A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy

NCT02058290 | Terminated Phase 4 Results DMC

• 1 other identifier: MA402S23B6A/6B
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Bowel Obstruction

Keywords

laparoscopic colectomy

Outcome Measures

Primary Outcomes (3)

• Total Opioid Burden

  Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.

  Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.

• Health Economic Benefits - Total Cost of Hospitalization

  Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever was sooner.

  Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.

• Health Economic Benefits - Length of Stay (LOS)

  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.

  Wound closure at time hospital discharge order is written or Day 30, whichever is sooner

Secondary Outcomes (2)

• Incidence of Opioid-related Adverse Events

  Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.

• Patient Satisfaction With Pain Treatment After Surgery

  Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.

Study Arms (2)

IV Morphine Sulfate or Sponsor-approved Equivalent

ACTIVE COMPARATOR

Standard of Care (SOC)

Drug: IV morphine sulfate or Sponsor-approved equivalent

EXPAREL

EXPERIMENTAL

EXPAREL (bupivacaine liposome injectable suspension)

Drug: EXPAREL

Interventions

IV morphine sulfate or Sponsor-approved equivalent DRUG

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.

IV Morphine Sulfate or Sponsor-approved Equivalent

EXPAREL DRUG

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.

Also known as: bupivacaine liposome injectable suspension

EXPAREL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead
• Registrat-Mapi: collaborator

Study Sites (6)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Miami, Dept. Anesthesiology

Miami, Florida, 33136, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Cohen SM, Vogel JD, Marcet JE, Candiotti KA. Liposome bupivacaine for improvement in economic outcomes and opioid burden in GI surgery: IMPROVE Study pooled analysis. J Pain Res. 2014 Jun 24;7:359-66. doi: 10.2147/JPR.S63764. eCollection 2014.

  PMID: 25018650 DERIVED

MeSH Terms

Conditions

Intestinal Obstruction

Interventions

Morphine

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Erol Onel, MD
• Organization: Pacira Pharmaceuticals, Inc.

erol.onel@pacira.com

858-625-2424

Study Officials

• 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 Research Institute

  PRINCIPAL INVESTIGATOR

• Jorge Marcet, MD

  Tampa General Hospital

  PRINCIPAL INVESTIGATOR

• Anjali Kumar, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 10, 2014
• Study Start: December 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: February 1, 2013
• Last Updated: May 14, 2014
• Results First Posted: May 14, 2014

Record last verified: 2014-04

Locations

US (6)