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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04293809
Other study ID # 402-C-123
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 19, 2019
Est. completion date January 29, 2020

Study information

Verified date January 2024
Source Pacira Pharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 29, 2020
Est. primary completion date January 15, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Exparel Injectable Product
bupivacaine liposome injectable suspension
Bupivacaine Hydrochloride
1.3%, 13.3 mg/mL

Locations

Country Name City State
United States HD Research Bellaire Texas

Sponsors (1)

Lead Sponsor Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetic 1 (area under the plasma concentration) Area under the plasma concentration-versus-time curve (AUC) 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
Primary Pharmacokinetic 2 (Cmax) Maximum 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
Primary Pharmacokinetic 3 (half-life) The apparent terminal elimination half-life (t1/2el) 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
Primary Pharmacokinetic 4 (apparent clearance) Apparent Clearance (CL/F) 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
Primary Pharmacokinetic 5 (Mean residence time) Mean residence time (MRT) 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
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