Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery

Proximal Humeral Fracture Clinical Trial

— ALR_HUMERUS  

Official title:

Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery : Comparative Study Using Propensity-score

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05153902
• Other study ID #: RECHMPL20_0647
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: March 1, 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 proximal humeral fracture surgery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 1, 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

• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humeral Fracture
• Shoulder Fractures

Locations

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