TAP-patients With Robotic Assisted Lap Prostatectomy

Pacira

Status and phase: Completed; Phase 4

Conditions: Prostatectomy; Postsurgical Pain; Analgesia

Treatments: Drug: EXPAREL 40 mL; Drug: EXPAREL 20 mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT01582477

MA402S23B701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

EXPAREL 20 mL (undiluted)

Experimental group

Description:

20 mL (266 mg) undiluted EXPAREL with 133 mg infiltrated on each the right and left side of the abdomen.

Treatment:

Drug: EXPAREL 20 mL

EXPAREL 40 mL (diluted)

Active Comparator group

Description:

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.

Treatment:

Drug: EXPAREL 40 mL