Skip to main content
OpenTrials
Completed

NCT Number: NCT01507246

Adult Patients Undergoing Open Colectomy MA402S23B303

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bowel Obstruction Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Intestinal Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Atlanta Colon and Rectal Surgery

Riverdale, Georgia, 30274, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

IV morphine sulfate

Drug

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 names: morphine sulfate (or Sponsor-approved equivalent)

EXPAREL (bupivacaine liposome injectable suspension)

Drug

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 names: bupivacaine free base

Primary outcomes

  1. Total Opioid Burden

    Time frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner

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

  2. Health Economic Benefits - Total Cost of Hospitalization

    Time frame: Wound closure to time hospital discharge order written or Day 30, whichever is sooner.

    Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.

  3. Health Economic Benefits - Length of Stay

    Time frame: Up to Day 30

    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 outcomes

  1. 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

    The incidence of predefined opioid-related adverse events

Sponsors and collaborators

Lead sponsor

Pacira Pharmaceuticals, Inc

Industry

Collaborators

  • Registrat-Mapi

Registry information

Official study 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

Acronym: IMPROVE-Open

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 10, 2012
Registry last updated
May 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.