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CompletedNCT04858048WALANTUpdated Apr 18, 2024

Use of the WALANT Anesthesia Technique for Forefoot Surgery.

An observational study in Orthopedic Disorder, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-18.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
85
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Orthopedic Disorder
03

In context

Musculoskeletal Diseases

657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.

This study's enrollment of 85 is below the median of 126 across 201 observational studies indexed under Musculoskeletal Diseases.

Browse Musculoskeletal Diseases studies →

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 198 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with scheduled forefoot surgery.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Pregnant or breastfeeding woman
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
85 participants (actual)
Patient registry
No

Groups and cohorts

  • Group with general anesthesia performed during the forefoot surgery

    Procedure: Anesthesia

  • Group with WALANT anesthesia performed during the forefoot surgery

    Procedure: Anesthesia

Interventions

  • ProcedureAnesthesia

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

06

What researchers measure

Primary outcomes

  1. Pain assessment

    Measure of the pain using the VAS pain scale.

    Time frame: Perioperative

07

Study locations

1 site
  • Hôpital Privé saint Martin
    Caen, 14050, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04858048
Lead sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Responsible party
Sponsor
First posted
Apr 26, 2021
Start date
Jan 15, 2021
Primary completion
Apr 18, 2023
Completion
Apr 18, 2023
Last update
Apr 18, 2024

Study contacts

François LAVIGNE
principal investigator · Hôpital Privé Saint Martin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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