Use of the WALANT Anesthesia Technique for Forefoot Surgery. (WALANT)

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

Study Overview

• Status: Completed
• Conditions: Orthopedic Disorder
• Intervention / Treatment: Procedure: Anesthesia

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 Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• France
  • Caen, France, 14050
    • Hôpital Prive Saint Martin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with scheduled forefoot surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group with general anesthesia performed during the forefoot surgery	Procedure: Anesthesia; 2 types of anesthesia (general and WALANT) performed during the surgery
Group with WALANT anesthesia performed during the forefoot surgery	Procedure: Anesthesia; 2 types of anesthesia (general and WALANT) performed during the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	Measure of the pain using the VAS pain scale.	Perioperative

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Investigators: Principal Investigator: François LAVIGNE, Hôpital Prive Saint Martin

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): April 18, 2023
• Study Completion (Actual): April 18, 2023

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2020-A02531-38

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