Ignite Creation Date:
2024-05-05 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00537472
Status:
COMPLETED
Last Update Posted:
2009-04-17
First Post:
2007-09-28
Brief Title:
Low Dose Spinal Bupivacaine for Total Knee Replacement and Recovery Room Wait Time
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
Low Dose Spinal Bupivacaine for Total Knee Arthroplasty and Recovery Room Wait Time
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None