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



Status:Terminated
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:August 2013
End Date:February 2014

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Assessing the Impact of EXPAREL(R) on Opioid Use and Patient Reported Outcomes When Administered by Infiltration Into the Transversus Abdominis Plane (TAP) Under Ultrasound Guidance for Prolonged Postsurgical Analgesia in Lower Abdominal Surgeries

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.


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.
We found this trial at
13
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Durham, North Carolina 27710
(919) 684-8111
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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303 East Superior Street
Chicago, Illinois 60611
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Cleveland, Ohio 44111
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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Houston, Texas 77081
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Pittsburgh, Pennsylvania 15215
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Pittsfield, Massachusetts 01201
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4700 Waters Ave
Savannah, Georgia 31404
(912) 350-8000
Memorial Health University Medical Center Memorial University Medical Center (MUMC) is a nonprofit, 622-bed tertiary...
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Winter Park, Florida 32792
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