Low Dose Spinal Bupivacaine for Total Knee Replacement and Recovery Room Wait Time
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Purpose
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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Low Dose Spinal Bupivacaine for Total Knee Arthroplasty and Recovery Room Wait Time |
- 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 ]
- Need for pharmacologic rescue from inadequate spinal block during the procedure. [ Time Frame: Until end of surgery ] [ Designated as safety issue: Yes ]
- Time from entrance into recovery room until criteria for a recovery room discharge are met [ Time Frame: Until recovery room discharge criteria are met ] [ Designated as safety issue: No ]
- Time from entrance into recovery room until criteria for a femoral nerve block for post-operative pain control are met [ Time Frame: Until criteria are met for post operative nerve block in recovery room ] [ Designated as safety issue: No ]
| Enrollment: | 140 |
| Study Start Date: | October 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: I |
Drug: Low dose bupivicaine in spinal anesthetic
Bupivacaine 9 mg intrathecal single shot injection at start of surgery
|
| Active Comparator: II |
Drug: Standard dose bupivacaine in spinal anesthetic
Bupivacaine 13 mg intrathecal single shot injection at start of surgery
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients undergoing elective one-sided total knee replacement for osteoarthritis at our institution where spinal anesthesia has been chosen by the patient and the anesthetist
Exclusion Criteria:
- Contraindications to spinal anesthesia (such as increase pressure in brain, bleeding disorder, serious valvular heart disease, serious infection in the blood or on your lower back, certain neurological disorders such as multiple sclerosis, desire for a general anesthetic)
- Allergies to local anesthetics, morphine or fentanyl
- Both knees being done at same surgery
- Revision of a previous knee replacement
- Knee replacement for reasons other than osteoarthritis (such as rheumatoid arthritis)
- Potential for difficult intubation in case of need for general anesthetic
- Patients under 150 cm or over 200 cm
- BMI greater than 40
- Lack of patient consent or patient refusal
Contacts and Locations| Canada, Ontario | |
| Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 2V7 | |
| 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 |
More Information
No publications provided
| Responsible Party: | Melanie Jaeger, MD, FRCPC, Queens University and Kingston General Hospital |
| ClinicalTrials.gov Identifier: | NCT00537472 History of Changes |
| Other Study ID Numbers: | 6106 |
| Study First Received: | September 28, 2007 |
| Last Updated: | April 16, 2009 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Queen's University:
|
Bupivacaine spinal anesthesia total knee arthroplasty |
Additional relevant MeSH terms:
|
Anesthetics Bupivacaine Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Anesthetics, Local Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013