A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501 (IMPROVE-IR)

This study has been completed.
Sponsor:
Collaborator:
Registrat-Mapi
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01509638
First received: October 24, 2011
Last updated: January 19, 2014
Last verified: January 2014
Results First Received: November 30, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Retraction of Colostomy
Interventions: Drug: Group 1 Standard of Care
Drug: Group 2 EXPAREL

  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
23 patients in Group 1 and 25 patients in Group 2 were enrolled. 22 patients from Group 1 and 23 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)

Reporting Groups
  Description
Group 1 Standard of Care

IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump

Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.

Group 2 EXPAREL

bupivacaine liposome injectable suspension.

Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.


Participant Flow:   Overall Study
    Group 1 Standard of Care     Group 2 EXPAREL  
STARTED     23     26  
COMPLETED     20     24  
NOT COMPLETED     3     2  



  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.
23 patients in Group 1 and 25 patients in Group 2 were enrolled. 22 patients from Group 1 and 23 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).

Reporting Groups
  Description
Group 1 Standard of Care

IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump

Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.

Group 2 EXPAREL

bupivacaine liposome injectable suspension.

Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.

Total Total of all reporting groups

Baseline Measures
    Group 1 Standard of Care     Group 2 EXPAREL     Total  
Number of Participants  
[units: participants]
  22     25     47  
Age  
[units: years]
Mean ± Standard Deviation
  47.1  ± 17.87     48.2  ± 14.53     47.7  ± 16.01  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     18     24     42  
>=65 years     4     1     5  
Gender  
[units: participants]
     
Female     8     11     19  
Male     14     14     28  
Region of Enrollment  
[units: participants]
     
United States     22     25     47  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Opioid Burden   [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner ]

2.  Primary:   Health Economic Benefits   [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ]

3.  Primary:   Health Economic Benefit   [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ]

4.  Secondary:   Incidence of Opioid-related Adverse Events   [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ]

5.  Secondary:   Patient Satisfaction With Postsurgical Analgesia   [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ]

6.  Secondary:   Patient Discharged From Hospital for at Least 3 Days   [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ]

7.  Secondary:   Patient Made Unplanned Visit(s) With Any Healthcare Providers   [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ]

8.  Secondary:   Contact or Attempted to Contact Surgeon/Doctor to Discuss Recovery After Surgery   [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ]

9.  Secondary:   Experienced Health Problems or Changes in Health Since Hospital Discharge   [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ]

10.  Secondary:   Time to First Opioid Administration   [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ]


  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: Marylise Boutrous, MD
Organization: Cleveland Clinic Florida
phone: 954-659-5000
e-mail: canedoj@ccf.org


No publications provided


Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01509638     History of Changes
Other Study ID Numbers: MA402S23B501
Study First Received: October 24, 2011
Results First Received: November 30, 2013
Last Updated: January 19, 2014
Health Authority: United States: Food and Drug Administration