Wide-awake Local Anesthesia and no Tourniquet (WALANT) in Plastic Surgery

Completed

• Conditions: Upper Limb Wound; Lower Limb Wound; Anesthesia, Local
• Interventions: Procedure: WALANT

• Registration Number: NCT04992351
• Lead Sponsor: University Hospital, Ioannina

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 Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-08-05
• Primary Completion: 2022-10-10
• Study Completion: 2023-05-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
WALANT group	WALANT	WALANT was used exclusively as anesthesia method for the operation
control	WALANT	tourniquet with regional or general anesthesia was used for the operation

Primary Outcome Measures

Name	Time	Method
feasibility of the WALANT method	through operation completion	percentage of cases, which could not be completed under WALANT with conversion to the traditional method of anesthesia
total operation time	through operation completion	the difference between skin incision and skin closure in minutes
operation theatre time	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	at 8 weeks	estimated by a 10-point visual analogue scale (1-10, 10 is the best outcome)

Secondary Outcome Measures

Name	Time	Method
complications	at 8 weeks	number and type of complications in each group

Trial Locations

Locations (1)

Plastic Surgery Department; 🇬🇷 Ioannina, Greece