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Dexamethasone and Lower Extremity Block Duration

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.
 
ClinicalTrials.gov Identifier: NCT01756586
Recruitment Status : Terminated (no logistical support to carry out the study fairly)
First Posted : December 27, 2012
Results First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE December 20, 2012
First Posted Date  ICMJE December 27, 2012
Results First Submitted Date  ICMJE June 16, 2016
Results First Posted Date  ICMJE June 27, 2017
Last Update Posted Date June 27, 2017
Study Start Date  ICMJE February 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
Increase in the Duration of Block [ Time Frame: 3 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2012)
Increase in the Duration of Block [ Time Frame: one year ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexamethasone and Lower Extremity Block Duration
Official Title  ICMJE Not Provided
Brief Summary Dexamethasone has shown to prolong upper extremity blocks. No one ha studied its effect on lower extremity blocks. The study would evaluate that point.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Analgesia Duration
Intervention  ICMJE
  • Drug: Dexamethasone
  • Drug: Bupivacaine
    Control
Study Arms  ICMJE
  • Active Comparator: Control
    Plain bupivacaine
    Intervention: Drug: Bupivacaine
  • Experimental: Experimental
    Bupivacaine with Dexamethasone
    Interventions:
    • Drug: Dexamethasone
    • Drug: Bupivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 24, 2017)
4
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2012)
40
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18-75
  2. foot surgery
  3. no contraindication to regional anesthesia

Exclusion Criteria:

  1. opioid dependent
  2. chronic pain condition
  3. peripheral neuropathy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01756586
Other Study ID Numbers  ICMJE IRB12-2198
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Chicago
Verification Date May 2017

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