Adult Patients Undergoing Open Colectomy MA402S23B303

NCT01507246 | Completed Phase 4 Results

• 1 other identifier: MA402S23B303
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Obstruction

Keywords

open colectomy

Outcome Measures

Primary Outcomes (3)

• Total Opioid Burden

  Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.

  Wound closure to time hospital discharge order written or Day 30, whichever is sooner

• Health Economic Benefits - Total Cost of Hospitalization

  Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.

  Wound closure to time hospital discharge order written or Day 30, whichever is sooner.

• Health Economic Benefits - Length of Stay

  Length of stay (LOS), recorded in hours and converted to days with one decimal of precision, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.

  Up to Day 30

Secondary Outcomes (1)

• Incidence of Predefined Opioid-related Adverse Events

  From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), which ever is sooner

Study Arms (2)

IV morphine sulfate

ACTIVE COMPARATOR

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

Drug: IV morphine sulfate

EXPAREL (bupivacaine liposome injectable suspension)

EXPERIMENTAL

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

Drug: EXPAREL (bupivacaine liposome injectable suspension)

Interventions

IV morphine sulfate 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.

Also known as: morphine sulfate (or Sponsor-approved equivalent)

IV morphine sulfate

EXPAREL (bupivacaine liposome injectable suspension) 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.

Also known as: bupivacaine free base

EXPAREL (bupivacaine liposome injectable suspension)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead
• Registrat-Mapi: collaborator

Study Sites (1)

Atlanta Colon and Rectal Surgery

Riverdale, Georgia, 30274, United States

Location

Related Publications (1)

• 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.

  PMID: 25018650 DERIVED

MeSH Terms

Conditions

Intestinal Obstruction

Interventions

Morphine

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Stephen Cohen, MD
• Organization: Atlanta Colon and Rectal Surgery

klong@atlantacolon.com

770-997-1975

Study Officials

• Stephen Cohen, M.D.

  Atlanta Colon and Rectal Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2011
• First Posted: January 10, 2012
• Study Start: December 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 8, 2013
• Results First Posted: May 8, 2013

Record last verified: 2013-05

Locations

US (1)