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

April 9, 2015 updated by: University of California, San Francisco

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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) intermediate-acting digital nerve block.
Other: intermediate-acting digital nerve block
non-therapeutic Bupivacaine digital nerve block to assess effect on accuracy of diagnostic readings
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) intermediate-acting digital nerve block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SpHb (continuous hemoglobin monitor reading) minus tHb (clinical laboratory determined hemoglobin value).
Time Frame: 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.
Intermittent (about hourly) hemoglobin checks throughout the surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Ronald D Miller, MD, MS, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

December 10, 2012

First Submitted That Met QC Criteria

December 14, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10-00524D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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