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Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25% (Dex Dose)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01690663
First Posted: September 24, 2012
Last Update Posted: May 4, 2017
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 Pennsylvania
Results First Submitted: October 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Post Surgical Pain
Interventions: Drug: Bupivacaine 0.25%
Drug: Dexamethasone
Drug: normal saline

  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
No text entered.

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
Bupivacaine 0.25% Mixed With 1ml Normal Saline

Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)

Bupivacaine 0.25%

normal saline: placebo

Bupivacaine 0.25% With 1mg Dexamethasone (1ml)

Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)

Bupivacaine 0.25%

Dexamethasone

Bupivacaine 0.25% Mixed With 2mg Dexamethasone

Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)

Bupivacaine 0.25%

Dexamethasone

Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml

Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml

Bupivacaine 0.25%

Dexamethasone


Participant Flow:   Overall Study
    Bupivacaine 0.25% Mixed With 1ml Normal Saline   Bupivacaine 0.25% With 1mg Dexamethasone (1ml)   Bupivacaine 0.25% Mixed With 2mg Dexamethasone   Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml
STARTED   23   20   22   24 
COMPLETED   20   17   19   20 
NOT COMPLETED   3   3   3   4 



  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
Bupivacaine 0.25% Mixed With 1ml Normal Saline

Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)

Bupivacaine 0.25%

normal saline: placebo

Bupivacaine 0.25% With 1mg Dexamethasone (1ml)

Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)

Bupivacaine 0.25%

Dexamethasone

Bupivacaine 0.25% Mixed With 2mg Dexamethasone

Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)

Bupivacaine 0.25%

Dexamethasone

Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml

Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml

Bupivacaine 0.25%

Dexamethasone

Total Total of all reporting groups

Baseline Measures
   Bupivacaine 0.25% Mixed With 1ml Normal Saline   Bupivacaine 0.25% With 1mg Dexamethasone (1ml)   Bupivacaine 0.25% Mixed With 2mg Dexamethasone   Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   20   22   24   89 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      23 100.0%      20 100.0%      22 100.0%      24 100.0%      89 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.1  (11.3)   46.2  (11.8)   48.8  (14.1)   53.0  (12.5)   48.4  (12.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      5  21.7%      6  30.0%      6  27.3%      5  20.8%      22  24.7% 
Male      18  78.3%      14  70.0%      16  72.7%      19  79.2%      67  75.3% 
Region of Enrollment 
[Units: Participants]
         
United States   23   20   22   24   89 
BMI 
[Units: Kg/m2]
Mean (Standard Deviation)
 30.4  (6.6)   29.4  (4.0)   28.9  (4.4)   31.0  (6.3)   30.3  (5.7) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Primary Outcome Variable is Post Operative Sensory Block Duration   [ Time Frame: days 1, 2, and day 7 ]

2.  Secondary:   The Secondary Outcome Variable is Post Operative Motor Block Duration   [ Time Frame: days 1, 2, and day 7 ]


  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
First, all information was collected via telephone call during the recovery period at home, during which recall may be inaccurate. Second, we did not control the intravenous dexamethasone use, which could potentially affect the analgesia duration.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jiabin Liu, MD, PhD
Organization: the University of Pennsylvania
phone: 215-573-8208
e-mail: jiabin.liu@uphs.upenn.edu



Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01690663     History of Changes
Other Study ID Numbers: 815628
First Submitted: September 12, 2012
First Posted: September 24, 2012
Results First Submitted: October 21, 2016
Results First Posted: May 4, 2017
Last Update Posted: May 4, 2017