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Adult Patients Undergoing Open Colectomy MA402S23B303 (IMPROVE-Open)

This study has been completed.
Sponsor:
Collaborator:
Registrat-Mapi
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01507246
First received: October 23, 2011
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Bowel Obstruction
 Drug: IV morphine sulfate
Drug: EXPAREL (bupivacaine liposome injectable suspension)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial 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:

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 Benefits - Total Cost of Hospitalization [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to Day 30 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: Yes ]
    The incidence of predefined opioid-related adverse events


Enrollment: 42
Study Start Date: December 2011
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IV morphine sulfate
Standard of Care (SOC), dosage variable, administered intravenously via PCA pump postsurgically, as need.
 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.
Other Name: morphine sulfate (or Sponsor-approved equivalent)
Experimental: EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL(R), dosage 266 mg, diluted with 0.9% saline to a total volume of 40 cc.
 Drug: 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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507246

Locations
United States, Georgia
Atlanta Colon and Rectal Surgery
Riverdale, Georgia, United States, 30274
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Registrat-Mapi
Investigators
Principal Investigator: Stephen Cohen, M.D. Atlanta Colon and Rectal Surgery
  More Information

No publications provided

Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01507246     History of Changes
Other Study ID Numbers: MA402S23B303
Study First Received: October 23, 2011
Results First Received: February 26, 2013
Last Updated: May 6, 2013
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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Analgesics
Narcotics

ClinicalTrials.gov processed this record on May 22, 2013