A Health Economic Trial in Adult Patients Undergoing Lapa... | NCT02058290

NCT02058290

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Registrat-Mapi	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IV Morphine Sulfate or Sponsor-approved Equivalent	Active Comparator	Standard of Care (SOC)	Drug: IV morphine sulfate or Sponsor-approved equivalent
EXPAREL	Experimental	EXPAREL (bupivacaine liposome injectable suspension)	Drug: EXPAREL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IV morphine sulfate or Sponsor-approved equivalent	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Opioid Burden	Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.	Wound closure to time hospital discharge order is written or 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.	Wound closure to time hospital discharge order is written or Day 30, whichever is 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.	Wound closure at time hospital discharge order is written or Day 30, whichever is sooner

Secondary Outcomes

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

Eligibility Module

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.

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Edward C Lee, MD	Albany Medical College	Principal Investigator
Keith Candiotti, MD	University of Miami	Principal Investigator
Sergio Bergese, MD	Ohio State University	Principal Investigator
Eric M Haas, MD	The Methodist Hospital Research Institute	Principal Investigator
Jorge Marcet, MD	Tampa General Hospital	Principal Investigator
Anjali Kumar, MD	Medstar Health Research Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Washington Hospital Center		Washington D.C.	District of Columbia	20010	United States
University of Miami, Dept. Anesthesiology

PubMed Identifier	Type	Citation	Retractions
25018650	Derived	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.

Arm/Group Information

ID	Title	Description
FG000	IV Morphine Sulfate or Sponsor-approved Equivalent	Standard of Care (SOC) IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was 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 was less than one hour.
FG001	EXPAREL	EXPAREL (bupivacaine liposome injectable suspension) EXPAREL: Patients received 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 was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care. All patients were offered rescue analgesia, as needed.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	IV Morphine Sulfate or Sponsor-approved Equivalent	Standard of Care (SOC) IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was 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 was less than one hour.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Total Opioid Burden

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

Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	IV Morphine Sulfate or Sponsor-approved Equivalent	Standard of Care (SOC) IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was 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 was less than one hour.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IV Morphine Sulfate or Sponsor-approved Equivalent	Standard of Care (SOC) IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was 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 was less than one hour.

ID	Term
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids