Skip to main content
OpenTrials
Completed

NCT Number: NCT01582477

TAP-patients With Robotic Assisted Lap Prostatectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Steward St. Elizabeth's

Brighton, Massachusetts, 02135, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EXPAREL 20 mL

Drug

EXPAREL 266 mg (undiluted)

Other names: bupivacaine liposome injectable suspension

EXPAREL 40 mL

Drug

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

Other names: bupivacaine liposome injectable suspension

Primary outcomes

  1. The Duration of Abdominal Analgesia From Infiltration Into the TAP

    Time frame: First postsurgical administration of an opioid

Secondary outcomes

  1. Subject Reported Postsurgical Pain

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

    11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain)

  2. Physician/Healthcare Professional Assessed Postsurgical Pain

    Time frame: 1, 2, 6, 12, 24 hours after TAP

    11-point NRS (0-10, 0=no pain, 10=worst possible pain)

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

    Time frame: 48, 72, 96 hours

    Number of pills

  4. Incidence of Prespecified Opioid-related Adverse Events

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

    Number of subjects

  5. Overall Rating of Subject Satisfaction With Postsurgical Pain Control

    Time frame: 24 hours, 72 hours, and day 10

    Mean of subject satisfaction offered on a 5-point Likert scale (1 = extremely dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = extremely satisfied)

Sponsors and collaborators

Lead sponsor

Pacira Pharmaceuticals, Inc

Industry

Registry information

Official study title

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 Laparoscopic Prostatectomy

Acronym: TAP

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2012
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.