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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT01919190

Run by

Pacira Pharmaceuticals, Inc

People needed

67

Starts

2013-08-01

Expected to finish

2014-02-01

Last updated by the study team

2021-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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