TAP-patients With Robotic Assisted Lap Prostatectomy

NCT01582477 | Completed Phase 4 Results

• 1 other identifier: MA402S23B701
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Postsurgical Pain; Analgesia; Prostatectomy

Keywords

TAP, robot-assisted prostatectomy

Outcome Measures

Primary Outcomes (1)

• The Duration of Abdominal Analgesia From Infiltration Into the TAP

  First postsurgical administration of an opioid

Secondary Outcomes (5)

• Subject Reported Postsurgical Pain

  1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP

• Physician/Healthcare Professional Assessed Postsurgical Pain

  1, 2, 6, 12, 24 hours after TAP

• Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.

  48, 72, 96 hours

• Incidence of Prespecified Opioid-related Adverse Events

  Until hospital discharge order was written, anticipated at 24 hours.

• Overall Rating of Subject Satisfaction With Postsurgical Pain Control

  24 hours, 72 hours, and day 10

Study Arms (2)

EXPAREL 20 mL (undiluted)

EXPERIMENTAL

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

Drug: EXPAREL 20 mL

EXPAREL 40 mL (diluted)

ACTIVE COMPARATOR

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.

Drug: EXPAREL 40 mL

Interventions

EXPAREL 20 mL DRUG

EXPAREL 266 mg (undiluted)

Also known as: bupivacaine liposome injectable suspension

EXPAREL 20 mL (undiluted)

EXPAREL 40 mL DRUG

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

Also known as: bupivacaine liposome injectable suspension

EXPAREL 40 mL (diluted)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

Steward St. Elizabeth's

Brighton, Massachusetts, 02135, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Andrew Sternlicht, MD
• Organization: St. Elizabeth's Medical Center

andrew.sternlicht@steward.org

617-789-2777

Study Officials

• Andrew Sternlicht, MD

  Steward St. Elizabeth's

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 20, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: June 14, 2021
• Results First Posted: June 10, 2013

Record last verified: 2021-06

Locations

US (1)