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

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Lower Limb Wound; Upper Limb Wound
• Intervention / Treatment: Procedure: WALANT

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 Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Greece
  • Ioannina, Greece
    • Plastic Surgery Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients who undergo general plastic surgery operations in the upper or lower limb

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
WALANT group; WALANT was used exclusively as anesthesia method for the operation	Procedure: WALANT; WALANT as anesthesia method for upper and lower limb palstic surgery operations
control; tourniquet with regional or general anesthesia was used for the operation	Procedure: WALANT; WALANT as anesthesia method for upper and lower limb palstic surgery operations

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications	number and type of complications in each group	at 8 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Ioannina

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): May 5, 2023

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: lower limb; upper limb; plastic surgery; WALANT
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 11335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No