TAP-patients With Robotic Assisted Lap Prostatectomy
Information source: Pacira Pharmaceuticals, Inc
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: fentanyl (Drug); fentanyl, sufentanil (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Pacira Pharmaceuticals, Inc Official(s) and/or principal investigator(s):
Andrew Sternlicht, MD, Principal Investigator, Affiliation: Steward St. Elizabeth's
Overall contact:
Jocelyn Wise, Email: jocelyn.wise@steward.org
Summary
The study of the analgesic affect when infiltrated into the TAP for men undergoing
prostatectomy.
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The duration of abdominal analgesia from infiltration into the TAP
Secondary outcome: assess the volume of EXPAREL infiltrated into the TAP influences the duration of analgesia
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- male subjects, aged 18-75
- 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.
Locations and Contacts
Jocelyn Wise, Email: jocelyn.wise@steward.org
Steward St. Elizabeth's, Brighton, Massachusetts 02135, United States; Recruiting
Jocelyn Wise, Email: jocelyn.wise@steward.org
Max Shapiro, Email: max.shapiro@steward.org
Andrew Sternlicht, MD, Principal Investigator
Additional Information
Starting date: March 2012
Last updated: April 19, 2012
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