Evaluation of Efficacy of Lumbar Plexus Bloc After Hip Surgery
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| First Received Date ICMJE | September 7, 2005 | ||||||||
| Last Updated Date | September 7, 2005 | ||||||||
| Start Date ICMJE | September 2001 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
decrease of postoperative pain | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation of Efficacy of Lumbar Plexus Bloc After Hip Surgery | ||||||||
| Official Title ICMJE | Study of Posterior Lumbar Plexus Block for Pain Relief After Hip Surgery | ||||||||
| Brief Summary | 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. |
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| Detailed Description | Compare lumbar plexus block (randomized)
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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: ropivacaine | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 60 | ||||||||
| Completion Date | March 2002 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Not Provided | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00150865 | ||||||||
| Other Study ID Numbers ICMJE | CP 02-01 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | University Hospital, Angers | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Angers | ||||||||
| Verification Date | September 2005 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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