Clinical Trials Directory

Trials / Completed

CompletedNCT00537472

Low Dose Spinal Bupivacaine for Total Knee Replacement and Recovery Room Wait Time

Low Dose Spinal Bupivacaine for Total Knee Arthroplasty and Recovery Room Wait Time

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
140 (actual)
Sponsor
Queen's University · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGLow dose bupivicaine in spinal anestheticBupivacaine 9 mg intrathecal single shot injection at start of surgery
DRUGStandard dose bupivacaine in spinal anestheticBupivacaine 13 mg intrathecal single shot injection at start of surgery

Timeline

Start date
2007-10-01
Primary completion
2008-12-01
Completion
2008-12-01
First posted
2007-10-01
Last updated
2009-04-17

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT00537472. Inclusion in this directory is not an endorsement.