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

NCT04992351 | Completed

• 1 other identifier: 11335
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Limb Wound; Lower Limb Wound; Anesthesia, Local

Keywords

WALANT; plastic surgery; upper limb; lower limb

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• complications

  at 8 weeks

Study Arms (2)

WALANT group

WALANT was used exclusively as anesthesia method for the operation

Procedure: WALANT

control

tourniquet with regional or general anesthesia was used for the operation

Procedure: WALANT

Interventions

WALANT PROCEDURE

WALANT as anesthesia method for upper and lower limb palstic surgery operations

WALANT group; control

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• upper or lower limb operation
• indication for flap or skin grafting
• operated by the principal investigator

You may not qualify if:

• other concomitant operations performed
• known allergy to any of the ingredients of local anesthesia mixture

Sponsors & Collaborators

• University Hospital, Ioannina: lead

Study Sites (1)

Plastic Surgery Department

Ioannina, Greece

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Professor of Plastic Surgery

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 5, 2021
• Study Start: June 1, 2019
• Primary Completion: October 10, 2022
• Study Completion: May 5, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)