EXPAREL Administered by Infiltration Into the TAP for Prolonged Postsurgical Analgesia in Lower Abdominal Surgeries

NCT ID: NCT01919190

Last Updated: 2021-07-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-02-28

Brief Summary

The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration in lower abdominal surgical procedures.

Detailed Description

The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration in lower abdominal surgical procedures; primary endpoint signal seen during pre-specified interim analysis.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EXPAREL

EXPAREL (266mg/20 ml) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP

Group Type: ACTIVE_COMPARATOR

EXPAREL

Intervention Type: DRUG

TAP with EXPAREL

Placebo

The placebo control will be established using a grade-2 sham, no infiltration will occur

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

EXPAREL

TAP with EXPAREL

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

bupivacaine liposome injectable suspension.; Placebo using grade-2 sham, no infiltration

Eligibility Criteria

Inclusion Criteria

• Males and females >18 years of age
• American Society of Anesthesiologists (ASA) physical status 1-3
• Undergoing either lower abdominal surgery defined as Laparoscopic Hysterectomy (female), Laparoscopic Myomectomy (female), Laparoscopic Colectomy (male/female)
• Physically and mentally able to give full informed consent to participate in this study and complete all study assessments within the timeframes required (including electronic diaries should patient be discharged prior to day 4)
• Capable of returning the diary after POD 4 by mail (preferably) or upon follow up visit.

Exclusion Criteria

• History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
• Any patient whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful local administration of EXPAREL.
• Patients who have received any investigational drug within 30 days prior to EXPAREL administration, or planned administration of another investigational product or procedure during their participation in this study.
• Any chronic condition requiring use of opioids for treatment of a medical condition for 2 weeks or more prior to surgery.
• Confirmed pregnancy at time of enrollment or breast feeding (females of child-bearing potential).
• Patients that would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.
• Any patient with diagnosed or potential metastatic disease.
• Any condition that in the investigator's opinion might be harmed or be a poor candidate for participation in the study (such as patients requiring long acting opioids as part of the induction medications).
• Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®)
• History of suspected or known addiction to, or abuse of, illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kay Warnott, RN

Role: STUDY_DIRECTOR

Pacira Pharmaceuticals, Inc

Locations

Florida Hospital

Winter Park, Florida, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Northwestern University

Chicago, Illinois, United States

University of Louisville

Louisville, Kentucky, United States

Berkshire Medical Center

Pittsfield, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Montefiore Medical Center

The Bronx, New York, United States

Duke University

Durham, North Carolina, United States

Fairview Hospital

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

UPMC St. Margaret's Hospital

Pittsburgh, Pennsylvania, United States

St. John Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

MSE402

Identifier Type: -

Identifier Source: org_study_id