IRB: Impact of Regional Anesthesia on Blood Pressure in Lower Limb Traumatism

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT04844372

Collaborator

(none)

250

Enrollment

Location

12.9

Actual Duration (Months)

19.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fracture, Ankle Fracture Leg

Detailed Description

Leg and/or ankle surgery is frequently performed under General Anesthesia (GA). GA is frequently associated with a high risk of hypotension with significant consequences.

Regional anesthesia could be an interesting alternative to GA in order to limit hemodynamic consequences, especially in elderly patients.

Furthermore, in the current state of Covid 19 crisis, regional anesthesia could provide solutions in preserving drugs for GA and exposing less medical staff on patient's airway.

Currently, unlike neuraxial anesthesia, few data deal with impact of peripheral RA and hemodynamic consequences.

The investigators hypothesize that the use of Regional anesthesia reduces the use of intraoperative vasopressor.

After ethical committee approval, a retrospective cohort of patients with lower limb traumatism, in Montpellier's University Hospital, was analyzed from 2016 to 2020. An informational note was given to all patients participating to the study.

Study Design

Study Type:

Observational

Actual Enrollment :

250 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Impact of Regional Anesthesia on Blood Pressure in Lower Limb Traumatism : IRB (Impact of Regional Anesthesia on Blood Pressure)

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Feb 1, 2022

Actual Study Completion Date :

Mar 29, 2022

Outcome Measures

Primary Outcome Measures

use of vasopressors [during surgery]
use of vasopressors during surgery

Secondary Outcome Measures

Total dose of vasoconstrictor [during surgery]
Total dose of vasoconstrictor administered
Duration of peroperative hypotension [during surgery]
Duration of peroperative hypotension
Post-operative complications [up to 7 days]
Nausea/vomiting ; Cardiovascular complications ( dysrhythmias, ischaemia, Complications related to regional anesthesia (sciatic nerve paralysis, femoral) haematoma thromboembolism, sepsis, postoperative cognitive disorders);

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria

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

Exclusion criteria

age < 18 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uhmontpellier	Montpellier		France	34295

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

Principal Investigator: Nicolas SURCIN-TSEKOURAS, MD, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT04844372

Other Study ID Numbers:

RECHMPL21_0091

First Posted:

Apr 14, 2021

Last Update Posted:

Apr 14, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Montpellier

Surgery for Ankle and/or leg fracture

Additional relevant MeSH terms:

Fractures, Bone

Ankle Fractures

Study Results

No Results Posted as of Apr 14, 2022