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Dexamethasone and Lower Extremity Block Duration

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Analgesia Duration
Interventions Drug: Dexamethasone
Drug: Bupivacaine
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Experimental
Hide Arm/Group Description

Plain bupivacaine

Bupivacaine: Control

Bupivacaine with Dexamethasone

Dexamethasone

Bupivacaine: Control

Period Title: Overall Study
Started 2 2
Completed 0 0
Not Completed 2 2
Arm/Group Title Control Experimental Total
Hide Arm/Group Description

Plain bupivacaine

Bupivacaine: Control

Bupivacaine with Dexamethasone

Dexamethasone

Bupivacaine: Control

Total of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
2
 100.0%
4
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Female
1
  50.0%
1
  50.0%
2
  50.0%
Male
1
  50.0%
1
  50.0%
2
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 4 participants
2 2 4
1.Primary Outcome
Title Increase in the Duration of Block
Hide Description [Not Specified]
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Did not have resources to follow up with the subjects after the surgery. The study was terminated early.
Arm/Group Title Control Experimental
Hide Arm/Group Description:

Plain bupivacaine

Bupivacaine: Control

Bupivacaine with Dexamethasone

Dexamethasone

Bupivacaine: Control

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Experimental
Hide Arm/Group Description

Plain bupivacaine

Bupivacaine: Control

Bupivacaine with Dexamethasone

Dexamethasone

Bupivacaine: Control

All-Cause Mortality
Control Experimental
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Control Experimental
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Experimental
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: TARIQ MALIK
Organization: University of Chicago
Phone: 773-834 3643
EMail: tmalik@dacc.uchicago.edu
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01756586    
Other Study ID Numbers: IRB12-2198
First Submitted: December 20, 2012
First Posted: December 27, 2012
Results First Submitted: June 16, 2016
Results First Posted: June 27, 2017
Last Update Posted: June 27, 2017