NCT05153902

Brief Summary

This study aims to compare the hemodynamic impact of two anaesthetic strategies : Regional anesthesia versus General anesthesia in proximal humeral fracture surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

October 19, 2021

Last Update Submit

April 11, 2022

Conditions

Proximal Humeral Fracture

Keywords

SurgeryGeneral AnesthesiaRegional anesthesiaHypotension

Outcome Measures

Primary Outcomes (1)

  • 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 (7)

  • Total dose of vasoconstrictor

    during surgery (between anaesthethic induction and end of surgical procedure)

  • Total time spent on vasopressor

    during surgery (between anaesthethic induction and end of surgical procedure)

  • Intraoperative complications

    during surgery (between anaesthethic induction and end of surgical procedure)

  • Postoperative complications

    between surgery and 2 days post-operative

  • total dose of rescue analgesia

    between discharge from operating room and 24h post-operative

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgery for Proximal humeral fracture between january 2016 and december 2020

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34090, France

Location

MeSH Terms

Conditions

Shoulder FracturesHypotension

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder InjuriesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2021

First Posted

December 10, 2021

Study Start

December 1, 2021

Primary Completion

February 1, 2022

Study Completion

March 1, 2022

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations

FR(1)