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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

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Trial Conditions
  • Pain
What is the purpose of this trial?

The study of the analgesic affect when infiltrated into the TAP for men undergoing prostatectomy.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18  - 75 

Gender:
Male

Eligibility

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.

Gender: Male
Steward Physician(s)
  • Andrew Sternlicht, MD
Trial Interventions
Drug
  • fentanyl
  • fentanyl, sufentanil
Physician Researcher

Investigator Name:

  • Andrew Sternlicht, MD

Other Information

Sponsor: Pacira Pharmaceuticals, Inc
Phase: Phase 4
Trial ID: NCT01582477
Volunteers:  Not Accepting Healthy Volunteers

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