CompletedNCT02762929Updated Feb 23, 2026Results posted

Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy

A Phase 2 interventional study of HTX-011A and Saline Placebo in Postoperative Pain and Bunions, sponsored by Heron Therapeutics. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-23.

Sponsored by Heron Therapeutics · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 430
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy

Read the detailed description

This study includes multiple formulations for formulation selection of the fixed-combination product and for the factorial design assessment of the contribution of each component. HTX-011A is the second formulation studied (HTX-011-49). HTX-011B is the final formulation studied (HTX-011-56), which was also included in subsequent Phase 2b and Phase 3 studies. For the factorial design assessment, HTX-002, a bupivacaine-only formulation in the same HTX-011 proprietary polymer, and HTX-009, a meloxicam-only formulation in the same HTX-011 proprietary polymer, were evaluated.

Conditions studied

Postoperative Pain
Bunions

Browse trials for

Keywords

Analgesia
Bunionectomy

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's enrollment of 430 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

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.

Browse Heron Therapeutics studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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.

Inclusion criteria

Be male or female 18 years of age or older
Female subjects are eligible only if all of the following apply:
1. Not pregnant (female subject of child bearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test before surgery)
2. Not lactating
3. Not planning to become pregnant while participating in the study
4. Be surgically sterile; or be at least two years ; or have a monogamous partner who is surgically sterile; or be practicing double-barrier ; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening visits and commits to the use of an acceptable form of birth control for the duration of the study and for 30 days from completion of the study
Male subjects must be surgically sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study until at least 1 week after the administration of study medication
Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia
Subject has not had a contralateral bunionectomy in the non-study foot in the past 3 months
Have the ability and be willing to comply with the study procedures.
Must be able to understand study procedures and give for the conduct for all study procedures, using an IRB approved consent form

Exclusion criteria

Exclusion Criteria:

Unwilling to sign or not willing or able to complete all study procedures
Have a or be allergic to any medication to be used during the trial period
Have cardiac abnormalities that, in the opinion of the investigator, would pose a health risk to the subject
Have (ASA) Physical Status classification system category ≥4
Have clinically significant renal or hepatic abnormalities: for example, or ALT > 3x , creatinine > 2x ULN
Have another pre-existing painful condition that may confound pain assessments
Have another surgery planned within 30 days of procedure
Have a known or suspected history of alcohol or drug abuse, or a positive drug screen
Currently taking analgesics for a chronically painful condition, or has taken long acting opioids within 3 days of surgery, or taken any opioids within 24 hours of scheduled surgery for this study
Subjects with documented sleep apnea or are on home continuous positive airway pressure (CPAP)
Subjects who are receiving oxygen therapy at the time of screening
Have participated in a clinical trial within 30 days of planned surgery

Terms in these criteria, in plain language(8)

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.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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.

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.

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.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 430 participants (actual)

Study arms

Experimental
HTX-011A: 200 mg
HTX-011A (bupivacaine/meloxicam), 200 mg/6 mg via injection.
Drug: HTX-011A
Experimental
HTX-011B: 30 mg
HTX 011B (bupivacaine/meloxicam), 30 mg/0.9 mg via injection.
Drug: HTX-011B
Experimental
HTX-011B : 60 mg
HTX-011B (bupivacaine/meloxicam) 60 mg/1.8 mg via injection or instillation.
Drug: HTX-011B
Experimental
HTX-011B: 120 mg
HTX- 011B (bupivacaine/meloxicam), 120 mg/3.6 mg via injection or instillation.
Drug: HTX-011B
Experimental
HTX-011B: 200 mg
HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection.
Drug: HTX-011B
Active comparator
Bupivacaine HCI
Bupivacaine HCI, 50 mg via injection.
Drug: Bupivacaine HCl
Active comparator
Saline Placebo
Saline placebo via injection.
Biological: Saline Placebo
Experimental
HTX-002, 60 mg
HTX- 002, 60 mg via injection.
Drug: HTX-002
Experimental
HTX-002, 120 mg
HTX-002, 120 mg via injection.
Drug: HTX-002
Experimental
HTX-002, 200 mg
HTX-002, 200 mg via injection.
Drug: HTX-002
Experimental
HTX-009
HTX-009, 3.6 mg via injection.
Drug: HTX-009

Interventions

DrugHTX-011A
HTX-011A (bupivacaine/meloxicam), via injection.
BiologicalSaline Placebo
Saline placebo via injection.
DrugHTX-011B
HTX-011B (bupivacaine/meloxicam), via injection or instillation.
DrugHTX-002
HTX-002, via injection.
DrugBupivacaine HCl
Bupivacaine HCI, via injection.
DrugHTX-009
HTX-009, via injection.

