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

The Influence of a Bupivacaine Digital Nerve Block With the New Continuous Sensor (Rev G) on the Accuracy of SpHb Monitoring.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01750554
Enrollment
19
Registered
2012-12-17
Start date
2012-12-31
Completion date
2013-07-31
Last updated
2015-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Undergoing Spine Surgery

Keywords

SpHb; hemoglobin monitoring;bupivacaine digital nerve block

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.

Interventions

OTHERintermediate-acting digital nerve block

non-therapeutic Bupivacaine digital nerve block to assess effect on accuracy of diagnostic readings

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026