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Completed

NCT Number: NCT01750554

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

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.

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Key information

Conditions

Patients Undergoing Spine Surgery

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intermediate-acting digital nerve block

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 17, 2012
Registry last updated
Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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