TAP-patients With Robotic Assisted Lap Prostatectomy

NCT ID: NCT01582477

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-07-31

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.

Conditions

Postsurgical Pain; Analgesia; Prostatectomy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EXPAREL 20 mL (undiluted)

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

Group Type: EXPERIMENTAL

EXPAREL 20 mL

Intervention Type: DRUG

EXPAREL 266 mg (undiluted)

EXPAREL 40 mL (diluted)

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.

Group Type: ACTIVE_COMPARATOR

EXPAREL 40 mL

Intervention Type: DRUG

EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL.

Interventions

EXPAREL 20 mL

EXPAREL 266 mg (undiluted)

Intervention Type: DRUG

EXPAREL 40 mL

EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL.

Intervention Type: DRUG

Other Intervention Names

bupivacaine liposome injectable suspension; bupivacaine liposome injectable suspension

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Sternlicht, MD

Role: PRINCIPAL_INVESTIGATOR

Steward St. Elizabeth's

Locations

Steward St. Elizabeth's

Brighton, Massachusetts, United States

Countries

United States

Other Identifiers

MA402S23B701

Identifier Type: -

Identifier Source: org_study_id