A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy (IMPROVE-Lap Colectomy) - Full Text View

Purpose

This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome 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: IV morphine sulfate or Sponsor-approved equivalent Drug: EXPAREL	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 Laparoscopic Colectomy (IMPROVE - Lap Colectomy)

Resource links provided by NLM:

MedlinePlus related topics: Intestinal Obstruction

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 is written or Day 30, whichever is sooner ] [ Designated as safety issue: Yes ]
Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.
Health economic benefits [ Time Frame: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner. ] [ Designated as safety issue: No ]
1. Total cost of hospitalization until the 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 and patient satisfaction with postsurgical analgesia. [ Time Frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner. ] [ Designated as safety issue: Yes ]
1. Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.
2. Responses to one question pertaining to patient satisfaction with postsurgical analgesia and four questions pertaining to postsurgical recovery following hospital discharge.

Estimated Enrollment:	60
Study Start Date:	March 2012
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: IV Morphine Sulfate or Sponsor-approved Equivalent Standard of Care (SOC)	Drug: IV morphine sulfate or Sponsor-approved equivalent Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a 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 one hour.
Experimental: EXPAREL EXPAREL (bupivacaine liposome injectable suspension)	Drug: EXPAREL Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 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 stie's standard of care. All patient will be offered rescue analgesia, as needed. Other Name: bupivacaine liposome injectable suspension

Arms

Assigned Interventions

Active Comparator: IV Morphine Sulfate or Sponsor-approved Equivalent

Standard of Care (SOC)

Drug: IV morphine sulfate or Sponsor-approved equivalent

Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a 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 one hour.

Experimental: EXPAREL

EXPAREL (bupivacaine liposome injectable suspension)

Drug: EXPAREL

Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 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 stie's standard of care.

All patient will be offered rescue analgesia, as needed.

Other Name: bupivacaine liposome injectable suspension

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 injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or Sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing laparoscopic 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 laparoscopic-assisted colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy. (Note: patients who convert from a planned laparoscopic colectomy to an open colectomy are not eligible)
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.

In addition, the patient will be ineligible if he/she meets the following criteria during surgery:

Patients who have any concurrent procedure.
Patients with unplanned multiple segmental resections of large intestine.
Patients who convert from laparoscopic-assisted colectomy to traditional open colectomy.
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509820

Locations

United States, Texas
Methodist Hospital
Houston, Texas, United States, 77030
St. Luke's Hospital
Houston, Texas, United States, 77030

Sponsors and Collaborators

Pacira Pharmaceuticals, Inc

Registrat-Mapi

Investigators

Principal Investigator:

Eric M Haas, M.D.

The Methodist Hospital System

More Information

No publications provided

Responsible Party:	Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT01509820 History of Changes
Other Study ID Numbers:	MA402S23B606
Study First Received:	October 24, 2011
Last Updated:	May 15, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:

colectomy
laparoscopic 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 23, 2013