Determination of the Duration of Action of a Lidocaine and a Bupivacaine Digital Nerve Block in Human Volunteers

January 14, 2020 updated by: University of California, San Francisco
The duration of the autonomic (sympathetic) block will last longer than the sensory block. The duration of the increased perfusion index will last longer than either the sympathetic or sensory block.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Masimo SpHb™ (SpHb) is a device used to monitor the blood hemoglobin level via a sticky sensor connected to a finger. Our results from 2 recent studies undertaken with this device concluded: 1) that it is not always accurate when the finger is cold such as during surgical blood loss, and 2) a local nerve block to the finger improved the finger temperature and the accuracy of the device.

Our purpose is to investigate the duration of effect of two local nerve blocking drugs (lidocaine and bupivacaine - both FDA approved drugs in routine use) in a finger on each hand. Having a better understanding of how long the nerve block lasts could help determine when an additional block might be necessary to maintain the accuracy of the device during surgical blood loss.

We previously listed the primary outcome for this study as the time until return to baseline finger temperature. However, in blinded looks at the data it became clear that defining time until return to baseline from the serial temperature measurements in an objective fashion would be extremely difficult and potentially controversial. We have modified the primary outcome to be the change in the average temperature from baseline to post-intervention.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-smokers

Exclusion Criteria:

  • History of allergic response to local anesthetics
  • BMI >25
  • Pregnant of nursing
  • Current smokers or past smokers of > 1 pack year history
  • Neurological deficit and/or injury in the upper extremities
  • Current respiratory infection
  • Per investigator judgement, would not be suitable for study

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lidocaine
Lidocaine 1% Digital Nerve Block (2 cc)
Drug: Lidocaine Digital Nerve Block
Lidocaine 1% Digital Nerve Block (2 cc
Active Comparator: Bupivacaine
Bupivacaine 0.25% Digital Block (2 cc)
Drug: Bupivacaine Digital Block
Bupivacaine 0.25% Digital Block (2 cc)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Change in the Average Finger Temperature From Baseline to Post-intervention.
Time Frame: 30 minutes prior and 240 minutes post intervention.
30 minutes prior and 240 minutes post intervention.

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 Miller, MD, 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 (Actual)

January 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 11, 2012

First Posted (Estimate)

January 12, 2012

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-06121

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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