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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 4, 2008 | ||||
| Last Updated Date | May 12, 2009 | ||||
| Start Date ICMJE | October 2007 | ||||
| Estimated Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Total PCA opioid consumption [ Time Frame: 72 hours ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00616850 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Time to first flatus [ Time Frame: 72 hours postoperatively ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment of Postoperative Pain After Total Knee Arthroplasy Using Intravenous Lidocaine Infusion | ||||
| Official Title ICMJE | Treatment of Postoperative Pain After Total Knee Arthroplasty Using Intravenous Lidocaine Infusion in Combination With Patient Controlled Analgesia Versus Continuous Femoral Block Catheter in Combination With Patient Controlled Analgesia: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Study. | ||||
| Brief Summary | Total knee replacement is often associated with severe postoperative pain, especially in the first 24 hours. Patient controlled analgesia (PCA) and continuous femoral block with PCA are commonly used to treat postoperative pain after total knee arthroplasty. However, PCAs use opioids. Opioids are excellent painkillers but their use is hampered by side effects such as nausea, vomiting, bowel dysfunction, urinary retention, pruritus, sedation and respiratory depression. We propose to test the hypothesis that adding a low dose lidocaine infusion to PCAs will lower the amount of opioids that these patients receive, thereby improving patient safety while still providing adequate analgesia. In addition, continuous femoral block has been shown to provide superior postoperative pain control when compared to morphine PCA. Therefore, postoperative pain levels of study subjects will be compared to those subjects who receive a combination of a continuous femoral block catheter with a PCA. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Factorial Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Total Knee Arthroplasty | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| 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 ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 99 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00616850 | ||||
| Responsible Party | Michelle Schlunt, M.D., Loma Linda University Medical Center, Department of Anesthesia | ||||
| Study ID Numbers ICMJE | 57175 | ||||
| Study Sponsor ICMJE | Loma Linda University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Loma Linda University | ||||
| Verification Date | May 2009 | ||||
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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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