Adult Patients Undergoing Open Colectomy MA402S23B303

Bowel Obstruction Clinical Trial

— IMPROVE-Open  

Official title:

A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation Of Bupivacaine, EXPAREL®: A Phase 4 Health Economic Trial in Adult Patients Undergoing Open Colectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507246
• Other study ID #: MA402S23B303
• Status: Completed
• Phase: Phase 4
• First received: October 23, 2011
• Last updated: May 6, 2013
• Start date: December 2011
• Est. completion date: August 2012

Study information

• Verified date: May 2013
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Bowel Obstruction
• Intestinal Obstruction

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Atlanta Colon and Rectal Surgery	Riverdale	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc	Registrat-Mapi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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.	No
Primary	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	No
Secondary	Incidence of Predefined Opioid-related Adverse Events	The 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	Yes