Trial · NCT03295721
Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
NCT03295721, Phase 3, Completed, Heron Therapeutics; results first posted 2021-10-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bunionectomy Study for Postoperative Analgesia (EPOCH 1). Trials, record NCT03295721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03295721
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
- NCT number
- NCT03295721
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 412 participants, actual
- Lead sponsor
- Heron Therapeutics
- Conditions
- Postoperative Pain
- Interventions
- HTX-011, Saline Placebo, Bupivacaine HCl, Luer-lock applicator, Vial access device
- First posted
- 2017-09-28
- Last updated
- 2026-03-02
- Results first posted
- 2021-10-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Saline Placebo. | 72 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 AUC0-72 is 0-720. The prescribed activity for NRS-A is sitting with the plantar surface of the ball of the surgically attended foot touching the floor (no weight bearing). |
| Secondary | Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Bupivacaine HCl. | 72 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 AUC0-72 is 0-720. The prescribed activity for NRS-A is sitting with the plantar surface of the ball of the surgically attended foot touching the floor (no weight bearing). |
| Secondary | Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo. | 72 hours | |
| Secondary | Percentage of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl. | 72 hours | |
| Secondary | Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl. | 72 hours |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Saline Placebo. | 72 hours | ITT Population | pain intensity score*hr | MEAN |
| SECONDARY | Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Bupivacaine HCl. | 72 hours | ITT Population | pain intensity score*hr | MEAN |
| SECONDARY | Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo. | 72 hours | ITT Population | IV milligram morphine equivalent (MME) | MEAN |
| SECONDARY | Percentage of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl. | 72 hours | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl. | 72 hours | ITT Population | IV milligram morphine equivalent (MME) | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Saline Placebo. | Treatment Group 1: HTX-011 | 323.29 | Standard Deviation 182.641 | pain intensity score*hr | |
| Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Saline Placebo. | Treatment Group 2: Saline Placebo | 445.34 | Standard Deviation 155.792 | pain intensity score*hr | |
| Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Bupivacaine HCl. | Treatment Group 1: HTX-011 | 323.29 | Standard Deviation 182.641 | pain intensity score*hr | |
| Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Bupivacaine HCl. | Treatment Group 3: Bupivacaine HCI | 393.45 | Standard Deviation 153.756 | pain intensity score*hr | |
| Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo. | Treatment Group 1: HTX-011 | 18.80 | Standard Deviation 19.801 | IV milligram morphine equivalent (MME) | |
| Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo. | Treatment Group 2: Saline Placebo | 30.06 | Standard Deviation 21.016 | IV milligram morphine equivalent (MME) | |
| Percentage of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl. | Treatment Group 1: HTX-011 | 45 | Participants | ||
| Percentage of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl. | Treatment Group 3: Bupivacaine HCI | 17 | Participants | ||
| Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl. | Treatment Group 1: HTX-011 | 18.80 | Standard Deviation 19.801 | IV milligram morphine equivalent (MME) | |
| Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl. | Treatment Group 3: Bupivacaine HCl | 25.09 | Standard Deviation 21.553 | IV milligram morphine equivalent (MME) |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Group 1: HTX-011 | 157 | |
| Overall Study | STARTED | Treatment Group 2: Saline Placebo | 100 | |
| Overall Study | STARTED | Treatment Group 3: Bupivacaine HCI | 155 | |
| Overall Study | COMPLETED | Treatment Group 1: HTX-011 | 154 | |
| Overall Study | COMPLETED | Treatment Group 2: Saline Placebo | 99 | |
| Overall Study | COMPLETED | Treatment Group 3: Bupivacaine HCI | 152 | |
| Overall Study | NOT COMPLETED | Treatment Group 1: HTX-011 | 3 | |
| Overall Study | NOT COMPLETED | Treatment Group 2: Saline Placebo | 1 | |
| Overall Study | NOT COMPLETED | Treatment Group 3: Bupivacaine HCI | 3 |
Source ClinicalTrials.gov
Adverse events72
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Treatment Group 1: HTX-011 | 59 | 157 | |
| other | Nausea | Gastrointestinal disorders | Treatment Group 2: Saline Placebo | 44 | 101 | |
| other | Nausea | Gastrointestinal disorders | Treatment Group 3: Bupivacaine HCl | 70 | 154 | |
| other | Dizziness | Nervous system disorders | Treatment Group 1: HTX-011 | 34 | 157 | |
| other | Dizziness | Nervous system disorders | Treatment Group 2: Saline Placebo | 18 | 101 | |
| other | Dizziness | Nervous system disorders | Treatment Group 3: Bupivacaine HCl | 36 | 154 | |
| other | Incision site oedema | Injury, poisoning and procedural complications | Treatment Group 1: HTX-011 | 27 | 157 | |
| other | Incision site oedema | Injury, poisoning and procedural complications | Treatment Group 2: Saline Placebo | 13 | 101 | |
| other | Incision site oedema | Injury, poisoning and procedural complications | Treatment Group 3: Bupivacaine HCl | 22 | 154 | |
| other | Vomiting | Gastrointestinal disorders | Treatment Group 1: HTX-011 | 23 | 157 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Group 1: HTX-011 | 0 | 157 |
| Total, all-cause mortality | Treatment Group 2: Saline Placebo | 0 | 101 |
| Total, all-cause mortality | Treatment Group 3: Bupivacaine HCl | 1 | 154 |
| Total, other adverse events | Treatment Group 1: HTX-011 | 111 | 157 |
| Total, other adverse events | Treatment Group 2: Saline Placebo | 70 | 101 |
| Total, other adverse events | Treatment Group 3: Bupivacaine HCl | 112 | 154 |
| Total, serious adverse events | Treatment Group 1: HTX-011 | 3 | 157 |
| Total, serious adverse events | Treatment Group 2: Saline Placebo | 1 | 101 |
| Total, serious adverse events | Treatment Group 3: Bupivacaine HCl | 3 | 154 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Treatment Group 1: HTX-011 vs Treatment Group 3: Bupivacaine HCI: Percentage of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl. |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03295721
GET https://conductscience.org/api/trials/v1/NCT03295721/events?page=2