A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301 (IMPROVE-Open)

Pacira

Status and phase

Terminated

Phase 4

Conditions

Bowel Obstruction

Treatments

Drug: morphine sulfate

Drug: bupivacaine liposome extended-release injectable suspension

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01507220

MA402S23B301

Details and patient eligibility

About

This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome extended-release 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 extended-release injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate for postsurgical analgesia in adult patients undergoing open colectomy with general anesthesia.

Enrollment

2 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 open segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy.
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.
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 a 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, the patient will be ineligible if he or she meets the following criteria during surgery:

Patients with unplanned multiple segmental resections of large intestine.
Patients who have unplanned, temporary or permanent colostomies, ileostomies, or the like placed.
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).
Patients who undergo any concurrent surgical procedure during the ileostomy reversal surgery.