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

• ClinicalTrials.gov Identifier: NCT02058290
• Recruitment Status: Terminated
• First Posted: February 10, 2014
• Results First Posted: May 14, 2014
• Last Update Posted: May 14, 2014
• Sponsor: Pacira Pharmaceuticals, Inc
• Collaborator: Registrat-Mapi
• Information provided by (Responsible Party): Pacira Pharmaceuticals, Inc

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bowel Obstruction	Drug: IV morphine sulfate or Sponsor-approved equivalent; Drug: EXPAREL	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 122 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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)
• Study Start Date: December 2011
• Actual Primary Completion Date: September 2012
• Actual Study Completion Date: February 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Total Opioid Burden [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ]
   Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.
2. Health Economic Benefits - Total Cost of Hospitalization [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ]
   Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever was sooner.
3. Health Economic Benefits - Length of Stay (LOS) [ Time Frame: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner ]
   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 :

1. Incidence of Opioid-related Adverse Events [ Time Frame: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner. ]
   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. Patient Satisfaction With Pain Treatment After Surgery [ Time Frame: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner. ]
   Responses to question pertaining to patient satisfaction with pain treatment

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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; Medstar Health Research Institute

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pacira Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT02058290
• Obsolete Identifiers: NCT01460485, NCT01461122, NCT01461135, NCT01509820, NCT01534988, NCT01963975
• Other Study ID Numbers: MA402S23B6A/6B
• First Posted: February 10, 2014
• Results First Posted: May 14, 2014
• Last Update Posted: May 14, 2014
• Last Verified: April 2014

Keywords provided by Pacira Pharmaceuticals, Inc:

laparoscopic colectomy

Additional relevant MeSH terms:

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Morphine; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Analgesics, Opioid; Narcotics; Analgesics