The Influence of a Bupivacaine Digital Nerve Block Using Rev G.
The investigators are proposing to continue investigation to improve the accuracy of the SpHb (continuous hemoglobin monitoring device) by administering an intermediate acting digital nerve block in the finger connected to the SpHb, specifically bupivacaine 0.25% in patients undergoing spine surgery. Bupivacaine is FDA approved and in routine use.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Influence of a Bupivacaine Digital Nerve Block With the New Continuous Sensor (Rev G) on the Accuracy of SpHb Monitoring.|
- SpHb (continuous hemoglobin monitor reading) minus tHb (clinical laboratory determined hemoglobin value). [ Time Frame: Intermittent (about hourly) hemoglobin checks throughout the surgery. ] [ Designated as safety issue: No ]
Use of a longer acting local anesthetic (bupivacaine) for the digital nerve block will result in SpHb (the non-invasive hemoglobin device) being sufficiently accurate for blood transfusion decisions(≤ 1.0 g/dL difference)
To assess if using an intermediate-acting digital nerve block will improve the accuracy of the SpHb readings when compared to a blood hemoglobin level analyzed in the UCSF Clinical Laboratories intermittently during the patient's surgery.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: bupivacaine digital nerve block
Patients undergoing spine surgery will have a 50/50 chance of being randomized to receive a bupivacaine 0.25% (2 milliliters total) digital nerve block.
No Intervention: No bupivacaine digital nerve block
Patients undergoing spine surgery will have a 50/50 chance of being randomized to not receive a bupivacaine 0.25% (2 milliliters total) digital nerve block.
Patients undergoing spine surgery will be randomized to receive (or not) the bupivacaine digital block on the finger attached to the new limited release version of the hemoglobin sensor, RevG. The SpHb reading will be compared to a blood hemoglobin level analyzed in the UCSF Clinical Laboratories.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750554
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Ronald D Miller, MD, MS||University of California, San Francisco|