Postoperative PainPhase 2NCT03955211
PK and Safety After C-Section
A Phase 2 study testing HTX-011, ZYNRELEF kit components for administration and MMA regimen in people with Postoperative Pain, run by Heron Therapeutics at 4 sites in United States.
Trial summary
The main goal of the study was to measure the amount of the active ingredients and other components of HTX-011 in plasma and expressed breast milk over time following postpartum administration in women undergoing a planned C-section. The study also looked at the safety of HTX-011 in these women. 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?
- HTX-011, ZYNRELEF kit components for administration and MMA regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Jun 2019to 27 Dec 2021
- Phase
- Phase 2
- 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 expected, at the time of Screening visit, to deliver a single neonate.
- Is scheduled to undergo a planned C-section surgery with a low transverse skin incision (eg, Pfannenstiel).
- Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
- Agrees to practice abstinence or use double-barrier contraception in the event of sexual activity and commits to the use of an acceptable form of birth control for 30 days after HTX-011 administration.
- Agrees to refrain from the use of breast milk from this pregnancy in any manner.
Who cannot join
- Has planned to breastfeed her neonate at any time during the 28-day period after HTX-011 administration.
- Has had a prior full-term pregnancy with unsuccessful breast milk expression.
- Has a planned concurrent surgical procedure.
- 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.
Show all 18Show fewer
- Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.
- Has initiated treatment with study medications within 1 month prior to study drug administration that can impact pain control.
- Has taken any NSAIDs within least 10 days prior to the scheduled surgery.
- Has current significant placental abnormality/complications including, but not limited to, placenta previa or placenta accreta.
- 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.
- 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.
- Previously participated in an HTX-011 study.
- Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives.
- Weight is <50 kg at the time of Screening visit.
- In the Investigator's judgment, subject is likely to have been morbidly obese prior to her pregnancy.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Duke University Medical Center
Durham, North Carolina, 27710
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123
Helen Keller Hospital
Sheffield, Alabama, 35660
About this study
Official title: A Phase 2, Open-Label Study of the Pharmacokinetics and Safety of HTX-011 Administered Postpartum to Women Undergoing a Planned Caesarean Section
The main goal of the study was to measure the amount of the active ingredients and other components of HTX-011 in plasma and expressed breast milk over time following postpartum administration in women undergoing a planned C-section. The study also looked at the safety of HTX-011 in these women.
- Conditions
- Postoperative Pain
- Being tested
- HTX-011, ZYNRELEF kit components for administration, MMA regimen
- Keywords
- postoperative pain, caesarean section, C-section
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTX-011Drug
Also called ZYNRELEF
bupivacaine/meloxicam extended-release solution for instillation use, supplied in commercially available ZYNRELEF kits
ZYNRELEF kit components for administrationDevice
ZYNRELEF kits include sterile, individually packaged components for administration, including vented vial spikes, Luer lock syringes, custom Luer lock applicators, and syringe tip caps.
MMA regimenDrug
Also called ibuprofen, acetaminophen
PO ibuprofen 400 mg every 6 hours (q6h), alternating with PO acetaminophen 975 mg to 1 g q6h, alternating the 2 medications so that an analgesic was taken approximately every 3 hours (q3h) while the subject was awake
| Study group | Role | What they receive |
|---|---|---|
| HTX-011 300 mg/9 mg | Experimental | HTX-011 (bupivacaine/meloxicam) 300 mg/9 mg via instillation Receives: Drug: HTX-011; Device: ZYNRELEF kit components for administration |
| HTX-011 400 mg/12 mg + MMA | Experimental | HTX-011 (bupivacaine/meloxicam) 400 mg/12 mg via instillation + oral (PO) non-opioid multimodal analgesic (MMA) regimen Receives: Drug: HTX-011; Device: ZYNRELEF kit components for administration; Drug: MMA regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bupivacaine Plasma Cmax
Maximum plasma concentration of bupivacaine
Measured: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Bupivacaine Plasma Tmax
Time to maximum concentration of bupivacaine in plasma
Measured: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Bupivacaine Plasma t1/2
Half life of bupivacaine in plasma
Measured: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Bupivacaine Plasma AUCinf
Area under the bupivacaine plasma concentration-time curve from Time 0 extrapolated to infinity
Measured: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Bupivacaine Breast Milk Cmax
Maximum concentration of bupivacaine in breast milk
Measured: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Bupivacaine Breast Milk Tmax
Time to maximum concentration of bupivacaine in breast milk
Measured: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Bupivacaine Breast Milk AUClast
Area under the bupivacaine breast milk concentration-time curve from Time 0 to time of last quantifiable concentration
Measured: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Meloxicam Plasma Cmax
Maximum plasma concentrations of meloxicam
Measured: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Meloxicam Plasma Tmax
Time to maximum meloxicam plasma concentration in plasma
Measured: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Meloxicam Plasma t1/2
Half-life of meloxicam in plasma
Measured: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Meloxicam Plasma AUCinf
Area under the meloxicam plasma concentration-time curve from Time 0 extrapolated to infinity
Measured: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Meloxicam Breast Milk Cmax
Maximum concentration of meloxicam in breast milk
Measured: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Meloxicam Breast Milk Tmax
Time to maximum meloxicam concentration in breast milk
Measured: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Meloxicam Breast Milk AUClast
Area under the meloxicam breast milk concentration-time curve from Time 0 to time of last quantifiable concentration
Measured: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start24 Jun 2019
- Primary completion3 Dec 2021
- Study completion27 Dec 2021
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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT03955211
- Sponsor's protocol ID
- HTX-011-220
- Status last verified
- Dec 2022
- First submitted
- 9 May 2019
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label Study of the Pharmacokinetics and Safety of HTX-011 Administered Postpartum to Women Undergoing a Planned Caesarean Section
- ClinicalTrials.gov ID
- NCT03955211
- Acronym / sponsor ID
- HTX-011-220
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain, caesarean section, C-section
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Heron TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 27 Dec 2021 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Posted 27 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of the study was to measure the amount of the active ingredients and other components of HTX-011 in plasma and expressed breast milk over time following postpartum administration in women undergoing a planned C-section. The study also looked at the safety of HTX-011 in these women.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HTX-011 300 mg/9 mg | Experimental | Drug: HTX-011, Device: ZYNRELEF kit components for administrationHTX-011 (bupivacaine/meloxicam) 300 mg/9 mg via instillation |
| HTX-011 400 mg/12 mg + MMA | Experimental | Drug: HTX-011, Device: ZYNRELEF kit components for administration, Drug: MMA regimenHTX-011 (bupivacaine/meloxicam) 400 mg/12 mg via instillation + oral (PO) non-opioid multimodal analgesic (MMA) regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is expected, at the time of Screening visit, to deliver a single neonate.
- Is scheduled to undergo a planned C-section surgery with a low transverse skin incision (eg, Pfannenstiel).
- Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
- Agrees to practice abstinence or use double-barrier contraception in the event of sexual activity and commits to the use of an acceptable form of birth control for 30 days after HTX-011 administration.
- Agrees to refrain from the use of breast milk from this pregnancy in any manner.
Key exclusion criteria (18 listed)
- Has planned to breastfeed her neonate at any time during the 28-day period after HTX-011 administration.
- Has had a prior full-term pregnancy with unsuccessful breast milk expression.
- Has a planned concurrent surgical procedure.
- 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 |
|---|---|---|
| HTX-011Also: ZYNRELEFbupivacaine/meloxicam extended-release solution for instillation use, supplied in commercially available ZYNRELEF kits | Drug | HTX-011 300 mg/9 mg, HTX-011 400 mg/12 mg + MMA |
| ZYNRELEF kit components for administrationZYNRELEF kits include sterile, individually packaged components for administration, including vented vial spikes, Luer lock syringes, custom Luer lock applicators, and syringe tip caps. | Device | HTX-011 300 mg/9 mg, HTX-011 400 mg/12 mg + MMA |
| MMA regimenAlso: ibuprofen, acetaminophenPO ibuprofen 400 mg every 6 hours (q6h), alternating with PO acetaminophen 975 mg to 1 g q6h, alternating the 2 medications so that an analgesic was taken approximately every 3 hours (q3h) while the subject was awake | Drug | HTX-011 400 mg/12 mg + MMA |
Primary outcome
Bupivacaine Plasma Cmax
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Maximum plasma concentration of bupivacaine
Bupivacaine Plasma Tmax
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Time to maximum concentration of bupivacaine in plasma
Bupivacaine Plasma t1/2
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Half life of bupivacaine in plasma
Bupivacaine Plasma AUCinf
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Area under the bupivacaine plasma concentration-time curve from Time 0 extrapolated to infinity
Bupivacaine Breast Milk Cmax
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Maximum concentration of bupivacaine in breast milk
Bupivacaine Breast Milk Tmax
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Time to maximum concentration of bupivacaine in breast milk
Bupivacaine Breast Milk AUClast
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Area under the bupivacaine breast milk concentration-time curve from Time 0 to time of last quantifiable concentration
Meloxicam Plasma Cmax
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Maximum plasma concentrations of meloxicam
Meloxicam Plasma Tmax
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Time to maximum meloxicam plasma concentration in plasma
Meloxicam Plasma t1/2
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Half-life of meloxicam in plasma
Meloxicam Plasma AUCinf
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Area under the meloxicam plasma concentration-time curve from Time 0 extrapolated to infinity
Meloxicam Breast Milk Cmax
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Maximum concentration of meloxicam in breast milk
Meloxicam Breast Milk Tmax
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Time to maximum meloxicam concentration in breast milk
Meloxicam Breast Milk AUClast
Time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Area under the meloxicam breast milk concentration-time curve from Time 0 to time of last quantifiable concentration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HTX-011, ZYNRELEF kit components for administration and MMA regimen in people with Postoperative Pain, run by Heron Therapeutics at 4 sites 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 5 inclusion and 18 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 27 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 4 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 27 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?
Bupivacaine Plasma Cmax (time frame: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2). The study lists 14 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 27 Oct 2026.