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| Tracking Information | |||||||||
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| First Received Date † | December 22, 2005 | ||||||||
| Last Updated Date | October 12, 2006 | ||||||||
| Start Date † | February 2005 | ||||||||
| Current Primary Outcome Measures † |
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| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00269529 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Intraarticular Analgesia After Total Knee Arthroplasty, a Randomised Study | ||||||||
| Official Title † | Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Femoral Block and Extensive Intraoperative Infiltration With Local Anesthetic Supplemented With Intraarticular Bolus the Following Day. | ||||||||
| Brief Summary | The study aims to compare two different kinds of pain treatment after total knee replacement (operation with artificial knee joint): 1) a large local injection in and around the knee, supplemented with injection the day after, or 2) the department's conventional pain treatment consisting of continuous nerve block in the groin. |
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| Detailed Description | Postoperative pain after total knee arthroplasty is moderate to severe and can be difficult to treat. The current use of femoral nerve block by ropivacain pump for 48 hours provides considerable analgesia, but patients often experience slight motor block, inhibiting rehabilitation, and pain in the posterior part of the knee, innervated by the sciatic nerve. This study compares femoral nerve block to a new technique, where ropivacaine, ketorolac and adrenalin is used to infiltrate the tissue in and around the knee joint during surgery, and is injected by an intraarticular catheter at 10 pm on the day of surgery and again at 10 am the day after. Data of pain scores, analgesia consumption, adverse effects and mobilisation is collected for the first four postoperative days. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition † | Arthroplasty, Replacement, Knee | ||||||||
| Intervention † |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 80 | ||||||||
| Completion Date | March 2006 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | Denmark | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00269529 | ||||||||
| Responsible Party | |||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | University of Aarhus | ||||||||
| Collaborators †† |
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| Investigators † |
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| Information Provided By | University of Aarhus | ||||||||
| Verification Date | October 2006 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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