Impact of Regional Anesthesia on Blood Pressure in Humera... | NCT05153902

Studies
Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery

NCT05153902

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Apr 12, 2022Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Proximal Humeral Fracture

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Actual

Primary Completion Date

Feb 1, 2022Actual

Completion Date

Mar 1, 2022Actual

First Submitted Date

Oct 19, 2021

First Submission Date that Met QC Criteria

Nov 29, 2021

First Posted Date

Dec 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2022

Last Update Posted Date

Apr 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Total dose of vasoconstrictor	Total dose of vasoconstrictor	during surgery (between anaesthethic induction and end of surgical procedure)
Total time spent on vasopressor	Total time spent on vasopressor

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Surgery for Proximal humeral fracture between january 2016 and december 2020

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uh Montpellier		Montpellier		34090	France

Condition Browse Module

MeSH Terms

ID	Term
D012784	Shoulder Fractures
D007022	Hypotension

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D000070599	Shoulder Injuries
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided