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Clinical Trials/NCT04992351
NCT04992351
Completed
Not Applicable

Wide-awake Local Anesthesia and no Tourniquet (WALANT) in Plastic Surgery: Indications, Clinical Applications and Outcomes

University Hospital, Ioannina1 site in 1 country90 target enrollmentJune 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Upper Limb Wound
Sponsor
University Hospital, Ioannina
Enrollment
90
Locations
1
Primary Endpoint
feasibility of the WALANT method
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
May 5, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Ioannina
Responsible Party
Principal Investigator
Principal Investigator

Konstantinos Seretis

Ass. Professor of Plastic Surgery

University Hospital, Ioannina

Eligibility Criteria

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)

Study Sites (1)

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