Study to Evaluate the Pharmacokinetics and Safety of EXPAREL Administered as a Pectoral Plane Block in Women Undergoing Breast Augmentation
Study Details
Study Description
Brief Summary
This is a pilot, open label, single center study in 30 women undergoing breast augmentation. The study will assess and collect information on pharmacokinetics and safety of EXPAREL administered as a pectoral plane block.
A total of 15 subjects will be enrolled in each of the 2 cohorts.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 - EXPAREL A total of 15 subjects will be enrolled in this cohort. Subjects in this cohort will receive 20mL EXPAREL (266mg) with 30mL of saline |
Drug: Exparel Injectable Product
bupivacaine liposome injectable suspension
|
| Experimental: Cohort 2 - EXPAREL A total of 15 subjects will be enrolled. Subjects in this cohort will receive 20mL EXPAREL (266mg) with 30mL of 0.5% bupivacaine HCl (150mg) |
Drug: Exparel Injectable Product
bupivacaine liposome injectable suspension
Drug: Bupivacaine Hydrochloride
1.3%, 13.3 mg/mL
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetic 1 (area under the plasma concentration) [predose (up to 15 min before block), 15 min(±10min), 30 min(±5min), and 1(±15min), 2(±15min), 6(±30min), 10(±30min), 18(±1), 26(±1), 36(±2), 48(±2), 60(±2), 72(±3), and 96 (±3) hours from start of study drug administration]
Area under the plasma concentration-versus-time curve (AUC)
- Pharmacokinetic 2 (Cmax) [predose (up to 15 min before block), 15 min(±10min), 30 min(±5min), and 1(±15min), 2(±15min), 6(±30min), 10(±30min), 18(±1), 26(±1), 36(±2), 48(±2), 60(±2), 72(±3), and 96 (±3) hours from start of study drug administration]
Maximum plasma concentration
- Pharmacokinetic 3 (half-life) [predose (up to 15 min before block), 15 min(±10min), 30 min(±5min), and 1(±15min), 2(±15min), 6(±30min), 10(±30min), 18(±1), 26(±1), 36(±2), 48(±2), 60(±2), 72(±3), and 96 (±3) hours from start of study drug administration]
The apparent terminal elimination half-life (t1/2el)
- Pharmacokinetic 4 (apparent clearance) [predose (up to 15 min before block), 15 min(±10min), 30 min(±5min), and 1(±15min), 2(±15min), 6(±30min), 10(±30min), 18(±1), 26(±1), 36(±2), 48(±2), 60(±2), 72(±3), and 96 (±3) hours from start of study drug administration]
Apparent Clearance (CL/F)
- Pharmacokinetic 5 (Mean residence time) [predose (up to 15 min before block), 15 min(±10min), 30 min(±5min), and 1(±15min), 2(±15min), 6(±30min), 10(±30min), 18(±1), 26(±1), 36(±2), 48(±2), 60(±2), 72(±3), and 96 (±3) hours from start of study drug administration]
Mean residence time (MRT)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Women aged 18 or older, undergoing breast augmentation and are American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
-
Able to provide informed consent, adhere to the study schedule, and complete all study assessments
-
Body Mass Index ≥18 and ≤30 kg/m2
Exclusion Criteria:
-
Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine, NSAIDs)
-
Documented history of long-term diabetes (≥10 years) or severe peripheral vascular disease
-
Renal (serum creatinine level >2mg/dL [176.8 μmol/L]) or hepatic dysfunction (serum alanine or aspartame transferase > 3 times the upper limit of normal)
-
Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post dosing period for pain and which, in the investigator's opinion may confound the post dosing assessments
-
History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
-
Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
-
Previous participation in an EXPAREL study
-
Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
-
Currently pregnant, nursing, or planning to become pregnant during the study
-
Clinically significant medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other conditions that would constitute a contraindication to participation in the study
-
Currently on neuroleptic agent [e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.]
-
Chronic opioid use in the last 30 days (≥30 morphine equivalents/ day)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | HD Research | Bellaire | Texas | United States | 77401 |
Sponsors and Collaborators
- Pacira Pharmaceuticals, Inc
Investigators
- Study Director: Nayana Nagaraj, MD, PhD, MPH, Pacira Pharmaceuticals, Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 402-C-123