A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301

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: Terminated

Administrative data

• NCT number: NCT01507220
• Other study ID #: MA402S23B301
• Status: Terminated
• Phase: Phase 4
• First received: October 24, 2011
• Last updated: January 19, 2014
• Start date: March 2012
• Est. completion date: July 2012

Study information

• Verified date: January 2014
• 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 (bupivacaine liposome extended-release injectable suspension) 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 (bupivacaine liposome extended-release injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate for postsurgical analgesia in adult patients undergoing open colectomy with general anesthesia.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 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 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.

• 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 a 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, the patient will be ineligible if he or she meets the following criteria during surgery:

• Patients with unplanned multiple segmental resections of 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 any other analgesic, local anesthetics, or anti-inflammatory agents.

• Patients who receive Entereg(R).

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

Study Design

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

Related Conditions & MeSH terms

• Bowel Obstruction
• Intestinal Obstruction

Intervention

Drug:
• morphine sulfate
Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via 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 the floor if the stay in the PACU is less than 1 hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump.
• bupivacaine liposome extended-release 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	The Ohio State University	Columbus	Ohio

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 Benefit	Total cost of hospitalization to time hospital discharge order is written or through Day 30, whichever is sooner.; Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure 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.	No
Secondary	Incidence of Opioid-related Adverse Events	Incidence of opioid-related adverse events is defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.	From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), whichever is sooner	Yes
Secondary	Patient Satisfaction With Postsurgical Analgesia	Responses to one question pertaining to patient satisfaction with postsurgical pain management and four questions pertaining to postsurgical recovery following hospital discharge.	From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), whichever is sooner	Yes