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ALR_HUMERUS: Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT05153902
Collaborator
(none)
250
Enrollment
1
Location
3
Actual Duration (Months)
84.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery : Comparative Study Using Propensity-score
    Actual Study Start Date :
    Dec 1, 2021
    Actual Primary Completion Date :
    Feb 1, 2022
    Actual Study Completion Date :
    Mar 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Total dose of vasoconstrictor [during surgery (between anaesthethic induction and end of surgical procedure)]

      Total dose of vasoconstrictor

    2. Total time spent on vasopressor [during surgery (between anaesthethic induction and end of surgical procedure)]

      Total time spent on vasopressor

    3. Intraoperative complications [during surgery (between anaesthethic induction and end of surgical procedure)]

      Intraoperative complications other than hypotension

    4. Postoperative complications [between surgery and 2 days post-operative]

      nausea/vomiting; cardiovascular complications; complications related to regional anesthesia ; postoperative cognitive disorders

    5. total dose of rescue analgesia [between discharge from operating room and 24h post-operative]

      opioids

    6. 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

    7. Length of stay in duty or ICU [between the day of surgery and up to 1 month]

      Length of stay in duty or ICU

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uh Montpellier Montpellier France 34090

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT05153902
    Other Study ID Numbers:
    • RECHMPL20_0647
    First Posted:
    Dec 10, 2021
    Last Update Posted:
    Apr 12, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Surgery
    General Anesthesia
    Regional anesthesia
    Hypotension
    Additional relevant MeSH terms:
    Fractures, Bone
    Humeral Fractures
    Shoulder Fractures

    Study Results

    No Results Posted as of Apr 12, 2022