We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01750554
First Posted: December 17, 2012
Last Update Posted: April 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
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.

Condition Intervention
Patients Undergoing Spine Surgery Other: intermediate-acting digital nerve block

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Influence of a Bupivacaine Digital Nerve Block With the New Continuous Sensor (Rev G) on the Accuracy of SpHb Monitoring.

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.



Enrollment: 19
Study Start Date: December 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750554


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Ronald D Miller, MD, MS University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01750554     History of Changes
Other Study ID Numbers: 10-00524D
First Submitted: December 10, 2012
First Posted: December 17, 2012
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by University of California, San Francisco:
SpHb; hemoglobin monitoring;bupivacaine digital nerve block

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents