Phase 2 Herniorrhaphy Study for Opioid Elimination

A Phase 2, Open-Label Study of HTX 011 in a Multimodal Analgesic Regimen for Decreased Opioid Use Following Unilateral Open Inguinal Herniorrhaphy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03695367

Enrollment

Registered

2018-10-04

Start date

2018-10-01

Completion date

2018-12-15

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

inguinal hernia, hernia, hernia surgery, postoperative pain, herniorrhaphy

Brief summary

This is a Phase 2, open-label study in subjects undergoing unilateral open inguinal herniorrhaphy.

Interventions

DRUGHTX-011

HTX-011 (bupivacaine/meloxicam), 300 mg/ 9 mg via instillation.

DEVICELuer lock applicator

Applicator for instillation.

DEVICEVial access device

Device for withdrawal of drug product.

DRUGIbuprofen

Ibuprofen, 600 mg.

DRUGAcetaminophen

Acetaminophen, 1 g.

DRUGKetorolac

Intraoperative IV ketorolac.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia. * Has an American Society of Anesthesiologists Physical Status of I, II, or III. * Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.

Exclusion criteria

* Had any prior inguinal hernia repair except as a child (less than 6 years of age). * Has a planned concurrent surgical procedure (eg, bilateral herniorrhaphy). * Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain. * Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications. * Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. * Has taken any NSAIDs within least 10 days prior to the scheduled surgery. * Has taken long-acting opioids within 3 days prior to the scheduled surgery. * Has taken any opioids within 24 hours prior to the scheduled surgery. * Has been administered bupivacaine within 5 days prior to the scheduled surgery. * Has been administered any local anesthetic within 72 hours prior to the scheduled surgery. * Has initiated treatment with study medications within 1 month prior to study drug administration that can impact pain control. * Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug. * Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments. * As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV). * Has uncontrolled anxiety, psychiatric, or neurological disorder. * Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. * Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study at the discretion of the Sponsor. Subjects taking any marijuana (medical or recreational) are not allowed to participate in the study. * Previously participated in an HTX-011 study. * Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives. * Has undergone 3 or more surgeries within 12 months. * Has a body mass index (BMI) \>39 kg/m2.

Design outcomes

Primary

Measure	Time frame
Percentage of Subjects Receiving no Opioid Rescue	72 hours

Secondary

Measure	Time frame
Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [IV MME])	72 hours
Percentge of Subjects Receiving no Opioid Rescue	0-24 hours, 24-48 hours, 24-72 hours, 48-72 hours
Percentge of Subjects in Severe Pain With Numeric Rating Scale (NRS-R; Windowed Worst Observation Carried Forward) of Pain Intensity Scores >7 on a Scale of 0-10 at Any Point. NRS-R for Pain Where 0 Equals no Pain and 10 Equals Worst Pain Imaginable.	72 hours

Countries

United States

Contacts

STUDY_CHAIRNeil Singla, MD

Lotus Clinical Research, LLC

Participant flow

Participants by arm

Arm	Count
Cohort 1: HTX-011 + MMA Regimen HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.	33
Cohort 2: HTX-011 + MMA Regimen + Ketorolac HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.	30
Total	63

Baseline characteristics

Characteristic	Cohort 1: HTX-011 + MMA Regimen	Cohort 2: HTX-011 + MMA Regimen + Ketorolac	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	3 Participants	4 Participants	7 Participants
Age, Categorical Between 18 and 65 years	30 Participants	26 Participants	56 Participants
Age, Continuous	50.9 years STANDARD_DEVIATION 13.52	46.1 years STANDARD_DEVIATION 14.99	48.7 years STANDARD_DEVIATION 14.33
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants	9 Participants	23 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants	21 Participants	40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	4 Participants	5 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	30 Participants	26 Participants	56 Participants
Region of Enrollment United States	33 participants	30 participants	63 participants
Sex: Female, Male Female	0 Participants	4 Participants	4 Participants
Sex: Female, Male Male	33 Participants	26 Participants	59 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 33	0 / 30
other Total, other adverse events	5 / 33	7 / 30
serious Total, serious adverse events	0 / 33	0 / 30

Arm	Measure	Value (MEAN)	Dispersion
Cohort 1: HTX-011 + MMA Regimen	Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [IV MME])	0.59 MME, morphine milligram equivalents	Standard Deviation 2.141
Cohort 2: HTX-011 + MMA Regimen + Ketorolac	Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [IV MME])	1.32 MME, morphine milligram equivalents	Standard Deviation 4.199

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026