A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504 (IMPROVE-IR)

Pacira

Status and phase

Completed

Phase 4

Conditions

Retraction of Colostomy

Treatments

Drug: IV morphine sulfate or Sponsor-approved equivalent

Drug: EXPAREL

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01509807

MA402S23B504

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).