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

Breast Augmentation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293809
• Other study ID #: 402-C-123
• Status: Completed
• Phase: Phase 1
• 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
• 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)

Related Conditions & MeSH terms

• Breast Augmentation

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