Phase 2 Herniorrhaphy Study for Opioid Elimination

Phase 2

Completed

Conditions: Postoperative Pain

Interventions: Drug: HTX-011
Device: Luer lock applicator
Device: Vial access device
Drug: Ibuprofen
Drug: Acetaminophen
Drug: Ketorolac

Registration Number: NCT03695367

Lead Sponsor: Heron Therapeutics

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 63

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1: HTX-011 + MMA Regimen	HTX-011	HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
Cohort 1: HTX-011 + MMA Regimen	Luer lock applicator	HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
Cohort 1: HTX-011 + MMA Regimen	Vial access device	HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
Cohort 2: HTX-011 + MMA Regimen + Ketorolac	Luer lock applicator	HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
Cohort 2: HTX-011 + MMA Regimen + Ketorolac	Vial access device	HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
Cohort 2: HTX-011 + MMA Regimen + Ketorolac	HTX-011	HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
Cohort 1: HTX-011 + MMA Regimen	Ibuprofen	HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
Cohort 2: HTX-011 + MMA Regimen + Ketorolac	Ketorolac	HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
Cohort 1: HTX-011 + MMA Regimen	Acetaminophen	HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
Cohort 2: HTX-011 + MMA Regimen + Ketorolac	Ibuprofen	HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
Cohort 2: HTX-011 + MMA Regimen + Ketorolac	Acetaminophen	HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Receiving no Opioid Rescue	72 hours

Secondary Outcome Measures

Name	Time	Method
Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [IV MME])	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
Percentge of Subjects Receiving no Opioid Rescue	Day 28

Trial Locations

Locations (3): Anaheim Clinical Trials, LLC
🇺🇸
Anaheim, California, United States
Lotus Clinical Research, LLC
🇺🇸
Pasadena, California, United States
JBR Clinical Research
🇺🇸
Salt Lake City, Utah, United States