anesthesia and no Tourniquet (WALANT) in Plastic Surgery: Indications, Clinical Applications and Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- feasibility of the WALANT method
Study Overview
Brief Summary
Wide-awake local anesthesia no tourniquet (WALANT) was proposed and performed in hand operations.
Aim of this study is to present the use of WALANT in operations performed on the upper and lower limbs, evaluate its efficacy in terms of feasibility, total operation time, total operating room time, bleeding, patient discomfort and satisfaction and control for potential drawbacks. The hypothesis is that WALANT is a viable option in common operations performed by plastic surgeons on the upper and lower limbs.
Detailed Description
Wide-awake local anesthesia no tourniquet (WALANT) was proposed and performed in hand operations. Little has been studied, regarding its indications and efficacy in general plastic surgery operations.
Aim of this study is to present the use of WALANT in operations performed on the upper and lower limbs, evaluate its efficacy in terms of feasibility, total operation time, total operating room time, bleeding, patient discomfort and satisfaction and control for potential drawbacks. The hypothesis is that WALANT is a viable option in common operations performed by plastic surgeons on the upper and lower limbs.
A prospective study will be conducted comparing the use of WALANT in operations performed on the upper and lower limbs to the traditional use of tourniquet with general or regional anesthesia.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •upper or lower limb operation
- •indication for flap or skin grafting
- •operated by the principal investigator
Exclusion Criteria
- •other concomitant operations performed
- •known allergy to any of the ingredients of local anesthesia mixture
Outcomes
Primary Outcomes
feasibility of the WALANT method
Time Frame: through operation completion
percentage of cases, which could not be completed under WALANT with conversion to the traditional method of anesthesia
total operation time
Time Frame: through operation completion
the difference between skin incision and skin closure in minutes
operation theatre time
Time Frame: through operation completion with exit from the operation theatre
the difference between entry and exit of the patient from the operation theatre in minutes
Patient satisfaction
Time Frame: at 8 weeks
estimated by a 10-point visual analogue scale (1-10, 10 is the best outcome)
Secondary Outcomes
- complications(at 8 weeks)
Investigators
Konstantinos Seretis
Ass. Professor of Plastic Surgery
University Hospital, Ioannina