Use of the WALANT Anesthesia Technique for Forefoot Surgery.

Completed

• Conditions: Orthopedic Disorder
• Interventions: Procedure: Anesthesia

• Registration Number: NCT04858048
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

To compare the perioperative pain level with WALANT anesthesia versus general anesthesia during forefoot surgery.

Detailed Description

Orthopaedic foot and ankle surgery is typically performed while the patient is under general or regional anesthesia. The Wide Awake Local Anesthesia No Tourniquet (WALANT) technique is a local anesthesia technique used since 1980s in Canada for hand surgery. WALANT uses a combination of a local anesthetic and vasoconstrictor to induce anesthesia and hemostasis in the area of the surgical procedure in order to allow surgeries to be done without the use of tourniquet. This practice eliminates the need for the tourniquet due to the hemostatic effect of the vasoconstrictor. The administration of the local anesthetic is done as close as possible to the surgical site, which allows the mobility of the joint to be maintained, while having complete anesthesia. The retention of mobility and the absence of a tourniquet improve patient comfort.

The main objective of this prospective study is to evaluate the perioperative pain level with WALANT anesthesia compared to general anesthesia during forefoot surgery.

Study Timeline

• Study Start: 2021-01-15
• Study First Submitted: 2021-04-15
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-26
• Primary Completion: 2023-04-18
• Study Completion: 2023-04-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Patient, male or female, over 18 years of age
• Patient with scheduled forefoot surgery

Exclusion Criteria

• Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
• Pregnant or breastfeeding woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group with general anesthesia performed during the forefoot surgery	Anesthesia	-
Group with WALANT anesthesia performed during the forefoot surgery	Anesthesia	-

Primary Outcome Measures

Name	Time	Method
Pain assessment	Perioperative	Measure of the pain using the VAS pain scale.

Trial Locations

Locations (1)

Hôpital Privé saint Martin; 🇫🇷 Caen, France