Hip FracturesNCT03356704
Combined Plexus Block for Hip Fracture Surgery.
An observational study of Hip Fractures, run by University Hospital, Montpellier.
Trial summary
Hip fracture surgery requires high risk anesthetic procedure for elderly patients (1). General anesthesia, continuous spinal anesthesia and peripheral nerve blocks are three anesthetic techniques possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures
- How many people
- 593 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2016to 26 Oct 2017
- 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
- Adult, Older adult
Study population: All adults patients operated for hip fracture between 1 January 2015 and 31 December 2016.
Who may be able to join
- Adult
- Hip fracture surgery
Who cannot join
- Multiple trauma victims
- Second hip fracture in same patient
- Single shot spinal anesthesia
About this study
Official title: Is the Combined Plexus Block a Real Alternative for Hip Fracture Surgery in the Elderly? A Comparison With General Anesthesia and Continuous Spinal Anesthesia Using a Propensity Score in a Retrospective Cohort Study.
Hip fracture surgery requires high risk anesthetic procedure for elderly patients (1). General anesthesia, continuous spinal anesthesia and peripheral nerve blocks are three anesthetic techniques possible. Continuous spinal anesthesia has proven its efficacity to provide an intraoperative haemodynamic stability wich guarantees good patients outcomes (2), in comparison with general anesthesia but there is poor evidence in the literature concerning the use of peripheral nerve blocks.
The primary objective of this study was to compare intraoperative haemodynamic stability provides by peripheral nerve block versus general anesthesia and continuous spinal anesthesia.
Secondary outcomes included : use of vasoactive drugs, opioids consumption, lengh of stay and inhospital mortality.
Read the detailed description
After receiving the ethic approval from the "CERAR", the investigators retrospectively identified all patients who underwent hip fracture surgery from January 1 2015, to December 31, 2016 in the CHU of Montpellier. The exclusion criteria were: multiple trauma victims, two hip fractures in the same patient and single shot spinal anesthesia. In our institution the investigators used to perform three types of anesthesia: general anesthesia (GA), continuous spinal anesthesia (CSA) and combined plexus blocks (CPB). The investigators therefore made three groups GA, CSA and CPB and used a propensity score to make these groups comparable. The matching criteria were age, arterial hypertension, ASA status, Frailty score, chronic cardiac failure and type of surgery.
- Conditions
- Hip Fractures
- Being tested
- no intervention
- Keywords
- adults
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| General anaesthesia | Patient who had surgery for femoral neck fracture from January 2014 to December 2016 and had general anesthesia Receives: Other: no intervention | |
| continued spinal anesthesia | Patient who had surgery for femoral neck fracture from January 2014 to December 2016 and had continued spinal anesthesia Receives: Other: no intervention | |
| peripheral nerve blocks | Patient who had surgery for femoral neck fracture from January 2014 to December 2016 and had peripheral nerve blocks Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative hypotension
Decrease of at least 30% of mean arterial pressure
Measured: 1 day
Secondary outcomes (4)
measure the total consumption of the vasopressive molecules
measure the total consumption of the vasopressive molecules (necessary when the voltage drops by more than 30% compared to the average reference voltage) : Use of vasoactive drugs
Measured: 1 day
Length of stay
Length of stay
Measured: 1 day
compare the use of emergency antalgics
compare the use of emergency antalgics : opioids consumption
Measured: 1 day
Inhospital mortality
Inhospital mortality
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start31 Aug 2016
- Primary completion1 Feb 2017
- Study completion26 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- 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
- 593 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Capdevila, MD, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356704
- Sponsor's protocol ID
- RECHMPL17_0229
- Status last verified
- Oct 2017
- First submitted
- 26 Oct 2017
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Mounet B, Choquet O, Swisser F, Biboulet P, Bernard N, Bringuier S, Capdevila X. Impact of multiple nerves blocks anaesthesia on intraoperative hypotension and mortality in hip fracture surgery intermediate-risk elderly patients: A propensity score-matched comparison with spinal and general anaesthesia. Anaesth Crit Care Pain Med. 2021 Aug;40(4):100924. doi: 10.1016/j.accpm.2021.100924. Epub 2021 Jul 1.
