Clinical trial NCT02058290: A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bowel Obstruction
Keywords: laparoscopic colectomy
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: Registrat-Mapi
First posted: 2014-02-10
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 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.

Primary outcomes:
measure: Total Opioid Burden
timeFrame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
measure: Health Economic Benefits - Total Cost of Hospitalization
timeFrame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
measure: Health Economic Benefits - Length of Stay (LOS)
timeFrame: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner
Secondary outcomes:
measure: Incidence of Opioid-related Adverse Events
timeFrame: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.
measure: Patient Satisfaction With Pain Treatment After Surgery
timeFrame: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.
Other outcomes:
Locations:
city: Washington DC
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Miami
country: United States
facility: University of Miami, Dept. Anesthesiology
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
Study officials:
affiliation: Albany Medical College
name: Edward C Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Keith Candiotti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Sergio Bergese, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Methodist Hospital Research Institute
name: Eric M Haas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampa General Hospital
name: Jorge Marcet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medstar Health Research Institute
name: Anjali Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.