search
Back to results

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

Primary Purpose

Bowel Obstruction

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
morphine sulfate
bupivacaine liposome extended-release injectable suspension
Sponsored by
Pacira Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bowel Obstruction focused on measuring open colectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Morphine sulfate

EXPAREL

Arm Description

morphine sulfate (or Sponsor-approved equivalent)

EXPAREL (bupivacaine liposome extended-release injectable suspension)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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. .
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.

Full Information

First Posted
October 24, 2011
Last Updated
January 19, 2014
Sponsor
Pacira Pharmaceuticals, Inc
Collaborators
Registrat-Mapi
search

1. Study Identification

Unique Protocol Identification Number
NCT01507220
Brief Title
A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pacira Pharmaceuticals, Inc
Collaborators
Registrat-Mapi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Obstruction
Keywords
open colectomy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morphine sulfate
Arm Type
Active Comparator
Arm Description
morphine sulfate (or Sponsor-approved equivalent)
Arm Title
EXPAREL
Arm Type
Experimental
Arm Description
EXPAREL (bupivacaine liposome extended-release injectable suspension)
Intervention Type
Drug
Intervention Name(s)
morphine sulfate
Other Intervention Name(s)
morphine sulfate (or Sponsor-approved equivalent)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
bupivacaine liposome extended-release injectable suspension
Other Intervention Name(s)
bupivacaine free base
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Opioid Burden
Description
Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.
Time Frame
Wound closure to time hospital discharge order written or Day 30, whichever is sooner
Title
Health Economic Benefit
Description
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.
Time Frame
Wound closure to time hospital discharge order written or Day 30, whichever is sooner.
Secondary Outcome Measure Information:
Title
Incidence of Opioid-related Adverse Events
Description
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. .
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
Title
Patient Satisfaction With Postsurgical Analgesia
Description
Responses to one question pertaining to patient satisfaction with postsurgical pain management and four questions pertaining to postsurgical recovery following hospital discharge.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Bergese, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25018650
Citation
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.
Results Reference
derived

Learn more about this trial

A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301

We'll reach out to this number within 24 hrs