TAP-patients With Robotic Assisted Lap Prostatectomy (TAP)

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. Identifier: NCT01582477
Recruitment Status : Completed
First Posted : April 20, 2012
Results First Posted : June 10, 2013
Last Update Posted : June 10, 2013
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Postsurgical Pain
Interventions: Drug: EXPAREL 20 mL
Drug: EXPAREL 40 mL

  Participant Flow

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
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Reporting Groups
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 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   6   9   15 
>=65 years   6   3   9 
[Units: Years]
Mean (Standard Deviation)
 60.7  (7.24)   61.7  (7.01)   61.2  (6.99) 
[Units: Participants]
Female   0   0   0 
Male   12   12   24 
Region of Enrollment 
[Units: Participants]
United States   12   12   24 

  Outcome Measures

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

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

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

Responsible Party: Pacira Pharmaceuticals, Inc Identifier: NCT01582477     History of Changes
Other Study ID Numbers: MA402S23B701
First Submitted: April 19, 2012
First Posted: April 20, 2012
Results First Submitted: February 26, 2013
Results First Posted: June 10, 2013
Last Update Posted: June 10, 2013