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

NCT ID: NCT01750554

Last Updated: 2015-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Patients Undergoing Spine Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

intermediate-acting digital nerve block

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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intermediate-acting digital nerve block

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald D Miller, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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10-00524D

Identifier Type: -

Identifier Source: org_study_id

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