Postoperative Analgesia After Total Hip Replacement
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | March 29, 2007 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00219921 on ClinicalTrials.gov Archive Site | ||||
| 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 | Postoperative Analgesia After Total Hip Replacement | ||||
| Official Title ICMJE | Postoperative Analgesia After Total Hip Replacement | ||||
| Brief Summary | There are several treatments for postoperative pain after Hip Replacement Surgery. However, some require an intravenous line which may interfere with rehabilitation after surgery. This study aims to evaluate which method of pain treatment is best after Hip Replacement Surgery. Patients will either receive pain treatment at surgery, continuous intravenous pain treatment, or both. In the first two days after surgery, patients will frequently be asked to rate their pain, and use of other pain medication will be monitored. |
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| Detailed Description | This is a three-group randomized placebo-controlled double blind trial to assess which postoperative analgesia is best after total hip replacement. The conventional analgesia includes both intrathecal morphine at surgery and Patient Controlled Analgesia (PCA) with morphine in the first 48 hours after surgery. This will be compared with two experimental groups which will receive either intrathecal morphine and PCA with placebo or intrathecal placebo and PCA with morphine. Escape medication with intramuscular morphine is available in all groups. A total of 120 patients will be randomized. VAS- score at rest and with movement will be recorded every three hours for the first 48 hours after surgery, as well as PCA-bolussum and Morphine IM. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Total Hip Replacement | ||||
| Intervention ICMJE |
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| 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 | 120 | ||||
| Completion Date | February 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years to 85 Years | ||||
| 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 | NCT00219921 | ||||
| Other Study ID Numbers ICMJE | LTC-349-030905 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Rijnstate Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Rijnstate Hospital | ||||
| Verification Date | March 2007 | ||||
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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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