Proximal Humeral FractureALR_HUMERUSNCT05153902
Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery
An observational study of Proximal Humeral Fracture, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This study aims to compare the hemodynamic impact of two anaesthetic strategies : Regional anesthesia versus General anesthesia in proximal humeral fracture surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Humeral Fracture
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgery for Proximal humeral fracture between january 2016 and december 2020
Who may be able to join
- ASA I - IV
- Proximal humeral fracture
- Operated between january 2016 and december 2020
- Emergency surgery
Who cannot join
- Surgical revision or surgery for pre-existing infection, tumour
- Intubated patient / unconscious patient
- Haemostasis disorder
- Haemostasis disorder
- Refusal of the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery : Comparative Study Using Propensity-score
This study aims to compare the hemodynamic impact of two anaesthetic strategies : Regional anesthesia versus General anesthesia in proximal humeral fracture surgery.
Read the 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.
- Conditions
- Proximal Humeral Fracture
- Keywords
- Surgery, General Anesthesia, Regional anesthesia, Hypotension
- Medical subject headings
- Shoulder Fractures, Hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants requiring vasopressors in peroperative
Number of Participants who used vasopressors in peroperative
Measured: during surgery (between anaesthethic induction and end of surgical procedure)
Secondary outcomes (7)
Total dose of vasoconstrictor
Total dose of vasoconstrictor
Measured: during surgery (between anaesthethic induction and end of surgical procedure)
Total time spent on vasopressor
Total time spent on vasopressor
Measured: during surgery (between anaesthethic induction and end of surgical procedure)
Intraoperative complications
Intraoperative complications other than hypotension
Measured: during surgery (between anaesthethic induction and end of surgical procedure)
Postoperative complications
nausea/vomiting; cardiovascular complications; complications related to regional anesthesia ; postoperative cognitive disorders
Measured: between surgery and 2 days post-operative
total dose of rescue analgesia
opioids
Measured: between discharge from operating room and 24h post-operative
Total time spent in the operating room
Total time spent in the operating room
Measured: between arrival in the operating room and discharge from the operating room
Length of stay in duty or ICU
Length of stay in duty or ICU
Measured: between the day of surgery and up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start1 Dec 2021
- Primary completion1 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humeral FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153902
- Sponsor's protocol ID
- RECHMPL20_0647
- Acronym
- ALR_HUMERUS
- Status last verified
- Apr 2022
- First submitted
- 19 Oct 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery : Comparative Study Using Propensity-score
- ClinicalTrials.gov ID
- NCT05153902
- Acronym / sponsor ID
- ALR_HUMERUS / RECHMPL20_0647
- Conditions
- Proximal Humeral Fracture
- Keywords
- Surgery, General Anesthesia, Regional anesthesia, Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgery for Proximal humeral fracture between january 2016 and december 2020
Key inclusion criteria (4 listed)
- ASA I - IV
- Proximal humeral fracture
- Operated between january 2016 and december 2020
- Emergency surgery
Key exclusion criteria (5 listed)
- Surgical revision or surgery for pre-existing infection, tumour
- Intubated patient / unconscious patient
- Haemostasis disorder
- Haemostasis disorder
- Refusal of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Total dose of vasoconstrictor
Time frame: during surgery (between anaesthethic induction and end of surgical procedure)
Total time spent on vasopressor
Time frame: during surgery (between anaesthethic induction and end of surgical procedure)
Intraoperative complications
Time frame: during surgery (between anaesthethic induction and end of surgical procedure)
Postoperative complications
Time frame: between surgery and 2 days post-operative
total dose of rescue analgesia
Time frame: between discharge from operating room and 24h post-operative
Total time spent in the operating room
Time frame: between arrival in the operating room and discharge from the operating room
Length of stay in duty or ICU
Time frame: between the day of surgery and up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Humeral Fracture, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants requiring vasopressors in peroperative (time frame: during surgery (between anaesthethic induction and end of surgical procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.