A Phase 1, Pilot, Open Label, Study to Evaluate the Pharmacokinetics, and Safety, of EXPAREL Administered as Pectoral Plane Block in Women Undergoing Breast Augmentation Surgery
Overview
- Phase
- Phase 1
- Intervention
- Exparel Injectable Product
- Conditions
- Breast Augmentation
- Sponsor
- Pacira Pharmaceuticals, Inc
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic 1 (area under the plasma concentration)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
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
Intervention: Exparel Injectable Product
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)
Intervention: Exparel Injectable Product
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)
Intervention: Bupivacaine Hydrochloride
Outcomes
Primary Outcomes
Pharmacokinetic 1 (area under the plasma concentration)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)