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Effect of Sedation on Diagnostic Injections

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01472835
First received: April 25, 2011
Last updated: May 19, 2014
Last verified: April 2011
Results First Received: March 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Sacroiliac Joint Pain
Sympathetically Maintained Pain
Interventions: Drug: Midazolam
Drug: Fentanyl

  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
Sedation

Pt will receive sedation with their 1st procedure, then a control procedure will be done without sedation

sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".

Sympathetic block: Sympathetic block with bupivacaine

bupivacaine

corticosteroid

Control Patient will not receive sedation during their 1st procedure, but receive sedation during the 2nd procedure

Participant Flow:   Overall Study
    Sedation     Control  
STARTED     37     36  
COMPLETED     35     36  
NOT COMPLETED     2     0  
Lost to Follow-up                 2                 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
Sedation

Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure

sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".

Sympathetic block: Sympathetic block with bupivacaine

bupivacaine

corticosteroid

Control Patient will not receive no sedation during their 1st procedure and sedation during their 2nd procedure
Total Total of all reporting groups

Baseline Measures
    Sedation     Control     Total  
Number of Participants  
[units: participants]
  37     36     73  
Age  
[units: years]
Mean ± Standard Deviation
  49.7  ± 16.1     50.3  ± 13.8     50.0  ± 15.0  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     32     35     67  
>=65 years     5     1     6  
Gender  
[units: participants]
     
Female     20     22     42  
Male     17     14     31  
Region of Enrollment  
[units: participants]
     
United States     37     36     73  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pain Score   [ Time Frame: through 6 hours after injection ]

2.  Secondary:   Pain Score   [ Time Frame: 1-month ]

3.  Secondary:   Procedure-related Pain Score   [ Time Frame: 1 day ]

4.  Secondary:   Oswestry Disability Index   [ Time Frame: 1-month ]

5.  Secondary:   Satisfaction   [ Time Frame: 1 day ]


  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
None


  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: Steven Cohen
Organization: Johns Hopkins
phone: 410-955-1818
e-mail: scohen40@jhmi.edu


Publications:
Publications automatically indexed to this study:

Responsible Party: Steven P. Cohen, Johns Hopkins Medical Institutions
ClinicalTrials.gov Identifier: NCT01472835     History of Changes
Other Study ID Numbers: NA_00045905
Study First Received: April 25, 2011
Results First Received: March 19, 2014
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board