A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy

NCT ID: NCT02058290

Last Updated: 2014-05-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-02-28

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 hospital 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 or Sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing laparoscopic colectomy with general anesthesia.

Conditions

Bowel Obstruction

Study Design

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

Study Groups

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 in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU is less than one hour.

EXPAREL

EXPAREL (bupivacaine liposome injectable suspension)

Group Type: EXPERIMENTAL

EXPAREL

Intervention Type: DRUG

Patients will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc 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 or Sponsor-approved equivalent

Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU is less than one hour.

Intervention Type: DRUG

EXPAREL

Patients will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc 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

bupivacaine liposome injectable suspension

Eligibility Criteria

Inclusion Criteria

• Male or female, at least 18 years of age.
• Patients scheduled to undergo laparoscopic segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy. (Note: patients who converted from a planned laparoscopic colectomy to an open colectomy were not eligible.)
• 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 or who are unwilling to use acceptable means of contraception for at least 1 month before and 1 month after dosing. Acceptable means of contraception include hormonal contraceptives (e.g., oral, injectable, implantable), effective barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, non-heterosexual lifestyle, or in a strictly monogamous relationship with a partner who has had a vasectomy.
• Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
• Participation in an 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, a patient was ineligible if he or she met the following criteria during surgery:

• Patients who had any concurrent surgical procedure.
• Patients with unplanned multiple segmental resections of large intestine.
• Patients who converted from laparoscopic-assisted colectomy to traditional open colectomy.
• Patients who had unplanned, temporary or permanent colostomies, ileostomies, or the like placed.
• Patients who received intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
• Patients who received Entereg.

• 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

Edward C Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Albany Medical College

Keith Candiotti, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Sergio Bergese, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Eric M Haas, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Jorge Marcet, MD

Role: PRINCIPAL_INVESTIGATOR

Tampa General Hospital

Anjali Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

Washington Hospital Center

Washington D.C., District of Columbia, United States

University of Miami, Dept. Anesthesiology

Miami, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Albany Medical College

Albany, New York, United States

The Ohio State University Medical Center

Columbus, Ohio, United States

Methodist Hospital

Houston, Texas, 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

MA402S23B6A/6B

Identifier Type: -

Identifier Source: org_study_id

NCT01460485

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Identifier Source: nct_alias

NCT01461122

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NCT01461135

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Identifier Source: nct_alias

NCT01509820

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NCT01534988

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NCT01963975

Identifier Type: -

Identifier Source: nct_alias