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Completed

NCT Number: NCT04293809

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

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.

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Key information

Conditions

Breast Augmentation

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

HD Research

Bellaire, Texas, 77401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exparel Injectable Product

Drug

bupivacaine liposome injectable suspension

Bupivacaine Hydrochloride

Drug

1.3%, 13.3 mg/mL

Primary outcomes

  1. 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)

  2. 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

  3. 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)

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Pacira Pharmaceuticals, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 3, 2020
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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