Phase 4
N=13
EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair
Hernia
Bottom Line
View on ClinicalTrials.gov: NCT01801124 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Overall Postsurgical Analgesic Use — 9.7 mg (morphine equivalents)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- EXPAREL (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pacira Pharmaceuticals, Inc
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Postsurgical Analgesic Use |
9.7 | — |
| SECONDARY Postsurgical AEs and SAEs Through Day 30. |
— | — |
Summary
Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01801124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.