A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Bowel Obstruction	Drug: morphine sulfate Drug: bupivacaine liposome extended-release injectable suspension	Phase 4


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

Resource links provided by NLM:

Drug Information available for: Morphine sulfate Sulfate ion Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:

Total Opioid Burden [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner ] [ Designated as safety issue: Yes ]
Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.
Health Economic Benefit [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner. ] [ Designated as safety issue: No ]
1. Total cost of hospitalization to time hospital discharge order is written or through Day 30, whichever is sooner.
2. 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.

Secondary Outcome Measures:

Incidence of Opioid-related Adverse Events [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
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.
Patient Satisfaction With Postsurgical Analgesia [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
Responses to one question pertaining to patient satisfaction with postsurgical pain management and four questions pertaining to postsurgical recovery following hospital discharge.


Enrollment:	2
Study Start Date:	March 2012
Study Completion Date:	July 2012
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Morphine sulfate morphine sulfate (or Sponsor-approved equivalent)	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. Other Name: morphine sulfate (or Sponsor-approved equivalent)
Experimental: EXPAREL EXPAREL (bupivacaine liposome extended-release injectable suspension)	Drug: 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. Other Name: bupivacaine free base

Arms

Assigned Interventions

Active Comparator: Morphine sulfate

morphine sulfate (or Sponsor-approved equivalent)

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.

Other Name: morphine sulfate (or Sponsor-approved equivalent)

Experimental: EXPAREL

EXPAREL (bupivacaine liposome extended-release injectable suspension)

Drug: 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.

Other Name: bupivacaine free base

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 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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507220

Locations


United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Pacira Pharmaceuticals, Inc

Registrat-Mapi

Investigators


Principal Investigator:	Sergio Bergese, MD	Ohio State University

More Information


Responsible Party:	Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT01507220 History of Changes
Other Study ID Numbers:	MA402S23B301
Study First Received:	October 24, 2011
Results First Received:	November 29, 2013
Last Updated:	January 19, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:


open colectomy

Additional relevant MeSH terms:


Intestinal Obstruction Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Bupivacaine Morphine Anesthetics, Local Anesthetics	Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Analgesics, Opioid Narcotics Analgesics

ClinicalTrials.gov processed this record on September 30, 2016

A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301 (IMPROVE-Open)