Clinical trial NCT01582477: TAP-patients With Robotic Assisted Lap Prostatectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postsurgical Pain
Analgesia
Prostatectomy
Keywords: TAP, robot-assisted prostatectomy
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2012-04-20
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Duration of Abdominal Analgesia From Infiltration Into the TAP
timeFrame: First postsurgical administration of an opioid
Secondary outcomes:
measure: Subject Reported Postsurgical Pain
timeFrame: 1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP
measure: Physician/Healthcare Professional Assessed Postsurgical Pain
timeFrame: 1, 2, 6, 12, 24 hours after TAP
measure: Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.
timeFrame: 48, 72, 96 hours
measure: Incidence of Prespecified Opioid-related Adverse Events
timeFrame: Until hospital discharge order was written, anticipated at 24 hours.
measure: Overall Rating of Subject Satisfaction With Postsurgical Pain Control
timeFrame: 24 hours, 72 hours, and day 10
Other outcomes:
Locations:
city: Brighton
country: United States
facility: Steward St. Elizabeth's
state: Massachusetts
Study officials:
affiliation: Steward St. Elizabeth's
name: Andrew Sternlicht, MD
role: PRINCIPAL_INVESTIGATOR
References: