Study to Evaluate the Pharmacokinetics and Safety of EXPAREL Administered as a Pectoral Plane Blo… (NCT04293809) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL Administered as a Pectoral Plane Block in Women Undergoing Breast Augmentation
United States30 participantsStarted 2019-12-19
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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
What they're measuring
1
Pharmacokinetic 1 (area under the plasma concentration)
Timeframe: 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
2
Pharmacokinetic 2 (Cmax)
Timeframe: 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
3
Pharmacokinetic 3 (half-life)
Timeframe: 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
4
Pharmacokinetic 4 (apparent clearance)
Timeframe: 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
5
Pharmacokinetic 5 (Mean residence time)
Timeframe: 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
✕. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance