Clinical trial NCT05153902: Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery
Official title: Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery : Comparative Study Using Propensity-score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proximal Humeral Fracture
Keywords: Surgery
General Anesthesia
Regional anesthesia
Hypotension
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgery for Proximal humeral fracture between january 2016 and december 2020

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants requiring vasopressors in peroperative
timeFrame: during surgery (between anaesthethic induction and end of surgical procedure)
Secondary outcomes:
measure: Total dose of vasoconstrictor
timeFrame: during surgery (between anaesthethic induction and end of surgical procedure)
measure: Total time spent on vasopressor
timeFrame: during surgery (between anaesthethic induction and end of surgical procedure)
measure: Intraoperative complications
timeFrame: during surgery (between anaesthethic induction and end of surgical procedure)
measure: Postoperative complications
timeFrame: between surgery and 2 days post-operative
measure: total dose of rescue analgesia
timeFrame: between discharge from operating room and 24h post-operative
measure: Total time spent in the operating room
timeFrame: between arrival in the operating room and discharge from the operating room
measure: Length of stay in duty or ICU
timeFrame: between the day of surgery and up to 1 month
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
References: