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

NCT ID: NCT04293809

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-19
• Study Completion Date: 2020-01-29

Brief 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.

Conditions

Breast Augmentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 - EXPAREL

A total of 15 subjects will be enrolled in this cohort. Subjects in this cohort will receive 20mL EXPAREL (266mg) with 30mL of saline

Group Type: EXPERIMENTAL

Exparel Injectable Product

Intervention Type: DRUG

bupivacaine liposome injectable suspension

Cohort 2 - EXPAREL

A total of 15 subjects will be enrolled. Subjects in this cohort will receive 20mL EXPAREL (266mg) with 30mL of 0.5% bupivacaine HCl (150mg)

Group Type: EXPERIMENTAL

Exparel Injectable Product

Intervention Type: DRUG

bupivacaine liposome injectable suspension

Bupivacaine Hydrochloride

Intervention Type: DRUG

1.3%, 13.3 mg/mL

Interventions

Exparel Injectable Product

bupivacaine liposome injectable suspension

Intervention Type: DRUG

Bupivacaine Hydrochloride

1.3%, 13.3 mg/mL

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nayana Nagaraj, MD, PhD, MPH

Role: STUDY_DIRECTOR

Pacira Pharmaceuticals, Inc

Locations

HD Research

Bellaire, Texas, United States

Countries

United States

Other Identifiers

402-C-123

Identifier Type: -

Identifier Source: org_study_id