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

February 6, 2014
April 15, 2014
December 2011
September 2012   (final data collection date for primary outcome measure)
  • Total Opioid Burden [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
    Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.
  • Health Economic Benefits - Total Cost of Hospitalization [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: No ]
    Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever was sooner.
  • Health Economic Benefits - Length of Stay (LOS) [ Time Frame: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner ] [ Designated as safety issue: No ]
    Length of stay, recorded in days, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.
Same as current
Complete list of historical versions of study NCT02058290 on ClinicalTrials.gov Archive Site
  • Incidence of Opioid-related Adverse Events [ Time Frame: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
    Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.
  • Patient Satisfaction With Pain Treatment After Surgery [ Time Frame: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: No ]
    Responses to question pertaining to patient satisfaction with pain treatment
  • Incidence of opioid-related adverse events [ Time Frame: Wound closure at time hospital dicharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
    Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.
  • Patient satisfaction with postsurgical analgesia [ Time Frame: Wound closure at time hospital dicharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: No ]
    Responses to one question pertaining to patient satisfaction with postsurgical analgesia and four questions pertaining to postsurgical recovery following hospital discharge.
Not Provided
Not Provided
 
A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy
A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation of Bupivacaine, EXPAREL(R): A Phase 4 Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy (IMPROVE-Lap Colectomy)

This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospital costs.

This is a Phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL (bupivacaine liposome injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or Sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing laparoscopic colectomy with general anesthesia.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Bowel Obstruction
  • Drug: IV morphine sulfate or Sponsor-approved equivalent
    Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump will be 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 is less than one hour.
  • Drug: EXPAREL

    Patients will receive 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 will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.

    All patients will be offered rescue analgesia, as needed.

    Other Name: bupivacaine liposome injectable suspension
  • Active Comparator: IV Morphine Sulfate or Sponsor-approved Equivalent
    Standard of Care (SOC)
    Intervention: Drug: IV morphine sulfate or Sponsor-approved equivalent
  • Experimental: EXPAREL
    EXPAREL (bupivacaine liposome injectable suspension)
    Intervention: Drug: EXPAREL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
122
February 2013
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, at least 18 years of age.
  • Patients scheduled to undergo laparoscopic segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy. (Note: patients who converted from a planned laparoscopic colectomy to an open colectomy were not eligible.)
  • Ability to provide informed consent, adhere to study visit schedule, and complete all study assessments.

Exclusion Criteria:

  • Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol.
  • Patients who abuse alcohol or other drug substance.
  • Patients with severe hepatic impairment.
  • Patients currently pregnant or who may become pregnant during the course of the study or who are unwilling to use acceptable means of contraception for at least 1 month before and 1 month after dosing. Acceptable means of contraception include hormonal contraceptives (e.g., oral, injectable, implantable), effective barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, non-heterosexual lifestyle, or in a strictly monogamous relationship with a partner who has had a vasectomy.
  • Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
  • Participation in an EXPAREL study within the last 30 days.
  • Patients who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study.

In addition, a patient was ineligible if he or she met the following criteria during surgery:

  • Patients who had any concurrent surgical procedure.
  • Patients with unplanned multiple segmental resections of large intestine.
  • Patients who converted from laparoscopic-assisted colectomy to traditional open colectomy.
  • Patients who had unplanned, temporary or permanent colostomies, ileostomies, or the like placed.
  • Patients who received intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
  • Patients who received Entereg.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02058290
MA402S23B6A/6B
Yes
Pacira Pharmaceuticals, Inc
Pacira Pharmaceuticals, Inc
Registrat-Mapi
Principal Investigator: Edward C Lee, MD Albany Medical College
Principal Investigator: Keith Candiotti, MD University of Miami
Principal Investigator: Sergio Bergese, MD Ohio State University
Principal Investigator: Eric M Haas, MD The Methodist Hospital System
Principal Investigator: Jorge Marcet, MD Tampa General Hospital
Principal Investigator: Anjali Kumar, MD Washington Hospital Center
Pacira Pharmaceuticals, Inc
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP