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
  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 hospital 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: Parallel 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(R): 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 - 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.


Secondary Outcome Measures:
  • 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


Enrollment: 122
Study Start Date: December 2011
Study Completion Date: February 2013
Primary Completion Date: September 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 a floor if the stay in the PACU is less than one hour.
Experimental: EXPAREL
EXPAREL (bupivacaine liposome injectable suspension)
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

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, 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.
  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: NCT02058290

Locations
United States, District of Columbia
Washington Hospital Center
Washington DC, District of Columbia, United States, 20010
United States, Florida
University of Miami, Dept. Anesthesiology
Miami, Florida, United States, 33136
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, New York
Albany Medical College
Albany, New York, United States, 12208
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Texas
Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Registrat-Mapi
Investigators
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
  More Information

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

Keywords provided by Pacira Pharmaceuticals, Inc:
laparoscopic colectomy

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

ClinicalTrials.gov processed this record on October 29, 2014