NCT04844372

Brief Summary

This study aims to compare the hemodynamic impact of two anaesthetic strategies 'Regional anesthesia' versus 'General anesthesia' in leg and ankle fractures surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2022

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

April 6, 2021

Last Update Submit

April 13, 2022

Conditions

Fracture, AnkleFracture Leg

Keywords

Surgery for Ankle and/or leg fracture

Outcome Measures

Primary Outcomes (1)

  • use of vasopressors

    use of vasopressors during surgery

    during surgery

Secondary Outcomes (3)

  • Total dose of vasoconstrictor

    during surgery

  • Duration of peroperative hypotension

    during surgery

  • Post-operative complications

    up to 7 days

Eligibility Criteria

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

* Surgical revision or surgery for pre-existing infection, tumour * Intubated patient / unconscious patient * Vasopressors before surgery * Haemostasis disorder

You may qualify if:

  • ASA I - IV
  • Ankle and/or leg fracture
  • Operated between january 2016 and december 2020 at Montpellier

You may not qualify if:

  • \- age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Study Officials

  • Nicolas SURCIN-TSEKOURAS, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 14, 2021

Study Start

March 1, 2021

Primary Completion

February 1, 2022

Study Completion

March 29, 2022

Last Updated

April 14, 2022

Record last verified: 2022-04

Locations

FR(1)