Impact of Regional Anesthesia on Blood Pressure in Lower Limb Traumatism

Completed

• Conditions: Fracture, Ankle; Fracture Leg

• Registration Number: NCT04844372
• Lead Sponsor: University Hospital, Montpellier

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.

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 Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-14
• Primary Completion: 2022-02-01
• Study Completion: 2022-03-29
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
use of vasopressors	during surgery	use of vasopressors during surgery

Secondary Outcome Measures

Name	Time	Method
Total dose of vasoconstrictor	during surgery	Total dose of vasoconstrictor administered
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);
Duration of peroperative hypotension	during surgery	Duration of peroperative hypotension

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France