What researchers measure

Primary outcomes

Mean Summed Pain Intensity (SPI) Score Over 24 Hours
The SPI is derived by summing the pain intensity score weighted by the scheduled time duration. SPI0-24 will be calculated by summing the Pain intensity (PI) score at the relevant time points weighted by the scheduled time duration since the prior PI assessment as follows: SPI0-24= PI1+PI2+2\*PI4+2\*PI6+2\*PI8+2\*PI10+2\*PI12+2\*PI14+4\*PI18+6\*PI24. Min = 0 (if PI=0 at every time) and Max = 240 (if PI=10 at every time).
Time frame: 0-24 hours

Results

Posted Oct 4, 2023

Participant flow

Participant flow — Overall Study
Milestone	HTX-011A	HTX-011B	Bupivacaine HCI	Saline Placebo	HTX-002	HTX-009
Started	32	175	25	104	64	30
Completed	31	172	25	101	64	30
Not completed	1	3	0	3	0	0
Withdrew: Adverse event	0	0	0	1	0	0
Withdrew: Lost to follow-up	1	2	0	1	0	0
Withdrew: Withdrawal by subject	0	1	0	0	0	0
Withdrew: Exclusionary medication disclosed late	0	0	0	1	0	0

Outcome measures

PrimaryMean Summed Pain Intensity (SPI) Score Over 24 Hours

The SPI is derived by summing the pain intensity score weighted by the scheduled time duration. SPI0-24 will be calculated by summing the Pain intensity (PI) score at the relevant time points weighted by the scheduled time duration since the prior PI assessment as follows: SPI0-24= PI1+PI2+2\*PI4+2\*PI6+2\*PI8+2\*PI10+2\*PI12+2\*PI14+4\*PI18+6\*PI24. Min = 0 (if PI=0 at every time) and Max = 240 (if PI=10 at every time).

Time frame:: 0-24 hours
Reported as:: Mean · Units on a scale

Mean Summed Pain Intensity (SPI) Score Over 24 Hours
Units on a scale	HTX-011A: 200 mg	HTX-011B: 30 mg	HTX-011B: 60 mg	HTX-011B: 120 mg	HTX-011B: 200 mg	Bupivacaine HCI: 50 mg	Saline Placebo	HTX-002, 60 mg	HTX-002, 120 mg	HTX-002, 200 mg	HTX-009
Mean Summed Pain Intensity (SPI) Score Over 24 Hours	69.16 ± 43.092	96.83 ± 50.151	83.38 ± 46.226	85.70 ± 40.716	49.23 ± 40.781	118.16 ± 50.634	126.46 ± 47.785	112.00 ± 37.239	129.97 ± 45.897	107.82 ± 60.547	127.83 ± 49.196

Adverse events

Collected over 28 Days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
HTX-011A	0/33 (0%)	1/33 (3%)	20/33 (60.6%)
HTX-011B	0/174 (0%)	1/174 (0.6%)	113/174 (64.9%)
Bupivacaine HCI	0/25 (0%)	0/25 (0%)	19/25 (76%)
Saline Placebo	0/104 (0%)	0/104 (0%)	70/104 (67.3%)
HTX-002	0/64 (0%)	0/64 (0%)	43/64 (67.2%)
HTX-009	0/30 (0%)	2/30 (6.7%)	20/30 (66.7%)

Most frequent serious events

Most frequent serious events
Event	HTX-011A	HTX-011B	Bupivacaine HCI	Saline Placebo	HTX-002	HTX-009
Impaired healingGeneral disorders	0/33	1/174	0/25	0/104	0/64	1/30
InflammationGeneral disorders	0/33	0/174	0/25	0/104	0/64	1/30
Post procedural cellulitisInfections and infestations	1/33	0/174	0/25	0/104	0/64	0/30
Postoperative wound infectionInfections and infestations	1/33	0/174	0/25	0/104	0/64	0/30

