TAP-patients With Robotic Assisted Lap Prostatectomy

Study Overview
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Brief Summary
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The purpose of the study is to assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy.

Detailed Description
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Assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to provide prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy. The primary endpoint is the duration of abdominal analgesia from the infiltration into the TAP as measured by the time to the subject's first postsurgical opioid administration.

Official Title
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Evaluation of the Safety and Efficacy of EXPAREL When Administered by Infiltration Into the Transversus Abdominis Plane (TAP) for Prolonged Postsurgical Analgesia in Subjects Undergoing Robot-assisted Laparoscopic Prostatectomy

Conditions
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Postsurgical Pain, Analgesia, Prostatectomy

Intervention / Treatment
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* Drug: EXPAREL 20 mL
* Drug: EXPAREL 40 mL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male subjects, aged 18-75. American Society of Anesthesiology (ASA) physical status 1-3. Undergoing robot-assisted laparoscopic prostatectomy performed by a single surgeon (Ingolf Tuerk, MD). Subjects must be physically and mentally able to participate in the study and complete all study assessments. Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP infiltration. Exclusion Criteria: Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics. Inability to tolerate oxycodone with acetaminophen (e.g. Percocet). Any subject whose anatomy or surgical procedure in the opinion of the Investigator might preclude the potential successful performance of a TAP. Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study. Subjects who have received any investigational drug within 30 days prior to study drug administration or planned administration of another investigational product or procedure during their participation in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPAREL 20 mL (undiluted)<br>20 mL (266 mg) undiluted EXPAREL with 133 mg infiltrated on each the right and left side of the abdomen. | Drug: EXPAREL 20 mL<br>* EXPAREL 266 mg (undiluted)<br>* Other names: bupivacaine liposome injectable suspension;|
| Active Comparator: EXPAREL 40 mL (diluted)<br>20 mL (266 mg) EXPAREL diluted with an equal volume of preservative-free 0.9% normal saline to a total of 40 mL and infiltrated equally to the right and left side of the abdomen. | Drug: EXPAREL 40 mL<br>* EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL.<br>* Other names: bupivacaine liposome injectable suspension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Duration of Abdominal Analgesia From Infiltration Into the TAP |  | First postsurgical administration of an opioid | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Reported Postsurgical Pain | 11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain) | 1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP | 
| Physician/Healthcare Professional Assessed Postsurgical Pain | 11-point NRS (0-10, 0=no pain, 10=worst possible pain) | 1, 2, 6, 12, 24 hours after TAP | 
| Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96. | Number of pills | 48, 72, 96 hours | 
| Incidence of Prespecified Opioid-related Adverse Events | Number of subjects | Until hospital discharge order was written, anticipated at 24 hours. | 
| Overall Rating of Subject Satisfaction With Postsurgical Pain Control | Mean of subject satisfaction offered on a 5-point Likert scale (1 = extremely dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = extremely satisfied) | 24 hours, 72 hours, and day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAP, robot-assisted prostatectomy