Breast AugmentationPhase 1NCT04293809
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL Administered as a Pectoral Plane Block in Women Undergoing Breast Augmentation
A Phase 1 study testing Exparel Injectable Product and Bupivacaine Hydrochloride in people with Breast Augmentation, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Augmentation
- What is being tested?
- Exparel Injectable Product and Bupivacaine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2019to 29 Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Exparel Injectable Product, Bupivacaine Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exparel Injectable ProductDrug
bupivacaine liposome injectable suspension
Bupivacaine HydrochlorideDrug
1.3%, 13.3 mg/mL
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - EXPAREL | Experimental | A total of 15 subjects will be enrolled in this cohort. Subjects in this cohort will receive 20mL EXPAREL (266mg) with 30mL of saline Receives: Drug: Exparel Injectable Product |
| Cohort 2 - EXPAREL | Experimental | 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) Receives: Drug: Exparel Injectable Product; Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic 1 (area under the plasma concentration)
Area under the plasma concentration-versus-time curve (AUC)
Measured: 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
Pharmacokinetic 2 (Cmax)
Maximum plasma concentration
Measured: 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
Pharmacokinetic 3 (half-life)
The apparent terminal elimination half-life (t1/2el)
Measured: 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
Pharmacokinetic 4 (apparent clearance)
Apparent Clearance (CL/F)
Measured: 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
Pharmacokinetic 5 (Mean residence time)
Mean residence time (MRT)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start19 Dec 2019
- Primary completion15 Jan 2020
- Study completion29 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nayana Nagaraj, MD, PhD, MPH, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293809
- Sponsor's protocol ID
- 402-C-123
- Status last verified
- Jan 2024
- First submitted
- 29 Feb 2020
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04293809
- Acronym / sponsor ID
- 402-C-123
- Conditions
- Breast Augmentation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 29 Jan 2020 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - EXPAREL | Experimental | Drug: Exparel Injectable ProductA total of 15 subjects will be enrolled in this cohort. Subjects in this cohort will receive 20mL EXPAREL (266mg) with 30mL of saline |
| Cohort 2 - EXPAREL | Experimental | Drug: Exparel Injectable Product, Drug: Bupivacaine HydrochlorideA total of 15 subjects will be enrolled. Subjects in this cohort will receive 20mL EXPAREL (266mg) with 30mL of 0.5% bupivacaine HCl (150mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exparel Injectable Productbupivacaine liposome injectable suspension | Drug | Cohort 1 - EXPAREL, Cohort 2 - EXPAREL |
| Bupivacaine Hydrochloride1.3%, 13.3 mg/mL | Drug | Cohort 2 - EXPAREL |
Primary outcome
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)
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
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayana Nagaraj, MD, PhD, MPH study director
Pacira Pharmaceuticals, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exparel Injectable Product and Bupivacaine Hydrochloride in people with Breast Augmentation, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.