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

This study has been completed.
Sponsor:
Collaborator:
Registrat-Mapi
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01461135
First received: October 24, 2011
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Bowel Obstruction
Drug: IV Morphine Sulfate or Sponsor-approved Equivalent
Drug: EXPAREL
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:
  • 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 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.


Secondary Outcome Measures:
  • Incidence of opioid-related adverse events and patient satisfaction with postsurgical analgesia [ Time Frame: Wound closure to time hospital discharge order wrtten 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.


Estimated Enrollment: 60
Study Start Date: December 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IV Morphine Sulfate or Sponsor-approved Equivalent
Standard of Care (SOC)
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 the floor if the stay in the PACU is less than one hour.
Experimental: EXPAREL
EXPAREL (bupivacaine liposome injectable suspension)
Drug: EXPAREL

Patients in this group 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 surgical 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461135

Locations
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Registrat-Mapi
Investigators
Principal Investigator: Edward C Lee, M.D. Albany Medical College
  More Information

No publications provided

Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01461135     History of Changes
Other Study ID Numbers: MA402S23B601
Study First Received: October 24, 2011
Last Updated: May 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:
colectomy
laparoscopic colectomy

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Bupivacaine
Morphine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics

ClinicalTrials.gov processed this record on July 31, 2014