Use of the WALANT Anesthesia Technique for Forefoot Surgery.

Orthopedic Disorder Clinical Trial

— WALANT  

Official title:

Use of the WALANT Anesthesia Technique for Forefoot Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04858048
• Other study ID #: 2020-A02531-38
• Status: Completed
• Start date: January 15, 2021
• Est. completion date: April 18, 2023

Study information

• Verified date: April 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: April 18, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

Procedure:
• Anesthesia
2 types of anesthesia (general and WALANT) performed during the surgery

Locations

Country	Name	City	State
France	Hôpital Privé saint Martin	Caen

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment	Measure of the pain using the VAS pain scale.	Perioperative