Adult Patients Undergoing Open Colectomy MA402S23B303

NCT ID: NCT01507246

Last Updated: 2013-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-08-31

Brief Summary

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.

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 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.

Conditions

Bowel Obstruction

Study Design

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

Study Groups

IV morphine sulfate

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

Group Type: ACTIVE_COMPARATOR

IV morphine sulfate

Intervention Type: DRUG

Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour.

EXPAREL (bupivacaine liposome injectable suspension)

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

Group Type: EXPERIMENTAL

EXPAREL (bupivacaine liposome injectable suspension)

Intervention Type: DRUG

Patients 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, 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.

Interventions

IV morphine sulfate

Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour.

Intervention Type: DRUG

EXPAREL (bupivacaine liposome injectable suspension)

Patients 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, 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.

Intervention Type: DRUG

Other Intervention Names

morphine sulfate (or Sponsor-approved equivalent); bupivacaine free base

Eligibility Criteria

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).

• 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

Stephen Cohen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Atlanta Colon and Rectal Surgery

Locations

Atlanta Colon and Rectal Surgery

Riverdale, Georgia, United States

Countries

United States

References

Cohen SM, Vogel JD, Marcet JE, Candiotti KA. Liposome bupivacaine for improvement in economic outcomes and opioid burden in GI surgery: IMPROVE Study pooled analysis. J Pain Res. 2014 Jun 24;7:359-66. doi: 10.2147/JPR.S63764. eCollection 2014.

Reference Type: DERIVED

PMID: 25018650 (View on PubMed)

Other Identifiers

MA402S23B303

Identifier Type: -

Identifier Source: org_study_id