PubMed 34217841
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Combined Plexus Block a Real Alternative for Hip Fracture Surgery in the Elderly? A Comparison With General Anesthesia and Continuous Spinal Anesthesia Using a Propensity Score in a Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT03356704
- Acronym / sponsor ID
- RECHMPL17_0229
- Conditions
- Hip Fractures
- Keywords
- adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 593 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 31 Aug 2016 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 26 Oct 2017 (actual)
- First posted
- 29 Nov 2017 (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.
Hip fracture surgery requires high risk anesthetic procedure for elderly patients (1). General anesthesia, continuous spinal anesthesia and peripheral nerve blocks are three anesthetic techniques possible. Continuous spinal anesthesia has proven its efficacity to provide an intraoperative haemodynamic stability wich guarantees good patients outcomes (2), in comparison with general anesthesia but there is poor evidence in the literature concerning the use of peripheral nerve blocks.
The primary objective of this study was to compare intraoperative haemodynamic stability provides by peripheral nerve block versus general anesthesia and continuous spinal anesthesia.
Secondary outcomes included : use of vasoactive drugs, opioids consumption, lengh of stay and inhospital mortality.
Detailed description
After receiving the ethic approval from the "CERAR", the investigators retrospectively identified all patients who underwent hip fracture surgery from January 1 2015, to December 31, 2016 in the CHU of Montpellier. The exclusion criteria were: multiple trauma victims, two hip fractures in the same patient and single shot spinal anesthesia. In our institution the investigators used to perform three types of anesthesia: general anesthesia (GA), continuous spinal anesthesia (CSA) and combined plexus blocks (CPB). The investigators therefore made three groups GA, CSA and CPB and used a propensity score to make these groups comparable. The matching criteria were age, arterial hypertension, ASA status, Frailty score, chronic cardiac failure and type of surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General anaesthesia | – | Other: no interventionPatient who had surgery for femoral neck fracture from January 2014 to December 2016 and had general anesthesia |
| continued spinal anesthesia | – | Other: no interventionPatient who had surgery for femoral neck fracture from January 2014 to December 2016 and had continued spinal anesthesia |
| peripheral nerve blocks | – | Other: no interventionPatient who had surgery for femoral neck fracture from January 2014 to December 2016 and had peripheral nerve blocks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adults patients operated for hip fracture between 1 January 2015 and 31 December 2016.
Key inclusion criteria (2 listed)
- Adult
- Hip fracture surgery
Key exclusion criteria (3 listed)
- Multiple trauma victims
- Second hip fracture in same patient
- Single shot spinal anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionObservational study | Other | General anaesthesia, continued spinal anesthesia, peripheral nerve blocks |
Primary outcome
Intraoperative hypotension
Time frame: 1 day
Decrease of at least 30% of mean arterial pressure
4 secondary outcomes
measure the total consumption of the vasopressive molecules
Time frame: 1 day
Length of stay
Time frame: 1 day
compare the use of emergency antalgics
Time frame: 1 day
Inhospital mortality
Time frame: 1 day
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 19 Jul 2018.
- Derived from this study: PubMed 34217841Mounet B, Choquet O, Swisser F, Biboulet P, Bernard N, Bringuier S, Capdevila X. Impact of multiple nerves blocks anaesthesia on intraoperative hypotension and mortality in hip fracture surgery intermediate-risk elderly patients: A propensity score-matched comparison with spinal and general anaesthesia. Anaesth Crit Care Pain Med. 2021 Aug;40(4):100924. doi: 10.1016/j.accpm.2021.100924. Epub 2021 Jul 1.
- Individual participant dataSharing planned: Undecided. NC
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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.
Xavier Capdevila, MD, PhD study director
University Hospital, Montpellier
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures, run by University Hospital, Montpellier.
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 2 inclusion and 3 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 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Intraoperative hypotension (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03356704, which also lists 1 linked publication.
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 19 Jul 2018.