- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03356704
Combined Plexus Block for Hip Fracture Surgery.
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Adult
- Hip fracture surgery
Exclusion criteria:
- Multiple trauma victims
- Second hip fracture in same patient
- Single shot spinal anesthesia
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
General anaesthesia
Patient who had surgery for femoral neck fracture from January 2014 to December 2016 and had general anesthesia
|
Observational study
|
|
continued spinal anesthesia
Patient who had surgery for femoral neck fracture from January 2014 to December 2016 and had continued spinal anesthesia
|
Observational study
|
|
peripheral nerve blocks
Patient who had surgery for femoral neck fracture from January 2014 to December 2016 and had peripheral nerve blocks
|
Observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative hypotension
Time Frame: 1 day
|
Decrease of at least 30% of mean arterial pressure
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
measure the total consumption of the vasopressive molecules
Time Frame: 1 day
|
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
|
1 day
|
|
Length of stay
Time Frame: 1 day
|
Length of stay
|
1 day
|
|
compare the use of emergency antalgics
Time Frame: 1 day
|
compare the use of emergency antalgics : opioids consumption
|
1 day
|
|
Inhospital mortality
Time Frame: 1 day
|
Inhospital mortality
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Xavier Capdevila, MD, PhD, University Hospital, Montpellier
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL17_0229
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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