Most frequent other events

Showing 10 of 19

Most frequent other events
Event	HTX-011A	HTX-011B	Bupivacaine HCI	Saline Placebo	HTX-002	HTX-009
NauseaGastrointestinal disorders	8/33	73/174	11/25	44/104	28/64	13/30
VomitingGastrointestinal disorders	5/33	28/174	5/25	27/104	12/64	4/30
HeadacheNervous system disorders	8/33	28/174	5/25	19/104	12/64	3/30
ConstipationGastrointestinal disorders	2/33	17/174	1/25	20/104	8/64	4/30
PruritusSkin and subcutaneous tissue disorders	3/33	8/174	4/25	7/104	6/64	0/30
DizzinessNervous system disorders	5/33	10/174	2/25	8/104	4/64	3/30
ErythemaSkin and subcutaneous tissue disorders	3/33	18/174	2/25	3/104	9/64	2/30
Oedema peripheralGeneral disorders	1/33	5/174	1/25	0/104	9/64	0/30
Wound dehiscenceInjury, poisoning and procedural complications	4/33	3/174	0/25	1/104	0/64	0/30
EscharInjury, poisoning and procedural complications	4/33	1/174	0/25	0/104	0/64	1/30

Baseline characteristics

Study HTX-011-208 included multiple study parts, various study drugs, formulations, and administration techniques. It was pre-specified in the SAP to pool different doses of the same study drug within study parts for Participant Flow, Baseline Characteristics, and AEs. We pooled different doses of the same study drug within study parts for Participant Flow, Baseline Characteristics, and AEs. However for Outcome Measures, different doses of study drugs were presented separately.

Age, Categorical
Age, Categorical(Participants)	HTX-011A	HTX-011B	Bupivacaine HCI	Saline Placebo	HTX-002	HTX-009	Total
<=18 years	0	0	0	0	0	0	0
Between 18 and 65 years	28	149	23	86	56	26	368
>=65 years	5	25	2	18	8	4	62

Age, Continuous
Age, Continuous(Years)	HTX-011A	HTX-011B	Bupivacaine HCI	Saline Placebo	HTX-002	HTX-009	Total
Mean	49.7 ± 13.86	50.4 ± 13.79	52.7 ± 11.81	50.0 ± 13.46	50.2 ± 12.51	49.9 ± 13.41	50.3 ± 13.34

Sex: Female, Male
Sex: Female, Male(Participants)	HTX-011A	HTX-011B	Bupivacaine HCI	Saline Placebo	HTX-002	HTX-009	Total
Female	27	148	22	91	57	27	372
Male	6	26	3	13	7	3	58

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	HTX-011A	HTX-011B	Bupivacaine HCI	Saline Placebo	HTX-002	HTX-009	Total
Hispanic or Latino	9	50	5	28	26	10	128
Not Hispanic or Latino	24	124	20	76	38	20	302
Unknown or Not Reported	0	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	HTX-011A	HTX-011B	Bupivacaine HCI	Saline Placebo	HTX-002	HTX-009	Total
United States	33	174	25	104	64	30	430

Study locations

5 sites

Anaheim, California 92801, United States
Bakersfield, California 93311, United States
Pasadena, Maryland 21122, United States
Houston, Texas 77027, United States
San Antonio, Texas 78229, United States

References and documents

Publications

Ottoboni T, Quart B, Pawasauskas J, Dasta JF, Pollak RA, Viscusi ER. Mechanism of action of HTX-011: a novel, extended-release, dual-acting local anesthetic formulation for postoperative pain. Reg Anesth Pain Med. 2019 Dec 16:rapm-2019-100714. doi: 10.1136/rapm-2019-100714. Online ahead of print. PubMed 31843865 ↗

Study documents

Study protocol ↗ · Jan 23, 2017
Statistical analysis plan ↗ · Mar 1, 2017

PDFs hosted by the registry, ClinicalTrials.gov.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02762929
Lead sponsor: Heron Therapeutics
Responsible party: Sponsor
First posted: May 5, 2016
Start date: May 2016
Primary completion: Feb 2017
Completion: Mar 2017
Results posted: Oct 4, 2023
Last update: Feb 23, 2026

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions 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.

Studies of the drugs tested here: HTX-011A · HTX-011B · HTX-002

Other studies in this condition

Pain, Postoperative →

Other studies from this sponsor

Heron Therapeutics →

Start the discussion