Study to Evaluate the Pharmacokinetics and Safety of EXPAREL Administered as a Pectoral Plane Block in Women Undergoing Breast Augmentation

Phase 1

Completed

• Conditions: Breast Augmentation
• Interventions: Drug: Exparel Injectable Product; Drug: Bupivacaine Hydrochloride

• Registration Number: NCT04293809
• Lead Sponsor: Pacira Pharmaceuticals, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-19
• Primary Completion: 2020-01-15
• Study Completion: 2020-01-29
• Study First Submitted: 2020-02-29
• Study First Submitted QC: 2020-02-29
• Study First Posted: 2020-03-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Women aged 18 or older, undergoing breast augmentation and are American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
2. Able to provide informed consent, adhere to the study schedule, and complete all study assessments
3. Body Mass Index ≥18 and ≤30 kg/m2

Exclusion Criteria

1. 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)
2. Documented history of long-term diabetes (≥10 years) or severe peripheral vascular disease
3. 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)
4. 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
5. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
6. 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
7. Previous participation in an EXPAREL study
8. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
9. Currently pregnant, nursing, or planning to become pregnant during the study
10. 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
11. Currently on neuroleptic agent [e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.]
12. Chronic opioid use in the last 30 days (≥30 morphine equivalents/ day)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 2 - EXPAREL	Exparel Injectable Product	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)
Cohort 1 - EXPAREL	Exparel Injectable Product	A total of 15 subjects will be enrolled in this cohort. Subjects in this cohort will receive 20mL EXPAREL (266mg) with 30mL of saline
Cohort 2 - EXPAREL	Bupivacaine Hydrochloride	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)

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

HD Research; 🇺🇸 Bellaire, Texas, United States