A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy (IMPROVE-Lap)

This study has been terminated.
(Slower than expected enrollment)
Sponsor:
Collaborator:
Registrat-Mapi
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT02058290
First received: February 6, 2014
Last updated: April 15, 2014
Last verified: April 2014
Results First Received: February 19, 2014  
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: Bowel Obstruction
Interventions: Drug: IV morphine sulfate or Sponsor-approved equivalent
Drug: 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
No text entered.

Reporting Groups
  Description
IV Morphine Sulfate or Sponsor-approved Equivalent

Standard of Care (SOC)

IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour.

EXPAREL

EXPAREL (bupivacaine liposome injectable suspension)

EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.

All patients were offered rescue analgesia, as needed.


Participant Flow:   Overall Study
    IV Morphine Sulfate or Sponsor-approved Equivalent     EXPAREL  
STARTED     77     45  
COMPLETED     66     36  
NOT COMPLETED     11     9  
Protocol Violation                 2                 1  
Physician Decision                 1                 0  
Didn't meet intraoperative criteria                 8                 7  
Withdrawal by Subject                 0                 1  



  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.
122 subjects were enrolled. Of these, 105 subjects received study drug: 67 subjects received IV morphine sulfate or sponsor-approved equivalent and 38 subjects received EXPAREL.

Reporting Groups
  Description
IV Morphine Sulfate or Sponsor-approved Equivalent

Standard of Care (SOC)

IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour.

EXPAREL

EXPAREL (bupivacaine liposome injectable suspension)

EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.

All patients were offered rescue analgesia, as needed.

Total Total of all reporting groups

Baseline Measures
    IV Morphine Sulfate or Sponsor-approved Equivalent     EXPAREL     Total  
Number of Participants  
[units: participants]
  67     38     105  
Age  
[units: years]
Mean ± Standard Deviation
  58.6  ± 14.35     57.8  ± 11.86     58.3  ± 13.45  
Gender  
[units: participants]
     
Female     35     21     56  
Male     32     17     49  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic or Latino     7     4     11  
Not Hispanic or Latino     60     34     94  
American Society of Anesthesiologist (ASA) Classification  
[units: participants]
     
Normal [1]     1     0     1  
Mild Systemic Disease [2]     32     25     57  
Severe Systemic Disease [3]     32     13     45  
Severe Systemic Disease Threat to Life [4]     2     0     2  
Patient's Pain Level 24 Hours Prior to Surgery [1]
[units: units on a scale]
Mean ± Standard Deviation
  1.9  ± 2.14     1.3  ± 0.86     1.7  ± 1.81  
[1] Patient’s Pain Level 24 Hours Prior to Surgery was measured on a scale from 0 to 10 where 0 = no pain and 10 = worst possible pain.



  Outcome Measures
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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 - Total Cost of Hospitalization   [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ]

3.  Primary:   Health Economic Benefits - Length of Stay (LOS)   [ Time Frame: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner ]

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

5.  Secondary:   Patient Satisfaction With Pain Treatment After Surgery   [ Time Frame: Wound closure at 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: Erol Onel, MD
Organization: Pacira Pharmaceuticals, Inc.
phone: 858-625-2424
e-mail: erol.onel@pacira.com


No publications provided


Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02058290     History of Changes
Obsolete Identifiers: NCT01460485, NCT01461122, NCT01461135, NCT01509820, NCT01534988, NCT01963975
Other Study ID Numbers: MA402S23B6A/6B
Study First Received: February 6, 2014
Results First Received: February 19, 2014
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration