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

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ClinicalTrials.gov Identifier: NCT01508832
Recruitment Status : Completed
First Posted : January 12, 2012
Results First Posted : August 19, 2013
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Onset and Duration of a Digital Nerve Block Drug: Lidocaine Digital Nerve Block Drug: Bupivacaine Digital Block Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Determination of the Duration of Action of a Lidocaine and a Bupivacaine Digital Nerve Block in Human Volunteers
Actual Study Start Date : January 2012
Actual Primary Completion Date : March 2013

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Arms and Interventions
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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)


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT01508832


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Ronald Miller, MD University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01508832    
Other Study ID Numbers: 11-06121
First Posted: January 12, 2012    Key Record Dates
Results First Posted: August 19, 2013
Last Update Posted: January 30, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Lidocaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action