A Phase 3 interventional study of HTX-011 and Luer lock applicator in Analgesia, sponsored by Heron Therapeutics. Completed at 30 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Heron Therapeutics · Phase 3, Interventional, and Treatment
This is a Phase 3b, open-label study to assess postoperative opioid use in subjects undergoing unilateral open inguinal herniorrhaphy with intraoperative administration of HTX-011 and a postoperative non-opioid multimodal analgesic (MMA) regimen. The study will be conducted in 2 sequential parts: Part 1 is randomized and Part 2 is Investigator's preference for MMA regimen.
543 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.
This study's enrollment of 209 is above the median of 90 across 395 interventional studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal 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:
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.
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.
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake.
Drug: HTX-011 · Device: Luer lock applicator · Drug: Ibuprofen · Drug: Acetaminophen
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake.
Drug: HTX-011 · Device: Luer lock applicator · Drug: Ibuprofen · Drug: Acetaminophen
Drug pages: Bupivacaine · Meloxicam
300 mg bupivacaine/9 mg meloxicam
Also known as: ZYNRELEF
Applicator for instillation
600 mg
1 g
Proportion of Subjects Who do Not Receive an Opioid Prescription Through the Day 15 Visit
Time frame: Through Day 15
Proportion of Subjects Who do Not Receive an Opioid Prescription at Discharge
Proportion of subjects who do not receive an opioid prescription at discharge (between 2 and 3 hours after surgery on average).
Time frame: At discharge
Proportion of Subjects Who do Not Receive a Postdischarge Opioid Prescription, Through the Day 15 Visit.
Time frame: Postdischarge through Day 15
Pain Intensity Scores at the Time of Discharge
Pain intensity scores were assessed at discharge (between 2 and 3 hours after surgery on average) using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded with activity (NRS-A), sitting up from a resting position.
Time frame: At discharge
Number of Oxycodone Pills Taken Between Discharge and the Day 15 Visit
Time frame: Postdischarge through Day 15
Mean TSQM-9 Scores
The TSQM-9 contains 9 items which make up the Effectiveness, Convenience, and Global Satisfaction domains; each domain includes 3 items. Scores for each domain were computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, with higher scores indicating higher satisfaction.
Time frame: Day 15 plus or minus 2 days
| Milestone | HTX-011 + Alternating MMA Regimen | HTX-011 + Concurrent MMA Regimen |
|---|---|---|
| Started | 102 | 107 |
| Completed | 100 | 107 |
| Not completed | 2 | 0 |
| Participants | HTX-011 + Alternating MMA Regimen | HTX-011 + Concurrent MMA Regimen |
|---|---|---|
| Proportion of Subjects Who do Not Receive an Opioid Prescription Through the Day 15 Visit | 95 | 97 |
Proportion of subjects who do not receive an opioid prescription at discharge (between 2 and 3 hours after surgery on average).
| Participants | HTX-011 + Alternating MMA Regimen | HTX-011 + Concurrent MMA Regimen |
|---|---|---|
| Proportion of Subjects Who do Not Receive an Opioid Prescription at Discharge | 95 | 98 |
| Participants | HTX-011 + Alternating MMA Regimen | HTX-011 + Concurrent MMA Regimen |
|---|---|---|
| Proportion of Subjects Who do Not Receive a Postdischarge Opioid Prescription, Through the Day 15 Visit. | 101 | 105 |
Pain intensity scores were assessed at discharge (between 2 and 3 hours after surgery on average) using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded with activity (NRS-A), sitting up from a resting position.
| score on a scale | HTX-011 + Alternating MMA Regimen | HTX-011 + Concurrent MMA Regimen |
|---|---|---|
| NRS-R | 2.3 ± 1.51 | 2.6 ± 1.89 |
| NRS-A | 2.7 ± 1.84 | 3.2 ± 2.06 |
| Number of oxycodone 5 mg pills | HTX-011 + Alternating MMA Regimen | HTX-011 +Concurrent MMA Regimen |
|---|---|---|
| Number of Oxycodone Pills Taken Between Discharge and the Day 15 Visit | 11.5 (10 to 13) | 12.7 (5 to 22) |
The TSQM-9 contains 9 items which make up the Effectiveness, Convenience, and Global Satisfaction domains; each domain includes 3 items. Scores for each domain were computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, with higher scores indicating higher satisfaction.
| score on a scale | HTX-011 + Alternating MMA Regimen | HTX-011 + Concurrent MMA Regimen |
|---|---|---|
| Effectiveness Domain | 86.8 ± 15.89 | 84.1 ± 19.33 |
| Convenience Domain | 89.3 ± 12.35 | 88.7 ± 12.94 |
| Global Satisfaction Domain | 87.4 ± 14.03 | 85.4 ± 16.40 |
Collected over 29 Days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HTX-011 + Alternating MMA Regimen | 0/102 (0%) | 1/102 (1%) | 7/102 (6.9%) |
| HTX-011 + Concurrent MMA Regimen | 0/107 (0%) | 0/107 (0%) | 14/107 (13.1%) |
| Event | HTX-011 + Alternating MMA Regimen | HTX-011 + Concurrent MMA Regimen |
|---|---|---|
| Peptic Ulcer HaemorrhageGastrointestinal disorders | 1/102 | 0/107 |
| Event | HTX-011 + Alternating MMA Regimen | HTX-011 + Concurrent MMA Regimen |
|---|---|---|
| NauseaGastrointestinal disorders | 5/102 | 8/107 |
| ConstipationGastrointestinal disorders | 2/102 | 6/107 |
| Age, Categorical(Participants) | HTX-011 + Alternating MMA Regimen | HTX-011 + Concurrent MMA Regimen | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 76 | 76 | 152 |
| >=65 years | 26 | 31 | 57 |
| Age, Continuous(years) | HTX-011 + Alternating MMA Regimen | HTX-011 + Concurrent MMA Regimen | Total |
|---|---|---|---|
| Mean | 55.1 ± 14.71 | 55.6 ± 14.35 | 55.4 ± 14.47 |
| Sex: Female, Male(Participants) | HTX-011 + Alternating MMA Regimen | HTX-011 + Concurrent MMA Regimen | Total |
|---|---|---|---|
| Female | 3 | 1 | 4 |
| Male | 99 | 106 | 205 |
| Ethnicity (NIH/OMB)(Participants) | HTX-011 + Alternating MMA Regimen | HTX-011 + Concurrent MMA Regimen | Total |
|---|---|---|---|
| Hispanic or Latino | 32 | 21 | 53 |
| Not Hispanic or Latino | 70 | 86 | 156 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | HTX-011 + Alternating MMA Regimen | HTX-011 + Concurrent MMA Regimen | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 11 | 16 |
| White | 95 | 91 | 186 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Region of Enrollment(participants) | HTX-011 + Alternating MMA Regimen | HTX-011 + Concurrent MMA Regimen | Total |
|---|---|---|---|
| United States | 102 | 107 | 209 |
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Studies of the drugs tested here: Bupivacaine · Meloxicam