Postoperative PainPhase 2NCT03011333
Phase 2B Upper Extremity Nerve Block Study
A Phase 2 study testing HTX-011 and Bupivacaine HCl without epinephrine in people with Postoperative Pain, run by Heron Therapeutics at 2 sites in United States.
Trial summary
This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled, multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 when administered via ultrasound-guided lateral and medial pectoral nerve block… 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 and Bupivacaine HCl without epinephrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jan 2017to 19 Mar 2018
- 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 scheduled to undergo primary bilateral submuscular augmentation mammoplasty with saline or silicone smooth implants with a volume of 300 to 500 cc, inclusive. Note: textured implants are not allowed.
- Has an American Society of Anesthesiologists Physical Status of I, II, or III.
- 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.
- Has a planned 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.
- Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medication.
- Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
- Has taken NSAIDs within 10 days prior to scheduled surgery.
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- 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 other than to treat an AE that occurs after signing the ICF or for pretreatment prior to a needle placement.
- Has initiated treatment with any of the following medications within 1 month prior to study drug administration or is taking any of these medications to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, duloxetine, or cyclooxygenase-2 (COX-2) inhibitors. (Note: If a subject is taking one of these medications for a reason other than pain control, she must be on a stable scheduled dose [ie, not "as needed"] for at least 1 month prior to study drug administration.) Anxiolytics prior to surgery are permitted, if necessary.
- Has a medical condition 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 a known history of Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).
- Has uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
- Has any chronic neuromuscular deficit of either pectoral nerve function or arm/shoulder/truncal musculature.
- Has any chronic condition or disease that would compromise neurological or vascular assessments.
- Had a malignancy in the last year, with the exception of non-metastatic 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. Subjects taking medical marijuana 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 in 12 months.
- Has a body mass index (BMI) >35 kg/m2.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Houston, Texas, 77027
Study site
Pasadena, California, 91105
About this study
Official title: A Phase 2B, Randomized, Controlled Study of HTX-011 Administered Via Pectoral Nerve Block in Subjects Undergoing Upper Extremity Surgery for Augmentation Mammoplasty
This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled, multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 when administered via ultrasound-guided lateral and medial pectoral nerve block before surgery.
- Conditions
- Postoperative Pain
- Being tested
- HTX-011, Bupivacaine HCl without epinephrine, Saline Placebo
- 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
HTX-011 (bupivacaine/meloxicam) via nerve block or instillation.
Bupivacaine HCl without epinephrineDrug
Bupivacaine HCl without epinephrine, 50 mg via nerve block.
Saline PlaceboDrug
Saline placebo via nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: HTX-011 | Experimental | HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block. Receives: Drug: HTX-011 |
| Group 2: HTX-011 | Experimental | HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block. Receives: Drug: HTX-011 |
| Group 3: HTX-011 | Experimental | HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block. Receives: Drug: HTX-011 |
| Group 4: HTX-011 | Experimental | HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block. Receives: Drug: HTX-011 |
| Group 5: HTX-011 | Experimental | HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation. Receives: Drug: HTX-011 |
| Group 6: Bupivacaine HCl | Active comparator | Bupivacaine HCl without epinephrine, 50 mg via nerve block. Receives: Drug: Bupivacaine HCl without epinephrine |
| Group 7: Saline Placebo | Placebo comparator | Saline placebo via nerve block. Receives: Drug: Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 24 Hours Postsurgery (AUC0-24).
Pain intensity is assessed using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-24 is 0-240. The prescribed activity for NRS-A is keeping the elbows at the side and against the body and then raising both hands in front of the abdomen with hands clasped and holding that position for at least 5 seconds.
Measured: 24 hours
Secondary outcomes (1)
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)
Measured: 72 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start14 Jan 2017
- Primary completion1 Feb 2018
- Study completion19 Mar 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 243 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
- NCT03011333
- Sponsor's protocol ID
- HTX-011-211
- Status last verified
- Feb 2026
- First submitted
- 3 Jan 2017
- Last updated
- 2 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2B, Randomized, Controlled Study of HTX-011 Administered Via Pectoral Nerve Block in Subjects Undergoing Upper Extremity Surgery for Augmentation Mammoplasty
- ClinicalTrials.gov ID
- NCT03011333
- Acronym / sponsor ID
- HTX-011-211
- Conditions
- Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Heron TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Posted 29 Oct 2021
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 2B, randomized, assessor-blind, active- and saline placebo-controlled, multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 when administered via ultrasound-guided lateral and medial pectoral nerve block before surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1: HTX-011 | Experimental | Drug: HTX-011HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block. |
| Group 2: HTX-011 | Experimental | Drug: HTX-011HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block. |
| Group 3: HTX-011 | Experimental | Drug: HTX-011HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block. |
| Group 4: HTX-011 | Experimental | Drug: HTX-011HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block. |
| Group 5: HTX-011 | Experimental | Drug: HTX-011HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation. |
| Group 6: Bupivacaine HCl | Active comparator | Drug: Bupivacaine HCl without epinephrineBupivacaine HCl without epinephrine, 50 mg via nerve block. |
| Group 7: Saline Placebo | Placebo comparator | Drug: Saline PlaceboSaline placebo via nerve block. |
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 cc, inclusive. Note: textured implants are not allowed.
- Has an American Society of Anesthesiologists Physical Status of I, II, or III.
- 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 (19 listed)
- Has a planned concurrent surgical procedure.
- Has a planned 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.
- Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medication.
- Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
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-011HTX-011 (bupivacaine/meloxicam) via nerve block or instillation. | Drug | Group 1: HTX-011, Group 2: HTX-011, Group 3: HTX-011, Group 4: HTX-011, Group 5: HTX-011 |
| Bupivacaine HCl without epinephrineBupivacaine HCl without epinephrine, 50 mg via nerve block. | Drug | Group 6: Bupivacaine HCl |
| Saline PlaceboSaline placebo via nerve block. | Drug | Group 7: Saline Placebo |
Primary outcome
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 24 Hours Postsurgery (AUC0-24).
Time frame: 24 hours
Pain intensity is assessed using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-24 is 0-240. The prescribed activity for NRS-A is keeping the elbows at the side and against the body and then raising both hands in front of the abdomen with hands clasped and holding that position for at least 5 seconds.
1 secondary outcome
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)
Time frame: 72 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 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.
2 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 and Bupivacaine HCl without epinephrine in people with Postoperative Pain, run by Heron Therapeutics at 2 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 3 inclusion and 19 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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 29 Oct 2021). 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?
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 24 Hours Postsurgery (AUC0-24). (time frame: 24 hours). 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 2 Mar 2026.