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

Primary Purpose

Bowel Obstruction

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

IV morphine sulfate or Sponsor-approved equivalent

EXPAREL

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Male or female, at least 18 years of age.
Patients scheduled to undergo laparoscopic segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy. (Note: patients who converted from a planned laparoscopic colectomy to an open colectomy were not eligible.)
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 or who are unwilling to use acceptable means of contraception for at least 1 month before and 1 month after dosing. Acceptable means of contraception include hormonal contraceptives (e.g., oral, injectable, implantable), effective barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, non-heterosexual lifestyle, or in a strictly monogamous relationship with a partner who has had a vasectomy.
Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
Participation in an 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, a patient was ineligible if he or she met the following criteria during surgery:

Patients who had any concurrent surgical procedure.
Patients with unplanned multiple segmental resections of large intestine.
Patients who converted from laparoscopic-assisted colectomy to traditional open colectomy.
Patients who had unplanned, temporary or permanent colostomies, ileostomies, or the like placed.
Patients who received intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
Patients who received Entereg.

Sites / Locations

Washington Hospital Center
University of Miami, Dept. Anesthesiology
Tampa General Hospital
Albany Medical College
The Ohio State University Medical Center
Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

IV Morphine Sulfate or Sponsor-approved Equivalent

EXPAREL

Arm Description

Standard of Care (SOC)

EXPAREL (bupivacaine liposome injectable suspension)

Outcomes

Primary Outcome Measures

Total Opioid Burden

Total opioid consumed (IV and PO) postsurgically until 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 was sooner.

Health Economic Benefits - Length of Stay (LOS)

Length of stay, recorded in days, 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 defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.

Patient Satisfaction With Pain Treatment After Surgery

Responses to question pertaining to patient satisfaction with pain treatment

Full Information

NCT ID

NCT02058290

First Posted

February 6, 2014

Last Updated

April 15, 2014

Sponsor

Pacira Pharmaceuticals, Inc

Collaborators

Registrat-Mapi

1. Study Identification

Unique Protocol Identification Number

NCT02058290

Brief Title

A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy

Acronym

IMPROVE-Lap

Official Title

A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation of Bupivacaine, EXPAREL(R): A Phase 4 Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy (IMPROVE-Lap Colectomy)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Terminated

Why Stopped

Slower than expected enrollment

Study Start Date

December 2011 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

February 2013 (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

Yes

5. Study Description

Brief Summary

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 hospital 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bowel Obstruction

Keywords

laparoscopic 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

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IV Morphine Sulfate or Sponsor-approved Equivalent

Arm Type

Active Comparator

Arm Description

Standard of Care (SOC)

Arm Title

EXPAREL

Arm Type

Experimental

Arm Description

EXPAREL (bupivacaine liposome injectable suspension)

Intervention Type

Drug

Intervention Name(s)

IV morphine sulfate or Sponsor-approved equivalent

Intervention Description

Patients 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 a floor if the stay in the PACU is less than one hour.

Intervention Type

Drug

Intervention Name(s)

EXPAREL

Other Intervention Name(s)

bupivacaine liposome injectable suspension

Intervention Description

Patients will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc 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 hospital discharge order is written or through Day 30, whichever is sooner.

Time Frame

Wound closure to time hospital discharge order is 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 was sooner.

Time Frame

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

Title

Health Economic Benefits - Length of Stay (LOS)

Description

Length of stay, recorded in days, 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 at time hospital discharge order is written or Day 30, whichever is sooner

Secondary Outcome Measure Information:

Title

Incidence of Opioid-related Adverse Events

Description

Time Frame

Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.

Title

Patient Satisfaction With Pain Treatment After Surgery

Description

Responses to question pertaining to patient satisfaction with pain treatment

Time Frame

Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, at least 18 years of age. Patients scheduled to undergo laparoscopic segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy. (Note: patients who converted from a planned laparoscopic colectomy to an open colectomy were not eligible.) 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 or who are unwilling to use acceptable means of contraception for at least 1 month before and 1 month after dosing. Acceptable means of contraception include hormonal contraceptives (e.g., oral, injectable, implantable), effective barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, non-heterosexual lifestyle, or in a strictly monogamous relationship with a partner who has had a vasectomy. Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study. Participation in an 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, a patient was ineligible if he or she met the following criteria during surgery: Patients who had any concurrent surgical procedure. Patients with unplanned multiple segmental resections of large intestine. Patients who converted from laparoscopic-assisted colectomy to traditional open colectomy. Patients who had unplanned, temporary or permanent colostomies, ileostomies, or the like placed. Patients who received intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents. Patients who received Entereg.

Overall Study Officials: