Use of the WALANT Anesthesia Technique for Forefoot Surgery.

NCT ID: NCT04858048

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-15

Study Completion Date

2023-04-18

Brief Summary

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

Detailed Description

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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.

Conditions

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Orthopedic Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group with general anesthesia performed during the forefoot surgery

Anesthesia

Intervention Type PROCEDURE

2 types of anesthesia (general and WALANT) performed during the surgery

Group with WALANT anesthesia performed during the forefoot surgery

Anesthesia

Intervention Type PROCEDURE

2 types of anesthesia (general and WALANT) performed during the surgery

Interventions

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Anesthesia

2 types of anesthesia (general and WALANT) performed during the surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François LAVIGNE

Role: PRINCIPAL_INVESTIGATOR

Hôpital Privé Saint Martin

Locations

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Hôpital Privé saint Martin

Caen, , France

Site Status

Countries

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France

Other Identifiers

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2020-A02531-38

Identifier Type: -

Identifier Source: org_study_id

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