A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504

NCT ID: NCT01509807

Last Updated: 2014-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-10-31

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 hospitalization 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 for postsurgical analgesia in adult patients undergoing ileostomy reversal with general anesthesia.

Conditions

Retraction of Colostomy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Group 1

IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)

Group Type: ACTIVE_COMPARATOR

IV morphine sulfate or Sponsor-approved equivalent

Intervention Type: DRUG

Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.

Group 2

EXPAREL (bupivacaine liposome injectable suspension)

Group Type: EXPERIMENTAL

EXPAREL

Intervention Type: DRUG

Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and 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, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.

Interventions

IV morphine sulfate or Sponsor-approved equivalent

Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.

Intervention Type: DRUG

EXPAREL

Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and 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, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.

Intervention Type: DRUG

Other Intervention Names

bupivacaine liposome injectable suspension

Eligibility Criteria

Inclusion Criteria

• Male or female, 18 years of age and older
• Patients scheduled to undergo ileostomy reversal
• Ability to provide informed consent, adhere to study visit schedule, and complete all 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 lest one month before and one month after dosing.
• Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
• Patients who have participated in an EXPAREL study within the last 30 days.
• Patients who have received an 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, the patient will be ineligible if he/she meets the following criteria during surgery:

• Patients who have any concurrent surgical procedure.
• Patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
• Patients who receive Entereg(R).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Registrat-Mapi

OTHER

Sponsor Role: collaborator

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge Marcet, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida, Tampa, FL

Valentine Nfonsam, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona, Tucson, AZ

Sergio Larach, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Hospital, Orlando, FL.

Locations

University of Arizona College of Medicine

Tucson, Arizona, United States

Florida Hospital d/b/a Colon & Rectal Surgery Center

Orlando, Florida, United States

University of South Florida

Tampa, Florida, United States

Countries

United States

Other Identifiers

MA402S23B504

Identifier Type: -

Identifier Source: org_study_id