The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty
Recruitment status was Not yet recruiting
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| First Received Date ICMJE | July 25, 2008 | ||||||||
| Last Updated Date | July 25, 2008 | ||||||||
| Start Date ICMJE | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Pain, measured by the 11-point numerical pain rating scale [ Time Frame: Post-operatively for three days then again at follow-up ] [ Designated as safety issue: No ] | ||||||||
| 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 | The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty | ||||||||
| Official Title ICMJE | The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty | ||||||||
| Brief Summary | The main purpose of this study is to determine if there is improvement in pain and other patient outcomes when using a continuous wound analgesia system after total knee replacement, compared to usual methods of pain control. Another purpose is to determine if the system makes it easier for nurses to care for these patients. |
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| Detailed Description | Continuous local wound infusion analgesia is a relatively new way of managing post-operative pain, whereby a local anesthetic is continuously infused into the surgical area. Some studies and users have reported decreased pain, decreased opioid use, decreased post-operative nausea and vomiting, decreased length of stay, and improved patient and caregiver satisfaction with the use of continuous local wound infusion analgesia, when compared to placebo, or usual care, in arthroplasty and other surgical interventions. Hypotheses: Primary: The On-Q PainBuster (continuous wound infusion analgesia) in TKA will result in improved patient pain control, compared to usual care. Secondary:
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Total Knee Arthroplasty | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| 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 | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 69 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00724074 | ||||||||
| Other Study ID Numbers ICMJE | garnett | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Dr. Gordon Arnett, Capital Health | ||||||||
| Study Sponsor ICMJE | Capital Health, Canada | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Capital Health, Canada | ||||||||
| Verification Date | July 2008 | ||||||||
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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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