Phase 4
Completed N=19
Study of EXPAREL in Patients Undergoing Breast Augmentation
Mammoplasty · Postoperative Pain
Source: ClinicalTrials.gov NCT01582490 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Duration of Analgesia — 0.07; 0.3; 4.28; 4.82 hours
Summary
This is a Phase 4, prospective, open-label, non-randomized, sequential study with two treatment groups differing only in the technique used for EXPAREL administration (instillation or infiltration).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Analgesia |
0.07; 0.3; 4.28; 4.82 | — |
| SECONDARY Total Postsurgical Opioid Consumption in the Surgical Center |
4.5; 3.0 | — |
| SECONDARY Pain Intensity Assessment Upon Waking in the PACU |
4.5; 3.7 | — |
| SECONDARY Pain Intensity Assessment at the Time of Hospital Discharge |
3.8; 3.4 | — |
| SECONDARY Time to Hospital Discharge Being Written |
3.2; 3.11 | — |
| SECONDARY Incidence of Opioid-Related Adverse Events |
0; 0 | — |
| SECONDARY Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge |
1; 0; 1; 0; 0; 2 | — |
| SECONDARY Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10 |
2; 0; 1; 0; 1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Female, 18-75 years of age inclusive.
- American Society of Anesthesiologists (ASA) physical status 1-3.
- Undergoing bilateral augmentation mammoplasty without any concurrent surgical procedure(s).
- Physically and mentally able to participate in the study and complete all study assessments.
- Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the study components.
Exclusion Criteria
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
- Any subject whose anatomy or surgical procedure might, in the opinion of the Investigator, preclude the potential successful local administration of EXPAREL.
- Subjects currently pregnant or who may become pregnant during the course of the study.
- 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.
Data sourced from ClinicalTrials.gov (NCT01582490). 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. Informational only — not medical advice.