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

January 9, 2012
July 1, 2014
January 2012
March 2013   (final data collection date for primary outcome measure)
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 ]
Duration of an autonomic (sympathetic) nerve block as measured by the time to the return of blocked finger temperature to the immedidate pre-block baseline. Duration of autonomic nerve block: return to baseline finger temperature [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01508832 on ClinicalTrials.gov Archive Site
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Determination of the Duration of Action of a Lidocaine and a Bupivacaine Digital Nerve Block in Human Volunteers
Determination of the Duration of Action of a Lidocaine and a Bupivacaine Digital Nerve Block in Human Volunteers

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Onset and Duration of a Digital Nerve Block.
  • Drug: Lidocaine Digital Nerve Block
    Lidocaine 1% Digital Nerve Block (2 cc
  • Drug: Bupivacaine Digital Block
    Bupivacaine 0.25% Digital Block (2 cc)
  • Active Comparator: Lidocaine
    Lidocaine 1% Digital Nerve Block (2 cc)
    Intervention: Drug: Lidocaine Digital Nerve Block
  • Active Comparator: Bupivacaine
    Bupivacaine 0.25% Digital Block (2 cc)
    Intervention: Drug: Bupivacaine Digital Block
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
12
Not Provided
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01508832
11-06121
Yes
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Ronald Miller, MD University of California, San Francisco
University of California, San Francisco
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP