TAP-patients With Robotic Assisted Lap Prostatectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01582477
First received: April 19, 2012
Last updated: May 5, 2013
Last verified: May 2013
Results First Received: February 26, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Postsurgical Pain
Analgesia
Prostatectomy
Interventions: Drug: EXPAREL 20 mL
Drug: EXPAREL 40 mL

  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
EXPAREL 20 mL Group receiving EXPAREL 20 mL
EXPAREL 40 mL Group receiving EXPAREL 40 mL

Participant Flow:   Overall Study
    EXPAREL 20 mL     EXPAREL 40 mL  
STARTED     12     12  
COMPLETED     12     12  
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.
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Reporting Groups
  Description
EXPAREL 20 mL Group receiving EXPAREL 20 mL
EXPAREL 40 mL Group receiving EXPAREL 40 mL
Total Total of all reporting groups

Baseline Measures
    EXPAREL 20 mL     EXPAREL 40 mL     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     9     15  
>=65 years     6     3     9  
Age  
[units: years]
Mean ± Standard Deviation
  60.7  ± 7.24     61.7  ± 7.01     61.2  ± 6.99  
Gender  
[units: participants]
     
Female     0     0     0  
Male     12     12     24  
Region of Enrollment  
[units: participants]
     
United States     12     12     24  



  Outcome Measures
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1.  Primary:   The Duration of Abdominal Analgesia From Infiltration Into the TAP   [ Time Frame: First postsurgical administration of an opioid ]

2.  Secondary:   Subject Reported Postsurgical Pain   [ Time Frame: 1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP ]

3.  Secondary:   Physician/Healthcare Professional Assessed Postsurgical Pain   [ Time Frame: 1, 2, 6, 12, 24 hours after TAP ]

4.  Secondary:   Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.   [ Time Frame: 48, 72, 96 hours, and 10 days ]

5.  Secondary:   Incidence of Prespecified Opioid-related Adverse Events   [ Time Frame: Until hospital discharge order was written, anticipated at 24 hours. ]

6.  Secondary:   Overall Rating of Subject Satisfaction With Postsurgical Pain Control   [ Time Frame: 24 hours, 72 hours, and day 10 ]


  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: Andrew Sternlicht, MD
Organization: St. Elizabeth's Medical Center
phone: 617-789-2777
e-mail: andrew.sternlicht@steward.org


No publications provided


Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01582477     History of Changes
Other Study ID Numbers: MA402S23B701
Study First Received: April 19, 2012
Results First Received: February 26, 2013
Last Updated: May 5, 2013
Health Authority: United States: Food and Drug Administration