The Influence of a Bupivacaine Digital Nerve Block Using Rev G.
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 10, 2012
CompletedFirst Posted
Study publicly available on registry
December 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedApril 10, 2015
April 1, 2015
7 months
December 10, 2012
April 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SpHb (continuous hemoglobin monitor reading) minus tHb (clinical laboratory determined hemoglobin value).
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.
Intermittent (about hourly) hemoglobin checks throughout the surgery.
Study Arms (2)
bupivacaine digital nerve block
EXPERIMENTALPatients 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.
No bupivacaine digital nerve block
NO INTERVENTIONPatients undergoing spine surgery will have a 50/50 chance of being randomized to not receive a bupivacaine 0.25% (2 milliliters total) intermediate-acting digital nerve block.
Interventions
non-therapeutic Bupivacaine digital nerve block to assess effect on accuracy of diagnostic readings
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant or nursing
- Patients who in the study investigators clinical judgement would not be suitable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald D Miller, MD, MS
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2012
First Posted
December 17, 2012
Study Start
December 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
April 10, 2015
Record last verified: 2015-04