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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01508832
First received: January 9, 2012
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Onset and Duration of a Digital Nerve Block.
Drug: Lidocaine Digital Nerve Block
Drug: Bupivacaine Digital Block
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Determination of the Duration of Action of a Lidocaine and a Bupivacaine Digital Nerve Block in Human Volunteers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The Change in the Average Finger Temperature From Baseline to Post-intervention. [ Time Frame: 30 minutes prior and 240 minutes post intervention. ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: January 2012
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01508832

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 Miller, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01508832     History of Changes
Other Study ID Numbers: 11-06121
Study First Received: January 9, 2012
Results First Received: May 23, 2013
Last Updated: July 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bupivacaine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014