A Phase 1/2 interventional study of HTX-034 low dose and HTX-034 high dose in Bunions and Postoperative Pain, sponsored by Heron Therapeutics. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Heron Therapeutics · Phase 1/2, Interventional, and Prevention
This was a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b evaluated escalating doses of HTX-034 compared with bupivacaine HCl. Phase 2 was a dose-expansion phase to evaluate additional subjects treated with the HTX-034 dose selected based on Phase 1b, compared with bupivacaine HCl.
58 studies on the registry are indexed under Bunion; 5 are open to participants now.
This study's enrollment of 78 is below the median of 100 across 47 interventional studies indexed under Bunion.
Browse Bunion studies →Heron Therapeutics is the lead sponsor of 26 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 12 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Has any of the following laboratory abnormalities during Screening (1 retest permitted):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg (bupivacaine/aprepitant/meloxicam doses).
Drug: HTX-034 low dose · Device: Luer lock applicator
Individualized high dose of HTX-034: ranging from 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg (bupivacaine/aprepitant/meloxicam doses).
Drug: HTX-034 high dose · Device: Luer lock applicator
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg (bupivacaine/aprepitant/meloxicam doses).
Drug: HTX-034 low dose · Device: Luer lock applicator
Individualized high dose of HTX-034: ranging from 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg (bupivacaine/aprepitant/meloxicam doses).
Drug: HTX-034 high dose · Device: Luer lock applicator
Bupivacaine HCl (without epinephrine) 0.5%: 50 mg
Drug: Bupivacaine HCl
HTX-034 (bupivacaine/aprepitant/meloxicam) fixed dose: 21.7 mg/4.3 mg/0.6 mg
HTX-034 (bupivacaine/aprepitant/meloxicam) individualized dose: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg
Applicator for instillation
Bupivacaine HCl 50 mg
Incidence of TEAEs in Phases 1b/2
The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Time frame: 42 days
AUC0-72 of Pain Scores
Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) of pain intensity scores with activity (windowed worst observation carried forward) through 72 hours. The NRS was an 11-point scale (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Time frame: through 72 hours
Cmax for HTX-034
Maximum plasma concentration
Time frame: 29 days
Tmax for HTX-034
Time of maximum plasma concentration
Time frame: 29 days
AUClast for HTX-034
Area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration
Time frame: 29 days
AUCinf for HTX-034
Area under the concentration-time curve from Time 0 extrapolated to infinity (Phase 1b only)
Time frame: 22 days
t½ of HTX-034
Apparent terminal half-life of HTX-034 (Phase 1b only)
Time frame: 22 days
Mean AUC of Pain Scores With Activity
Mean AUC of the Numeric Rating Scale (NRS) scores with activity (windowed worst observation carried forward). Pain intensity scores were assessed using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Time frame: 7 days
Opioid Consumption
Total postoperative opioid consumption (in IV Morphine Milligram Equivalents). The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Time frame: 7 days
Proportion of Subjects Who Are Opioid-free
Proportion of subjects who took no postoperative opioids through Day 15. The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Time frame: After surgery (Day 1) through the Day 15 visit
Number of Participants With SAEs
Number and proportion of subjects with serious adverse events. The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Time frame: 42 days
| Milestone | Phase 1b: HTX-034 Low Dose | Phase 1b: HTX-034 High Dose | Phase 2: HTX-034 Low Dose | Phase 2: HTX-034 High Dose | Phases 1b/2: Bupivacaine HCl |
|---|---|---|---|---|---|
| Started | 12 | 13 | 12 | 22 | 19 |
| Completed | 11 | 13 | 11 | 21 | 17 |
| Not completed | 1 | 0 | 1 | 1 | 2 |
| Withdrew: Ineligible at day 1 | 1 | 0 | 1 | 1 | 2 |
The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
| Participants | Phases 1b/2: HTX-034 Low Dose | Phases 1b/2: HTX-034 High Dose | Phases 1b/2: Bupivacaine HCl |
|---|---|---|---|
| Incidence of TEAEs in Phases 1b/2 | 17 | 23 | 11 |
Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) of pain intensity scores with activity (windowed worst observation carried forward) through 72 hours. The NRS was an 11-point scale (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
| pain intensity score*hr | Phases 1b/2: HTX-034 Low Dose | Phases 1b/2: HTX-034 High Dose | Phases 1b/2: Bupivacaine HCl |
|---|---|---|---|
| AUC0-72 of Pain Scores | 283.50 ± 168.148 | 287.41 ± 144.247 | 363.43 ± 150.177 |
Maximum plasma concentration
| ng/mL | Phase 1b: HTX-034 Low Dose | Phase 1b: HTX-034 High Dose | Phase 2: HTX-034 Low Dose | Phase 2: HTX-034 High Dose |
|---|---|---|---|---|
| Cmax of bupivacaine | 22.0 ± 10.1 | 58.7 ± 30.6 | 27.4 ± 8.37 | 51.2 ± 23.9 |
| Cmax of aprepitant | 5.12 ± 3.64 | 12.0 ± 7.44 | 6.37 ± 2.23 | 8.09 ± 4.36 |
| Cmax of meloxicam | 11.4 ± 7.51 | 29.9 ± 17.4 | 18.1 ± 8.63 | 27.9 ± 13.8 |
Time of maximum plasma concentration
| hours (h) | Phase 1b: HTX-034 Low Dose | Phase 1b: HTX-034 High Dose | Phase 2: HTX-034 Low Dose | Phase 2: HTX-034 High Dose |
|---|---|---|---|---|
| Tmax of bupivacaine | 4.17 (2.17 to 24.23) | 7.75 (2.03 to 23.83) | 7.73 (4.02 to 18.10) | 7.75 (1.98 to 23.42) |
| Tmax of aprepitant | 60.20 (17.98 to 120.10) | 58.52 (23.60 to 164.58) | 60.13 (18.13 to 138.17) | 58.29 (17.68 to 73.27) |
| Tmax of meloxicam | 34.35 (8.12 to 70.52) | 18.05 (7.73 to 59.10) | 34.25 (11.77 to 71.70) | 21.01 (7.72 to 61.90) |
Area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration
| h*ng/mL | Phase 1b: HTX-034 Low Dose | Phase 1b: HTX-034 High Dose | Phase 2: HTX-034 Low Dose | Phase 2: HTX-034 High Dose |
|---|---|---|---|---|
| AUClast of bupivacaine | 795 ± 510 | 1970 ± 936 | 994 ± 363 | 1780 ± 966 |
| AUClast of aprepitant | 497 ± 342 | 1330 ± 813 | 604 ± 317 | 910 ± 696 |
| AUClast of meloxicam | 816 ± 611 | 2360 ± 1640 | 1170 ± 744 | 1580 ± 921 |
Area under the concentration-time curve from Time 0 extrapolated to infinity (Phase 1b only)
| h*ng/mL | Phase 1b: HTX-034 Low Dose | Phase 1b: HTX-034 High Dose |
|---|---|---|
| AUCinf of bupivacaine | 835 ± 509 | 2010 ± 920 |
| AUCinf of aprepitant | 702 ± 306 | 1340 ± 830 |
| AUCinf of meloxicam | 938 ± 607 | 2420 ± 1640 |
Apparent terminal half-life of HTX-034 (Phase 1b only)
| hours (h) | Phase 1b: HTX-034 Low Dose | Phase 1b: HTX-034 High Dose |
|---|---|---|
| t½ of bupivacaine | 15.6 ± 5.60 | 13.9 ± 4.99 |
| t½ of aprepitant | 30.6 ± 4.63 | 42.0 ± 24.4 |
| t½ of meloxicam | 25.7 ± 8.32 | 23.2 ± 4.87 |
Mean AUC of the Numeric Rating Scale (NRS) scores with activity (windowed worst observation carried forward). Pain intensity scores were assessed using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
| pain intensity score*hr | Phases 1b/2: HTX-034 Low Dose | Phases 1b/2: HTX-034 High Dose | Phases 1b/2: Bupivacaine HCl |
|---|---|---|---|
| Mean AUC of Pain Scores With Activity | 535.70 ± 322.297 | 561.93 ± 337.621 | 607.31 ± 311.639 |
Total postoperative opioid consumption (in IV Morphine Milligram Equivalents). The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
| morphine milligram equivalents (MME) | Phases 1b/2: HTX-034 Low Dose | Phases 1b/2: HTX-034 High Dose | Phases 1b/2: Bupivacaine HCl |
|---|---|---|---|
| Opioid Consumption | 9.89 ± 12.313 | 10.87 ± 17.221 | 8.88 ± 7.234 |
Proportion of subjects who took no postoperative opioids through Day 15. The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
| Participants | Phases 1b/2: HTX-034 Low Dose | Phases 1b/2: HTX-034 High Dose | Phases 1b/2: Bupivacaine HCI |
|---|---|---|---|
| Proportion of Subjects Who Are Opioid-free | 8 | 12 | 4 |
Number and proportion of subjects with serious adverse events. The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
| Participants | Phases 1b/2: HTX-034 Low Dose | Phases 1b/2: HTX-034 High Dose | Phases 1b/2: Bupivacaine HCl |
|---|---|---|---|
| Number of Participants With SAEs | 0 | 0 | 0 |
Collected over 42 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1b: HTX-034 Low Dose | 0/11 (0%) | 0/11 (0%) | 8/11 (72.7%) |
| Phase 1b: HTX-034 High Dose | 0/13 (0%) | 0/13 (0%) | 10/13 (76.9%) |
| Phase 2: HTX-034 Low Dose | 0/11 (0%) | 0/11 (0%) | 9/11 (81.8%) |
| Phase 2: HTX-034 High Dose | 0/21 (0%) | 0/21 (0%) | 13/21 (61.9%) |
| Phases 1b/2: Bupivacaine HCl | 0/17 (0%) | 0/17 (0%) | 11/17 (64.7%) |
| Event | Phase 1b: HTX-034 Low Dose | Phase 1b: HTX-034 High Dose | Phase 2: HTX-034 Low Dose | Phase 2: HTX-034 High Dose | Phases 1b/2: Bupivacaine HCl |
|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 1/11 | 5/13 | 3/11 | 1/21 | 4/17 |
| DizzinessNervous system disorders | 3/11 | 3/13 | 2/11 | 2/21 | 2/17 |
| ConstipationGastrointestinal disorders | 0/11 | 0/13 | 3/11 | 3/21 | 3/17 |
| VomitingGastrointestinal disorders | 0/11 | 3/13 | 3/11 | 0/21 | 0/17 |
| HeadacheNervous system disorders | 2/11 | 3/13 | 1/11 | 1/21 | 1/17 |
| Vessel puncture site haematomaGeneral disorders | 2/11 | 0/13 | 0/11 | 0/21 | 0/17 |
| SomnolenceNervous system disorders | 1/11 | 2/13 | 1/11 | 1/21 | 2/17 |
| Muscle twitchingMusculoskeletal and connective tissue disorders | 0/11 | 2/13 | 0/11 | 0/21 | 2/17 |
| BradycardiaCardiac disorders | 0/11 | 0/13 | 1/11 | 3/21 | 1/17 |
| HypotensionVascular disorders | 0/11 | 0/13 | 1/11 | 2/21 | 1/17 |
Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
| Age, Categorical(Participants) | Phase 1b: HTX-034 Low Dose | Phase 1b: HTX-034 High Dose | Phase 2: HTX-034 Low Dose | Phase 2: HTX-034 High Dose | Phases 1b/2: Bupivacaine HCl | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 10 | 11 | 19 | 17 | 68 |
| >=65 years | 0 | 3 | 0 | 2 | 0 | 5 |
| Age, Continuous(years) | Phase 1b: HTX-034 Low Dose | Phase 1b: HTX-034 High Dose | Phase 2: HTX-034 Low Dose | Phase 2: HTX-034 High Dose | Phases 1b/2: Bupivacaine HCl | Total |
|---|---|---|---|---|---|---|
| Mean | 48.6 ± 14.35 | 53.1 ± 12.89 | 51.6 ± 11.25 | 47.0 ± 12.50 | 53.3 ± 6.44 | 50.5 ± 11.57 |
| Sex: Female, Male(Participants) | Phase 1b: HTX-034 Low Dose | Phase 1b: HTX-034 High Dose | Phase 2: HTX-034 Low Dose | Phase 2: HTX-034 High Dose | Phases 1b/2: Bupivacaine HCl | Total |
|---|---|---|---|---|---|---|
| Female | 8 | 13 | 11 | 19 | 13 | 64 |
| Male | 3 | 0 | 0 | 2 | 4 | 9 |
| Race (NIH/OMB)(Participants) | Phase 1b: HTX-034 Low Dose | Phase 1b: HTX-034 High Dose | Phase 2: HTX-034 Low Dose | Phase 2: HTX-034 High Dose | Phases 1b/2: Bupivacaine HCl | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 4 | 3 | 2 | 9 |
| White | 11 | 12 | 7 | 16 | 14 | 60 |
| More than one race | 0 | 1 | 0 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Phase 1b: HTX-034 Low Dose | Phase 1b: HTX-034 High Dose | Phase 2: HTX-034 Low Dose | Phase 2: HTX-034 High Dose | Phases 1b/2: Bupivacaine HCl | Total |
|---|---|---|---|---|---|---|
| United States | 11 | 13 | 11 | 21 | 17 | 73 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from May 2020 to primary completion in Jul 2021, 14 months.
Results were first posted in Jun 2026, 4 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.