Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty
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| Tracking Information | |||||
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| First Received Date ICMJE | November 21, 2007 | ||||
| Last Updated Date | August 5, 2011 | ||||
| Start Date ICMJE | November 2007 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pain at Rest (VAS) [ Time Frame: 48 hours postoperative ] [ Designated as safety issue: No ] VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain. |
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| Original Primary Outcome Measures ICMJE |
opioid use [ Time Frame: 48 hours postoperative ] | ||||
| Change History | Complete list of historical versions of study NCT00562627 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty | ||||
| Official Title ICMJE | Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty | ||||
| Brief Summary | Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge. The aim of this study is to:
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| Detailed Description | Total knee arthroplasty (TKA) is increasingly common in the treatment of knee osteoarthritis. TKA is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge. Continuous epidural analgesia is often used for controlling pain after TKA. Recent studies describe a new method for pain control after total knee arthroplasty which consists of local infiltration with local anesthetics and adrenaline. This infiltrations can be combined with ketorolac and/or morphine. The aim of this study is to:
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Osteoarthritis of the Knee | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Spreng UJ, Dahl V, Hjall A, Fagerland MW, Ræder J. High-volume local infiltration analgesia combined with intravenous or local ketorolac+morphine compared with epidural analgesia after total knee arthroplasty. Br J Anaesth. 2010 Nov;105(5):675-82. Epub 2010 Aug 24. | ||||
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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 | 102 | ||||
| Completion Date | July 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| 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 | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00562627 | ||||
| Other Study ID Numbers ICMJE | 2007-003030-41, EudraCT 2007-003030-41, REK 1.2007.1603 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Ulrich Johannes Spreng, Asker and Baerum Hospital | ||||
| Study Sponsor ICMJE | Asker & Baerum Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Asker & Baerum Hospital | ||||
| Verification Date | August 2011 | ||||
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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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