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OpenTrials
Completed

NCT Number: NCT01801124

EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair

Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

About this study

This is a prospective, open-label, non-randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg EXPAREL to infiltrate into the TAP unilaterally.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males and females, aged 18-75 years inclusive, and ASA physical status 1-3.
  • Undergoing open repair of a unilateral abdominal hernia below the level of the umbilicus.
  • Abdominal incision length of 3-12 cm.
  • 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 proposed components of the TAP infiltration.

Exclusion criteria

  • History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
  • Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP infiltration.
  • Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
  • Any subject, who in the opinion of the Investigator, is on chronic pain medicine.
  • Any female subject who is currently pregnant.
  • 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

Drug

single dose 266 mg of undiluted EXPAREL

Other names: bupivacaine liposome injectable suspension

Primary outcomes

  1. Overall Postsurgical Analgesic Use

    Time frame: 10 days

    The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg)

Secondary outcomes

  1. Postsurgical AEs and SAEs Through Day 30.

    Time frame: 30 days

    Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.

Sponsors and collaborators

Lead sponsor

Pacira Pharmaceuticals, Inc

Industry

Registry information

Official study title

Evaluation of the Safety and Efficacy of EXPAREL® When Infiltrated Into the Transversus Abdominis Plane (TAP) for Prolonged Postoperative Analgesia in Subjects Undergoing Unilateral Abdominal Hernia Repair

Acronym: 702

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 28, 2013
Registry last updated
Mar 8, 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.

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