Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery

Completed

• Conditions: Proximal Humeral Fracture

• Registration Number: NCT05153902
• 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 proximal humeral fracture surgery.

Detailed Description

Proximal humeral fracture 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 exposing less medical staff on patient's airway.

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

After ethical committee approval, a retrospective cohort of patients with proximal humeral fracture, 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 First Submitted: 2021-10-19
• Study First Submitted QC: 2021-11-29
• Study Start: 2021-12-01
• Study First Posted: 2021-12-10
• Primary Completion: 2022-02-01
• Study Completion: 2022-03-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

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

Inclusion Criteria

• ASA I - IV
• Proximal humeral fracture
• Operated between january 2016 and december 2020
• Emergency surgery

Exclusion Criteria

• Surgical revision or surgery for pre-existing infection, tumour
• Intubated patient / unconscious patient
• Haemostasis disorder
• Haemostasis disorder
• Refusal of the patient

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants requiring vasopressors in peroperative	during surgery (between anaesthethic induction and end of surgical procedure)	Number of Participants who used vasopressors in peroperative

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	between surgery and 2 days post-operative	nausea/vomiting; cardiovascular complications; complications related to regional anesthesia ; postoperative cognitive disorders
Length of stay in duty or ICU	between the day of surgery and up to 1 month	Length of stay in duty or ICU
Total dose of vasoconstrictor	during surgery (between anaesthethic induction and end of surgical procedure)	Total dose of vasoconstrictor
Intraoperative complications	during surgery (between anaesthethic induction and end of surgical procedure)	Intraoperative complications other than hypotension
Total time spent on vasopressor	during surgery (between anaesthethic induction and end of surgical procedure)	Total time spent on vasopressor
total dose of rescue analgesia	between discharge from operating room and 24h post-operative	opioids
Total time spent in the operating room	between arrival in the operating room and discharge from the operating room	Total time spent in the operating room

Trial Locations

Locations (1)

Uh Montpellier; 🇫🇷 Montpellier, France