Impact of Regional Anesthesia on Blood Pressure in Lower Limb Traumatism

Fracture, Ankle Clinical Trial

— IRB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04844372
• Other study ID #: RECHMPL21_0091
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: March 29, 2022

Study information

• Verified date: April 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 29, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• ASA I - IV

• Ankle and/or leg fracture

• Operated between january 2016 and december 2020 at Montpellier

Exclusion criteria

• age < 18 years

Related Conditions & MeSH terms

• Ankle Fractures
• Fracture Leg
• Fracture, Ankle
• Fractures, Bone

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	use of vasopressors	use of vasopressors during surgery	during surgery
Secondary	Total dose of vasoconstrictor	Total dose of vasoconstrictor administered	during surgery
Secondary	Duration of peroperative hypotension	Duration of peroperative hypotension	during surgery
Secondary	Post-operative complications	Nausea/vomiting ; Cardiovascular complications ( dysrhythmias, ischaemia, Complications related to regional anesthesia (sciatic nerve paralysis, femoral) haematoma thromboembolism, sepsis, postoperative cognitive disorders);	up to 7 days