TAP-patients With Robotic Assisted Lap Prostatectomy
Completed · Phase 4
Conditions studied: Postsurgical Pain, Analgesia, Prostatectomy
In brief
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.
Key facts
- Study ID
- NCT01582477
- Run by
- Pacira Pharmaceuticals, Inc
- People needed
- 24
- Starts
- 2012-03-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2021-06-14
Who can join
Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Steward St. Elizabeth's — Brighton, Massachusetts, United States
Full record on ClinicalTrials.gov
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