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
Results First Received: May 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Outcomes Assessor)
Condition: Onset and Duration of a Digital Nerve Block.
Interventions: Drug: Lidocaine Digital Nerve Block
Drug: Bupivacaine Digital Block

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Volunteers recruited through local media source. Protocol consisted of a single study day in anesthesia research study space at the University of California San Francisco Parnassus campus.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger Lidocaine 1% digital nerve block (2cc), right finger; Bupivacaine 0.25% digital nerve block (2cc), left finger.
Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger Lidocaine 1% digital nerve block (2cc), left finger; Bupivacaine 0.25% digital nerve block (2cc), right finger.

Participant Flow:   Overall Study
    Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger     Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger  
STARTED     6     6  
COMPLETED     6     6  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger Lidocaine 1% Digital Nerve Block (2 cc) , right finger. Bupivacaine 0.25% Digital Nerve Block (2 cc), left finger
Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger Lidocaine 1% Digital Block (2cc), left finger; Bupivacaine 0.25% Digital Block (2 cc), right finger.
Total Total of all reporting groups

Baseline Measures
    Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger     Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger     Total  
Number of Participants  
[units: participants]
  6     6     12  
Age  
[units: years]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     6     12  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     3     3     6  
Male     3     3     6  
Region of Enrollment  
[units: participants]
     
United States     6     6     12  



  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ronald D Miller, MD
Organization: University of California San Francisco
phone: 415 476-9034
e-mail: millerr@anesthesia.ucsf.edu


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