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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:
ClinicalTrials.gov Identifier:
NCT01508832
First Posted: January 12, 2012
Last Update Posted: July 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
Results First Submitted: May 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, 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
No text entered.

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 
Overall Participants Analyzed 
[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



Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01508832     History of Changes
Other Study ID Numbers: 11-06121
First Submitted: January 9, 2012
First Posted: January 12, 2012
Results First Submitted: May 23, 2013
Results First Posted: August 19, 2013
Last Update Posted: July 15, 2014