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

This study is currently recruiting participants.
Verified November 2012 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01508832
First received: January 9, 2012
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  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 With 2 Local Anesthetics.
 Drug: Lidocaine
Drug: Bupivacaine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Duration of an autonomic (sympathetic) nerve block as measured by the time to the return of blocked finger temperature to the immediate pre-block baseline. Duration of autonomic nerve block: return to baseline finger temperature [ Time Frame: Time to return of blocked finger temperature to the immediate pre-block baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: January 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lidocaine Digital Nerve Block
Lidocaine Digital Nerve Block
 Drug: Lidocaine
Lidocaine 1%, 2cc Digital Nerve Block x 1 dose
Active Comparator: Bupivacaine Digital Nerve Block
Bupivacaine Digital Nerve Block
 Drug: Bupivacaine
Bupivacaine 0.25%, 2cc x 1

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508832

Contacts
Contact: Ronald D Miller, MD 415 476-9034 millerr@anesthesia.ucsf.edu
Contact: Theresa A Ward, BSN, RN 415 514-0685 wardt@anesthesia.ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Ronald D Miller, MD            
Sub-Investigator: Theresa A Ward, BSN, RN            
Sub-Investigator: Neal H Cohen, MD, MPH, MS            
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
Last Updated: November 16, 2012
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

ClinicalTrials.gov processed this record on May 16, 2013