Clinical trial NCT01919190: EXPAREL Administered by Infiltration Into the TAP for Prolonged Postsurgical Analgesia in Lower Abdominal Surgeries
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2013-08-08
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Total Opioid Consumption Post Surgery (Cumulative Total) Until Discharge Readiness or Post Surgery Day 4
timeFrame: From surgery through 4 days postsurgery
measure: Overall Benefit of Analgesic Score (OBAS) at Day 3
timeFrame: Postsurgical day 1 through day 3
Secondary outcomes:
measure: Extent and Degree of Anesthetic Blockade
timeFrame: Prior to TAP, immediately postoperatively, and daily through discharge or Day 4
measure: Severity of Postsurgical Pain
timeFrame: Immediately in PACU postsurgery and prior to pain medication until discharge (or Day 4)
measure: Quality of Recovery
timeFrame: Daily through Post Op Day 4
measure: Frequency of Patient Calls Post-discharge
timeFrame: Post-discharge through 4 days postsurgery
Other outcomes:
Locations:
city: Winter Park
country: United States
facility: Florida Hospital
state: Florida
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Pittsfield
country: United States
facility: Berkshire Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Fairview Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC St. Margaret's Hospital
state: Pennsylvania
city: Houston
country: United States
facility: St. John Hospital
state: Texas
Study officials:
affiliation: Pacira Pharmaceuticals, Inc
name: Kay Warnott, RN
role: STUDY_DIRECTOR
References: