Overview

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

Status:
Completed
Trial end date:
2020-01-29
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Treatments:
Bupivacaine
Criteria
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)