Low Dose Spinal Bupivacaine for Total Knee Replacement and Recovery Room Wait Time
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| First Received Date ICMJE | September 28, 2007 | ||||||||||||
| Last Updated Date | April 16, 2009 | ||||||||||||
| Start Date ICMJE | October 2007 | ||||||||||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Time from spinal injection of bupivicaine until recovery room discharge criteria met. [ Time Frame: Until recovery room discharge post surgery ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
Time from spinal injection of bupivicaine until recovery room discharge criteria met. [ Time Frame: Until recovery room discharge post surgery ] | ||||||||||||
| Change History | Complete list of historical versions of study NCT00537472 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 | Low Dose Spinal Bupivacaine for Total Knee Replacement and Recovery Room Wait Time | ||||||||||||
| Official Title ICMJE | Low Dose Spinal Bupivacaine for Total Knee Arthroplasty and Recovery Room Wait Time | ||||||||||||
| Brief Summary | This study plans to investigate whether a reduced dose of bupivacaine (a local anesthetic numbing drug) injected into the spinal space for a total knee replacement will result in a shorter time to discharge from the recovery room while maintaining adequate surgical anesthesia. |
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| Detailed Description | With the doses of bupivacaine currently being used in spinal anesthetics at our institution, patients' sensory blocks are often much higher than needed to achieve adequate surgical anesthesia. This translates into a prolonged waiting period in the recovery room before the level regresses down to the pre-existing standard for discharge to the ward, as well as the pre-existing level before a post-operative nerve block for extended pain relief can be performed. This prolonged period in the recovery room leads to general delays in operating room usage and thus surgical cancellations. The excessive drug doses currently used also put patients at risk for increasing side effects including low blood pressure, slow heart rates, and nausea and vomiting. By using a reduced dose of bupivacaine in a spinal anesthetic for a one sided knee replacement, we hope to significantly reduce the recovery room waiting times until the criteria for recovery room discharge or completion of a post-operative nerve block are met, while still providing adequate surgical anesthesia. Patients will receive either 9 mg (intervention dose) or 13 mg (control dose) of bupivacaine through a spinal injection. Once the patients enter the recovery room after surgery the level of their sensory block will be tested as per usual protocol by the recovery room nurses every 15 minutes until a predefined level has been reached, and the two groups will be compared. |
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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: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| 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 | Completed | ||||||||||||
| Enrollment ICMJE | 140 | ||||||||||||
| Completion Date | December 2008 | ||||||||||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | Not Provided | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Canada | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00537472 | ||||||||||||
| Other Study ID Numbers ICMJE | 6106 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Melanie Jaeger, MD, FRCPC, Queens University and Kingston General Hospital | ||||||||||||
| Study Sponsor ICMJE | Queen's University | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Queen's University | ||||||||||||
| Verification Date | April 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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