Adult Patients Undergoing Open Colectomy MA402S23B303 (IMPROVE-Open)

Pacira

Status and phase: Completed; Phase 4

Conditions: Bowel Obstruction

Treatments: Drug: IV morphine sulfate; Drug: EXPAREL (bupivacaine liposome injectable suspension)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01507246

MA402S23B303

Details and patient eligibility

About

This study is designed to compare the standard of care against EXPAREL(R) 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 compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing open colectomy with general anesthesia.

Enrollment: 42 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 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 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.
• Patients who undergo any concurrent surgical procedure during the ileostomy reversal surgery

In addition, the patient will be ineligible if he/she meets the following criteria during surgery:

• Patients who have any concurrent surgical procedure.
• Patients with unplanned multiple segmental resections or 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 an other analgesic, local anesthetics, or anti-inflammatory agents.
• Patients who receive Entereg(R).

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

IV morphine sulfate

Active Comparator group

Description:

Standard of Care (SOC), dosage variable, administered intravenously via PCA pump postsurgically, as need.

Treatment:

Drug: IV morphine sulfate

EXPAREL (bupivacaine liposome injectable suspension)

Experimental group

Description:

EXPAREL(R), dosage 266 mg, diluted with 0.9% saline to a total volume of 40 cc.

Treatment:

Drug: EXPAREL (bupivacaine liposome injectable suspension)