Fracture, AnkleIRBNCT04844372
Impact of Regional Anesthesia on Blood Pressure in Lower Limb Traumatism
An observational study of Fracture, Ankle and Fracture Leg, 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 leg and ankle fractures surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture, Ankle, Fracture Leg
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 29 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: * Surgical revision or surgery for pre-existing infection, tumour * Intubated patient / unconscious patient * Vasopressors before surgery * Haemostasis disorder
Who may be able to join
- ASA I - IV
- Ankle and/or leg fracture
- Operated between january 2016 and december 2020 at Montpellier
Who cannot join
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Regional Anesthesia on Blood Pressure in Lower Limb Traumatism : IRB (Impact of Regional Anesthesia on Blood Pressure)
This study aims to compare the hemodynamic impact of two anaesthetic strategies 'Regional anesthesia' versus 'General anesthesia' in leg and ankle fractures surgery.
Read the detailed description
Leg and/or ankle 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 preserving drugs for GA and exposing less medical staff on patient's airway.
Currently, unlike neuraxial anesthesia, few data deal with impact of peripheral RA and hemodynamic consequences.
The investigators hypothesize that the use of Regional anesthesia reduces the use of intraoperative vasopressor.
After ethical committee approval, a retrospective cohort of patients with lower limb traumatism, in Montpellier's University Hospital, was analyzed from 2016 to 2020. An informational note was given to all patients participating to the study.
- Conditions
- Fracture, Ankle, Fracture Leg
- Keywords
- Surgery for Ankle and/or leg fracture
- Medical subject headings
- Ankle Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
use of vasopressors
use of vasopressors during surgery
Measured: during surgery
Secondary outcomes (3)
Total dose of vasoconstrictor
Total dose of vasoconstrictor administered
Measured: during surgery
Duration of peroperative hypotension
Duration of peroperative hypotension
Measured: during surgery
Post-operative complications
Nausea/vomiting ; Cardiovascular complications ( dysrhythmias, ischaemia, Complications related to regional anesthesia (sciatic nerve paralysis, femoral) haematoma thromboembolism, sepsis, postoperative cognitive disorders);
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start1 Mar 2021
- Primary completion1 Feb 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture, AnkleStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas SURCIN-TSEKOURAS, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844372
- Sponsor's protocol ID
- RECHMPL21_0091
- Acronym
- IRB
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 14 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 Lower Limb Traumatism : IRB (Impact of Regional Anesthesia on Blood Pressure)
- ClinicalTrials.gov ID
- NCT04844372
- Acronym / sponsor ID
- IRB / RECHMPL21_0091
- Conditions
- Fracture, Ankle, Fracture Leg
- Keywords
- Surgery for Ankle and/or leg fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 14 Apr 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 leg and ankle fractures surgery.
Detailed description
Leg and/or ankle 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 preserving drugs for GA and exposing less medical staff on patient's airway.
Currently, unlike neuraxial anesthesia, few data deal with impact of peripheral RA and hemodynamic consequences.
The investigators hypothesize that the use of Regional anesthesia reduces the use of intraoperative vasopressor.
After ethical committee approval, a retrospective cohort of patients with lower limb traumatism, 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
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Surgical revision or surgery for pre-existing infection, tumour * Intubated patient / unconscious patient * Vasopressors before surgery * Haemostasis disorder
Key inclusion criteria (3 listed)
- ASA I - IV
- Ankle and/or leg fracture
- Operated between january 2016 and december 2020 at Montpellier
Key exclusion criteria (1 listed)
- age < 18 years
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
use of vasopressors
Time frame: during surgery
use of vasopressors during surgery
3 secondary outcomes
Total dose of vasoconstrictor
Time frame: during surgery
Duration of peroperative hypotension
Time frame: during surgery
Post-operative complications
Time frame: up to 7 days
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 14 Apr 2022.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Fracture, Ankle
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Recruiting
Investigating Auto Adjusting Dynamic AFO
Lower Limb; Fusion, Congenital, Lower Limb Fracture
Recruiting
Lateral Ankle Treatment
Avulsion Fracture
RecruitingObservational study
Use of Bioresorbable Magnesium Set Screws in Syndesmotic Injuries: a Pilot Study
Syndesmotic Injury, Trimalleolar Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
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.
Nicolas SURCIN-TSEKOURAS, MD principal investigator
University Hospital, Montpellier
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 Fracture, Ankle and Fracture Leg, 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 3 inclusion and 1 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 14 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?
use of vasopressors (time frame: during surgery). 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 14 Apr 2022.