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Completed

NCT Number: NCT05153902

Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery

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

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Key information

Conditions

Proximal Humeral Fracture Cardiovascular Diseases Fractures, Bone Hypotension Shoulder Fractures Shoulder Injuries Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34090, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Participants requiring vasopressors in peroperative

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

    Number of Participants who used vasopressors in peroperative

Secondary outcomes

  1. Total dose of vasoconstrictor

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

    Total dose of vasoconstrictor

  2. Total time spent on vasopressor

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

    Total time spent on vasopressor

  3. Intraoperative complications

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

    Intraoperative complications other than hypotension

  4. Postoperative complications

    Time frame: 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

    Time frame: between discharge from operating room and 24h post-operative

    opioids

  6. Total time spent in the operating room

    Time frame: 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

    Time frame: between the day of surgery and up to 1 month

    Length of stay in duty or ICU

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: ALR_HUMERUS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2021
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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