NCT04858048

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2023

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

2.3 years

First QC Date

April 15, 2021

Last Update Submit

April 17, 2024

Conditions

Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

  • Pain assessment

    Measure of the pain using the VAS pain scale.

    Perioperative

Study Arms (2)

Group with general anesthesia performed during the forefoot surgery

Procedure: Anesthesia

Group with WALANT anesthesia performed during the forefoot surgery

Procedure: Anesthesia

Interventions

AnesthesiaPROCEDURE

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

Group with WALANT anesthesia performed during the forefoot surgeryGroup with general anesthesia performed during the forefoot surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with scheduled forefoot surgery.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Privé saint Martin

Caen, 14050, France

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Anesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • François LAVIGNE

    Hôpital Privé Saint Martin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2021

First Posted

April 26, 2021

Study Start

January 15, 2021

Primary Completion

April 18, 2023

Study Completion

April 18, 2023

Last Updated

April 18, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)