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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pain

Intervention / Treatment
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* Drug: EXPAREL
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EXPAREL<br>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 | Drug: EXPAREL<br>* TAP with EXPAREL<br>* Other names: bupivacaine liposome injectable suspension.;|
| Sham Comparator: Placebo<br>The placebo control will be established using a grade-2 sham, no infiltration will occur | Drug: Placebo<br>* Placebo<br>* Other names: Placebo using grade-2 sham, no infiltration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Opioid Consumption Post Surgery (Cumulative Total) Until Discharge Readiness or Post Surgery Day 4 | Total Opioid Consumption Post Surgery (cumulative total) Until Discharge Readiness or Post Surgery Day 4 | From surgery through 4 days postsurgery | 
| Overall Benefit of Analgesic Score (OBAS) at Day 3 | Severity of postsurgical pain, satisfaction with pain management, and impact of opioid-related symptom distress measured using the Overall Benefit of Analgesic Score (OBAS) - primary endpoint is mean difference in OBAS at Day 3. (0=minimal pain and 4=maximum imaginable pain) | Postsurgical day 1 through day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent and Degree of Anesthetic Blockade | Extent and degree of anesthetic blockage measured using a 5-point sensation scale. | Prior to TAP, immediately postoperatively, and daily through discharge or Day 4 | 
| Severity of Postsurgical Pain | Severity of postsurgical pain measured using an 11-point numerical rating scale (NRS 0-10). | Immediately in PACU postsurgery and prior to pain medication until discharge (or Day 4) | 
| Quality of Recovery | Measured using the Quality of Recovery 15 questionnaire (QoR-15) | Daily through Post Op Day 4 | 
| Frequency of Patient Calls Post-discharge | Frequency of patient calls post-discharge related to pain and unscheduled hospital/surgeon visits | Post-discharge through 4 days postsurgery |