- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00150865
Evaluation of Efficacy of Lumbar Plexus Bloc After Hip Surgery
Study of Posterior Lumbar Plexus Block for Pain Relief After Hip Surgery
Compare lumbar plexus block with ropivacaine 0.475%, 0.4 ml/kg to saline. Each group randomized, includes 30 patients. block performed preoperatively Surgery under general anesthesia. Postoperative evaluation of pain (VAS) as first endpoint, and also morphine consumption via PCA device. Follow-up : 24h.
Expectation : sizeable reduction of pain with block, of duration.
Study Overview
Detailed Description
Compare lumbar plexus block (randomized)
- ropivacaine 0.475%, 0.4 ml/kg
- saline 0.4 ml/kg . Each group includes 30 patients.
Block performed preoperatively.
Surgery under general anesthesia (sufentanil, propofol, atracurium ; maintenance : sevoflurane and nitrous oxide in O2. Sufentanil added peroperatively as clinically needed.
Postoperative evaluation of pain (VAS, by an independant blind observer) as first endpoint, and also morphine consumption via PCA device.
Adverse effects (nausea, vomiting, etc) recorded
Follow-up : 24h. Expectation : sizeable reduction of pain with block, of duration.
Study Type
Enrollment
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adults
- ASA 1-3
Exclusion Criteria:
- cognitive impairement
- ASA IV
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
decrease of postoperative pain
|
Secondary Outcome Measures
Outcome Measure |
---|
decrease in morphine consumption
|
duraration of analgesic effect
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: laurent beydon, MD, University Hospital, Angers
- Principal Investigator: ibrahim okais, MD, Clinique St Leonard
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP 02-01
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