The Influence of a Bupivacaine Digital Nerve Block Using Rev G.

Not Applicable

Completed

• Conditions: Patients Undergoing Spine Surgery
• Interventions: Other: intermediate-acting digital nerve block

• Registration Number: NCT01750554
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-14
• Study First Posted: 2012-12-17
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Male or female 18 years of age or older
• American Society of Anesthesiologists classification 1, 2 or 3
• Scheduled to undergo spine or hip surgery

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Exclusion Criteria

• Pregnant or nursing
• Patients who in the study investigators clinical judgement would not be suitable

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine digital nerve block	intermediate-acting 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) intermediate-acting digital nerve block.

Primary Outcome Measures

Name	Time	Method
SpHb (continuous hemoglobin monitor reading) minus tHb (clinical laboratory determined hemoglobin value).	Intermittent (about hourly) hemoglobin checks throughout the surgery.	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States