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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental |
| |
| II | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose bupivicaine in spinal anesthetic | Drug | Bupivacaine 9 mg intrathecal single shot injection at start of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from spinal injection of bupivicaine until recovery room discharge criteria met. | Until recovery room discharge post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Need for pharmacologic rescue from inadequate spinal block during the procedure. | Until end of surgery | |
| Time from entrance into recovery room until criteria for a recovery room discharge are met | Until recovery room discharge criteria are met |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melanie Jaeger, MD, FRCPSC | Staff anesthesiologist at Kingston General Hospital | Principal Investigator |
| Dale Engen, MD, FRCPSC | Staff anesthesiologist at Kingston General Hospital | Study Director |
| Devin Sydor, MD | Anesthesiology resident at Kingston General Hospital/Queen's University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
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| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000813 | Anilides |
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| Standard dose bupivacaine in spinal anesthetic | Drug | Bupivacaine 13 mg intrathecal single shot injection at start of surgery |
|
| Time from entrance into recovery room until criteria for a femoral nerve block for post-operative pain control are met | Until criteria are met for post operative nerve block in recovery room |
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |