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Adult Patients Undergoing Open Colectomy MA402S23B303 (IMPROVE-Open)

Primary Purpose

Bowel Obstruction

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV morphine sulfate
EXPAREL (bupivacaine liposome 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 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).

Sites / Locations

  • Atlanta Colon and Rectal Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

IV morphine sulfate

EXPAREL (bupivacaine liposome injectable suspension)

Arm Description

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

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

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 Benefits - Total Cost of Hospitalization
Total cost of hospitalization until the time hospital discharge order is written or through 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.

Secondary Outcome Measures

Incidence of Predefined Opioid-related Adverse Events
The incidence of predefined opioid-related adverse events

Full Information

First Posted
October 23, 2011
Last Updated
May 6, 2013
Sponsor
Pacira Pharmaceuticals, Inc
Collaborators
Registrat-Mapi
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1. Study Identification

Unique Protocol Identification Number
NCT01507246
Brief Title
Adult Patients Undergoing Open Colectomy MA402S23B303
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
May 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
August 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(R) 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 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.

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
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV morphine sulfate
Arm Type
Active Comparator
Arm Description
Standard of Care (SOC), dosage variable, administered intravenously via PCA pump postsurgically, as need.
Arm Title
EXPAREL (bupivacaine liposome injectable suspension)
Arm Type
Experimental
Arm Description
EXPAREL(R), dosage 266 mg, diluted with 0.9% saline to a total volume of 40 cc.
Intervention Type
Drug
Intervention Name(s)
IV morphine sulfate
Other Intervention Name(s)
morphine sulfate (or Sponsor-approved equivalent)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
EXPAREL (bupivacaine liposome 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 Benefits - Total Cost of Hospitalization
Description
Total cost of hospitalization until the time 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 Benefits - Length of Stay
Description
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.
Time Frame
Up to Day 30
Secondary Outcome Measure Information:
Title
Incidence of Predefined Opioid-related Adverse Events
Description
The incidence of predefined 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), which ever 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 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Cohen, M.D.
Organizational Affiliation
Atlanta Colon and Rectal Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta Colon and Rectal Surgery
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274
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

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Adult Patients Undergoing Open Colectomy MA402S23B303

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