EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair (702)

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Pacira

Status and phase

Completed
Phase 4

Conditions

Hernia

Treatments

Drug: EXPAREL

Study type

Interventional

Funder types

Industry

Identifiers

NCT01801124
MA402S23B702

Details and patient eligibility

About

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

Full description

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.

Enrollment

13 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

EXPAREL
Experimental group
Description:
undiluted EXPAREL 266 mg
Treatment:
Drug: EXPAREL

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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