Trial · NCT03237481

Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)

NCT03237481, Phase 3, Completed, Heron Therapeutics; results first posted 2021-10-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2). Trials, record NCT03237481. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03237481

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)
NCT number: NCT03237481
Status: Completed
Phases: Phase 3
Enrollment: 418 participants, actual
Lead sponsor: Heron Therapeutics
Conditions: Postoperative Pain
Interventions: HTX-011, Bupivacaine HCl, Saline placebo, Luer-lock applicator, Vial access device
First posted: 2017-08-02
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 up from a resting position.
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 up from a resting position.
Secondary	Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo.	72 hours
Secondary	Percetange 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	Percetange 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	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	269.39	Standard Deviation 173.719	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 3: Saline Placebo	350.82	Standard Deviation 171.224	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	269.39	Standard Deviation 173.719	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 2: Bupivacaine HCI	341.88	Standard Deviation 158.303	pain intensity score*hr
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo.	Treatment Group 1: HTX-011	10.85	Standard Deviation 17.062	IV milligram morphine equivalent (MME)
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo.	Treatment Group 3: Saline Placebo	17.53	Standard Deviation 18.908	IV milligram morphine equivalent (MME)
Percetange of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl.	Treatment Group 1: HTX-011	84		Participants
Percetange of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl.	Treatment Group 2: Bupivacaine HCI	69		Participants
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl.	Treatment Group 1: HTX-011	10.85	Standard Deviation 17.062	IV milligram morphine equivalent (MME)
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl.	Treatment Group 2: Bupivacaine HCI	14.51	Standard Deviation 18.185	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
Overall Study	STARTED	Treatment Group 1: HTX-011	164
Overall Study	STARTED	Treatment Group 2: Bupivacaine HCI	172
Overall Study	STARTED	Treatment Group 3: Saline Placebo	82
Overall Study	COMPLETED	Treatment Group 1: HTX-011	159
Overall Study	COMPLETED	Treatment Group 2: Bupivacaine HCI	170
Overall Study	COMPLETED	Treatment Group 3: Saline Placebo	81
Overall Study	NOT COMPLETED	Treatment Group 1: HTX-011	5
Overall Study	NOT COMPLETED	Treatment Group 2: Bupivacaine HCI	2
Overall Study	NOT COMPLETED	Treatment Group 3: Saline Placebo	1

Source ClinicalTrials.gov

Adverse events51

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
other	Nausea	Gastrointestinal disorders	Treatment Group 1: HTX-011	30	163
other	Nausea	Gastrointestinal disorders	Treatment Group 2: Bupivacaine HCI	37	173
other	Nausea	Gastrointestinal disorders	Treatment Group 3: Saline Placebo	28	82
other	Constipation	Gastrointestinal disorders	Treatment Group 1: HTX-011	28	163
other	Constipation	Gastrointestinal disorders	Treatment Group 2: Bupivacaine HCI	41	173
other	Constipation	Gastrointestinal disorders	Treatment Group 3: Saline Placebo	15	82
other	Dizziness	Nervous system disorders	Treatment Group 1: HTX-011	24	163
other	Dizziness	Nervous system disorders	Treatment Group 2: Bupivacaine HCI	42	173
other	Dizziness	Nervous system disorders	Treatment Group 3: Saline Placebo	13	82
other	Headache	Nervous system disorders	Treatment Group 1: HTX-011	21	163

1 to 10 of 51Source ClinicalTrials.gov

See all 51 adverse events

Adverse 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	163
Total, all-cause mortality	Treatment Group 2: Bupivacaine HCI	0	173
Total, all-cause mortality	Treatment Group 3: Saline Placebo	0	82
Total, other adverse events	Treatment Group 1: HTX-011	84	163
Total, other adverse events	Treatment Group 2: Bupivacaine HCI	104	173
Total, other adverse events	Treatment Group 3: Saline Placebo	49	82
Total, serious adverse events	Treatment Group 1: HTX-011	2	163
Total, serious adverse events	Treatment Group 2: Bupivacaine HCI	1	173
Total, serious adverse events	Treatment Group 3: Saline Placebo	1	82

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34284613	DERIVED	PubMed
34318438	DERIVED	PubMed

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 2: Bupivacaine HCI: Percetange 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03237481

GET https://conductscience.org/api/trials/v1/NCT03237481/events?page=2

API reference For AI assistants