A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy

Bowel Obstruction Clinical Trial

— IMPROVE-Lap  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02058290
• Other study ID #: MA402S23B6A/6B
• Status: Terminated
• Phase: Phase 4
• First received: February 6, 2014
• Last updated: April 15, 2014
• Start date: December 2011
• Est. completion date: February 2013

Study information

• Verified date: April 2014
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01460485
• NCT01461122
• NCT01461135
• NCT01509820
• NCT01534988
• NCT01963975

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 122
• Est. completion date: February 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Bowel Obstruction
• Intestinal Obstruction

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Methodist Hospital	Houston	Texas
United States	University of Miami, Dept. Anesthesiology	Miami	Florida
United States	Tampa General Hospital	Tampa	Florida
United States	Washington Hospital Center	Washington DC	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc	Registrat-Mapi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Primary	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.	No
Primary	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	No
Secondary	Incidence of Opioid-related Adverse Events	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.	Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.	Yes
Secondary	Patient Satisfaction With Pain Treatment After Surgery	Responses to question pertaining to patient satisfaction with pain treatment	Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.	No