Postoperative PainPhase 4NCT03705065
Bupivacaine HCl PK and Safety in Augmentation Mammoplasty
A Phase 4 study testing Bupivacaine HCl in people with Postoperative Pain, run by Heron Therapeutics at 1 site in United States.
Trial summary
This is a Phase 4, randomized, open-label study of bupivacaine HCl administered either by instillation into the surgical site or by injection into the surgical site in subjects undergoing bilateral submuscular augmentation mammoplasty under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine HCl
- 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 Sep 2018to 5 Nov 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Is scheduled to undergo primary bilateral submuscular augmentation mammoplasty with saline or silicone smooth implants with a volume of 300 to 500 mL, inclusive.
- Has an American Society of Anesthesiologists Physical Status of I, II, or III.
- Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.
Who cannot join
- Has a planned concurrent surgical procedure (eg, mastopexy).
- Has a planned concurrent reconstructive procedure status post breast cancer therapy.
- Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain that is not strictly related to the augmentation mammoplasty.
- Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
- Has been administered bupivacaine within 5 days prior to the scheduled surgery.
- Has been administered any local anesthetic within 72 hours prior to the scheduled surgery.
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- Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.
- As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).
- Has uncontrolled anxiety, psychiatric, or neurological disorder.
- Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
- Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study at the discretion of the Sponsor. Subjects taking any marijuana (medical or recreational) are not allowed to participate in the study.
- Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives.
- Has undergone 3 or more surgeries within 12 months.
- Has a body mass index (BMI) >35 kg/m2.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hermann Drive Surgical Hospital
Houston, Texas, 77027
About this study
Official title: A Phase 4, Randomized, Open-Label Study of the Pharmacokinetics and Tolerability of Bupivacaine HCl Following One of Two Routes of Administration in Subjects Undergoing Augmentation Mammoplasty
This is a Phase 4, randomized, open-label study of bupivacaine HCl administered either by instillation into the surgical site or by injection into the surgical site in subjects undergoing bilateral submuscular augmentation mammoplasty under general anesthesia.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine HCl
- Keywords
- augmentation mammoplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HClDrug
Bupivacaine HCl without epinephrine 0.25%, 60 mL (30 mL per pectoral pocket)
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine HCI via instillation | Experimental | Bupivacaine HCI 150 mg via instillation (75 mg into each pectoral pocket) Receives: Drug: Bupivacaine HCl |
| Bupivacaine HCI via injection | Experimental | Bupivacaine HCI 150 mg via injection (75 mg into each pectoral pocket) Receives: Drug: Bupivacaine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed bupivacaine plasma concentration
Measured: Through 72 hours after start of study drug administration
AUClast
Area under the bupivacaine plasma concentration-time curve through 72 hours postdose
Measured: Through 72 hours after start of study drug administration
AUCinf
Area under the bupivacaine plasma concentration-time curve from the start of study drug administration extrapolated to infinity
Measured: Through 72 hours after start of study drug administration
Tmax
Time to maximum bupivacaine plasma concentration
Measured: Through 72 hours after start of study drug administration
λz
Apparent terminal elimination rate constant
Measured: Through 72 hours after start of study drug administration
t1/2el
Apparent terminal elimination half-life
Measured: Through 72 hours after 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 posted15 Oct 2018
- Study start19 Sep 2018
- Primary completion8 Oct 2018
- Study completion5 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heron Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705065
- Sponsor's protocol ID
- BUPI-502
- Status last verified
- Dec 2018
- First submitted
- 10 Oct 2018
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Randomized, Open-Label Study of the Pharmacokinetics and Tolerability of Bupivacaine HCl Following One of Two Routes of Administration in Subjects Undergoing Augmentation Mammoplasty
- ClinicalTrials.gov ID
- NCT03705065
- Acronym / sponsor ID
- BUPI-502
- Conditions
- Postoperative Pain
- Keywords
- augmentation mammoplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Heron TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 5 Nov 2018 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Posted 28 Oct 2026
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 Phase 4, randomized, open-label study of bupivacaine HCl administered either by instillation into the surgical site or by injection into the surgical site in subjects undergoing bilateral submuscular augmentation mammoplasty under general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine HCI via instillation | Experimental | Drug: Bupivacaine HClBupivacaine HCI 150 mg via instillation (75 mg into each pectoral pocket) |
| Bupivacaine HCI via injection | Experimental | Drug: Bupivacaine HClBupivacaine HCI 150 mg via injection (75 mg into each pectoral pocket) |
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)
- Is scheduled to undergo primary bilateral submuscular augmentation mammoplasty with saline or silicone smooth implants with a volume of 300 to 500 mL, inclusive.
- Has an American Society of Anesthesiologists Physical Status of I, II, or III.
- Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.
Key exclusion criteria (14 listed)
- Has a planned concurrent surgical procedure (eg, mastopexy).
- Has a planned concurrent reconstructive procedure status post breast cancer therapy.
- Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain that is not strictly related to the augmentation mammoplasty.
- Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
- Has been administered bupivacaine within 5 days prior to the scheduled surgery.
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 |
|---|---|---|
| Bupivacaine HClBupivacaine HCl without epinephrine 0.25%, 60 mL (30 mL per pectoral pocket) | Drug | Bupivacaine HCI via injection, Bupivacaine HCI via instillation |
Primary outcome
Cmax
Time frame: Through 72 hours after start of study drug administration
Maximum observed bupivacaine plasma concentration
AUClast
Time frame: Through 72 hours after start of study drug administration
Area under the bupivacaine plasma concentration-time curve through 72 hours postdose
AUCinf
Time frame: Through 72 hours after start of study drug administration
Area under the bupivacaine plasma concentration-time curve from the start of study drug administration extrapolated to infinity
Tmax
Time frame: Through 72 hours after start of study drug administration
Time to maximum bupivacaine plasma concentration
λz
Time frame: Through 72 hours after start of study drug administration
Apparent terminal elimination rate constant
t1/2el
Time frame: Through 72 hours after start of study drug administration
Apparent terminal elimination half-life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine HCl in people with Postoperative Pain, run by Heron Therapeutics 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 14 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 28 Oct 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cmax (time frame: Through 72 hours after start of study drug administration). The study lists 6 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 28 Oct 2026.