Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Queen's University |
---|---|
Information provided by: | Queen's University |
ClinicalTrials.gov Identifier: | NCT00537472 |
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.
Condition | Intervention |
---|---|
Spinal Anesthesia Total Knee Arthroplasty |
Drug: Low dose bupivicaine in spinal anesthetic Drug: Standard dose bupivacaine in spinal anesthetic |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Low Dose Spinal Bupivacaine for Total Knee Arthroplasty and Recovery Room Wait Time |
Estimated Enrollment: | 140 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
I: Experimental |
Drug: Low dose bupivicaine in spinal anesthetic
Bupivacaine 9 mg intrathecal single shot injection at start of surgery
|
II: Active Comparator |
Drug: Standard dose bupivacaine in spinal anesthetic
Bupivacaine 13 mg intrathecal single shot injection at start of surgery
|
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Devin Sydor, MD | 613-548-7827 | devsyd@gmail.com |
Contact: Melanie Jaeger, MD, FRCPSC | 613-548-7827 | jaegerm@kgh.kari.net |
Canada, Ontario | |
Kingston General Hospital | Recruiting |
Kingston, Ontario, Canada, K7L 2V7 | |
Principal Investigator: Melanie Jaeger, MD, FRCPSC | |
Sub-Investigator: Dale Engen, MD, FRCPSC | |
Sub-Investigator: Devin Sydor, MD |
Principal Investigator: | Melanie Jaeger, MD, FRCPSC | Staff anesthesiologist at Kingston General Hospital |
Study Director: | Dale Engen, MD, FRCPSC | Staff anesthesiologist at Kingston General Hospital |
Study Director: | Devin Sydor, MD | Anesthesiology resident at Kingston General Hospital/Queen's University |
Responsible Party: | Queens University and Kingston General Hospital ( Melanie Jaeger, MD, FRCPC ) |
Study ID Numbers: | 6106 |
Study First Received: | September 28, 2007 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00537472 |
Health Authority: | Canada: Ethics Review Committee |
Bupivacaine spinal anesthesia total knee arthroplasty |
Bupivacaine |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Anesthetics |
Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |