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

Heron Therapeutics5 个研究点分布在 1 个国家目标入组 63 人开始时间: 2018年10月1日最近更新: 2026年3月2日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Heron Therapeutics
入组人数: 63
试验地点: 5
主要终点: Percentage of Subjects Receiving no Opioid Rescue

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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.

研究组 & 干预措施

Cohort 1: HTX-011 + MMA Regimen

Experimental

HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.

干预措施: HTX-011 (Drug)

Cohort 1: HTX-011 + MMA Regimen

Experimental

HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.

干预措施: Luer lock applicator (Device)

Cohort 1: HTX-011 + MMA Regimen

Experimental

HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.

干预措施: Vial access device (Device)

Cohort 1: HTX-011 + MMA Regimen

Experimental

HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.

干预措施: Ibuprofen (Drug)

Cohort 1: HTX-011 + MMA Regimen

Experimental

HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.

干预措施: Acetaminophen (Drug)