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

This study has been completed.
Sponsor:
Collaborator:
Registrat-Mapi
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01509820
First received: October 24, 2011
Last updated: May 15, 2013
Last verified: May 2013

October 24, 2011
May 15, 2013
March 2012
November 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 [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: No ]
    1. Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.
    2. Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.
  • Total opioid burden [ Time Frame: Wound closure to time hospital discharge order 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 [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner. ] [ Designated as safety issue: No ]
    1. Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.
    2. Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.
Complete list of historical versions of study NCT01509820 on ClinicalTrials.gov Archive Site
Incidence of opioid-related adverse events and patient satisfaction with postsurgical analgesia. [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
  1. 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.
  2. Responses to one question pertaining to patient satisfaction with postsurgical analgesia and four questions pertaining to postsurgical recovery following hospital discharge.
Incidence of opioid related adverse events and patient satisfaction with postsurgical analgesia. [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
  1. Incidence of opioid-related adverse events definded as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.
  2. 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 (IMPROVE-Lap Colectomy)
A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation of Bupivacaine, EXPAREL: 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 hospitalization 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: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Bowel Obstruction
  • Drug: IV morphine sulfate or Sponsor-approved equivalent
    Patients enrolled 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 the floor if the stay in the PACU is less than one hour.
  • Drug: EXPAREL

    Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc 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, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the stie's standard of care.

    All patient 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.
 
Completed
60
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, 18 years of age and older.
  • Patients scheduled to undergo laparoscopic-assisted colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy. (Note: patients who convert from a planned laparoscopic colectomy to an open colectomy are not eligible)
  • Ability to provide informed consent, adhere to study visit schedule, and complete all 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.
  • Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
  • Patients who have participated in an EXPAREL study within the last 30 days.
  • Patients who have received an 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, the patient will be ineligible if he/she meets the following criteria during surgery:

  • Patients who have any concurrent procedure.
  • Patients with unplanned multiple segmental resections of large intestine.
  • Patients who convert from laparoscopic-assisted colectomy to traditional open colectomy.
  • Patients who have unplanned, temporary, or permanent colostomies, ileostomies, or the like placed.
  • Patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
  • Patients who receive Entereg(R).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01509820
MA402S23B606
No
Pacira Pharmaceuticals, Inc
Pacira Pharmaceuticals, Inc
Registrat-Mapi
Principal Investigator: Eric M Haas, M.D. The Methodist Hospital System
Pacira Pharmaceuticals, Inc
May 2013

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