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Study of Post-Herniorrhaphy Non-opioid MMA Regimens

2026年5月8日 更新者：Heron Therapeutics

A Phase 3b, Randomized, Open-Label Study of HTX-011 as the Foundation of a Non-opioid, Multimodal Analgesic Regimen to Decrease Opioid Use Following Unilateral Open Inguinal Herniorrhaphy

This is a Phase 3b, open-label study to assess postoperative opioid use in subjects undergoing unilateral open inguinal herniorrhaphy with intraoperative administration of HTX-011 and a postoperative non-opioid multimodal analgesic (MMA) regimen. The study will be conducted in 2 sequential parts: Part 1 is randomized and Part 2 is Investigator's preference for MMA regimen.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

209

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Anaheim、California、美国、92801
        • Anaheim Clinical Trials, LLC
      • La Mesa、California、美国、91942
        • Sharp Grossmont Hospital
      • La Mesa、California、美国、91942
        • Horizon Clinical Research
      • Orange、California、美国、92868
        • University of California, Irvine Medical Center
      • Riverside、California、美国、92503
        • Parkview Community Hospital
    • Connecticut
      • New Haven、Connecticut、美国、06510
        • Yale University School Of Medicine
    • Florida
      • Miami、Florida、美国、33144
        • Medical Research of Westchester, Inc
      • St. Petersburg、Florida、美国、33713
        • Professional Health Care of Pinellas
    • Kentucky
      • Louisville、Kentucky、美国、40202
        • University of Louisville Hospital
    • Missouri
      • Dallas、Missouri、美国、75246
        • Baylor University Medical Center
      • St Louis、Missouri、美国、63110
        • Washington University School of Medicine
    • New Jersey
      • Newark、New Jersey、美国、07103
        • Rutgers - New Jersey Medical School
    • New York
      • Stony Brook、New York、美国、11794
        • Stony Brook University Hospital
      • The Bronx、New York、美国、10461
        • Montefiore Hutchinson Campus
    • North Carolina
      • Durham、North Carolina、美国、27704
        • M3 Emerging Medical Research, LLC
    • Ohio
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic
      • Cleveland、Ohio、美国、44111
        • Cleveland Clinic Fairview
      • Columbus、Ohio、美国、43210
        • The Ohio State University Wexner Medical Center - University Hospital
      • Dayton、Ohio、美国、45417
        • Midwest Clinical Research Center, LLC
    • Oregon
      • Bend、Oregon、美国、97701
        • Summit Medical Group Oregon-Bend Memorial Clinic
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19107
        • Thomas Jefferson University Hospital
      • Philadelphia、Pennsylvania、美国、19104
        • Penn Presbyterian Medical Center
      • Pittsburgh、Pennsylvania、美国、15232
        • UPMC Shadyside Hospital
      • Pittsburgh、Pennsylvania、美国、15237
        • UPMC Passavant
    • Texas
      • Dallas、Texas、美国、75246
        • Baylor University Medical Center
      • Houston、Texas、美国、77030
        • Houston Methodist Hospital
      • Houston、Texas、美国、77004
        • Hermann Drive Surgical Hospital
      • Plano、Texas、美国、75093
        • Plano Surgical Hospital
      • San Antonio、Texas、美国、78229
        • Endeavor Clinical Trials, LLC
    • Utah
      • Draper、Utah、美国、84020
        • JBR Clinical Research

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

Inclusion Criteria:

  • Is scheduled and medically fit to undergo an elective unilateral open inguinal herniorrhaphy with mesh under deep sedation or general anesthesia; no neuraxial technique (eg, no spinal or epidural).
  • Has an American Society of Anesthesiologists (ASA) 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:

  • 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.
  • Part 1 only: Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. Part 2 only: Has known or suspected history of persistent opioid use, defined as daily, or almost daily, use of opioids for a period of at least 30 days within the previous 6 months.
  • Has taken any opioids within 24 hours prior to the scheduled surgery.
  • Has a known or suspected history of drug abuse, has a positive drug screen on the day of surgery, consumes 3 or more alcoholic drinks every day, or has a recent history of alcohol abuse.
  • 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 .

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：HTX-011 + Alternating MMA Regimen
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake.
设备：鲁尔锁头
滴注器
药品：对乙酰氨基酚
1克
药品：Ibuprofen
600 mg
药品：HTX-011
300 mg bupivacaine/9 mg meloxicam
其他名称：
  • ZYNRELEF
实验性的：HTX-011 + Concurrent MMA Regimen
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake.
设备：鲁尔锁头
滴注器
药品：对乙酰氨基酚
1克
药品：Ibuprofen
600 mg
药品：HTX-011
300 mg bupivacaine/9 mg meloxicam
其他名称：
  • ZYNRELEF

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Proportion of Subjects Who do Not Receive an Opioid Prescription Through the Day 15 Visit
大体时间：Through Day 15
Through Day 15

次要结果测量

结果测量
措施说明
大体时间
Proportion of Subjects Who do Not Receive an Opioid Prescription at Discharge
大体时间：At discharge
Proportion of subjects who do not receive an opioid prescription at discharge (between 2 and 3 hours after surgery on average).
At discharge
Proportion of Subjects Who do Not Receive a Postdischarge Opioid Prescription, Through the Day 15 Visit.
大体时间：Postdischarge through Day 15
Postdischarge through Day 15
Pain Intensity Scores at the Time of Discharge
大体时间：At discharge
Pain intensity scores were assessed at discharge (between 2 and 3 hours after surgery on average) using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded with activity (NRS-A), sitting up from a resting position.
At discharge
Number of Oxycodone Pills Taken Between Discharge and the Day 15 Visit
大体时间：Postdischarge through Day 15
Postdischarge through Day 15
Mean TSQM-9 Scores
大体时间：Day 15 plus or minus 2 days
The TSQM-9 contains 9 items which make up the Effectiveness, Convenience, and Global Satisfaction domains; each domain includes 3 items. Scores for each domain were computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, with higher scores indicating higher satisfaction.
Day 15 plus or minus 2 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Heron Therapeutics

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年4月4日

初级完成 (实际的)

2021年10月25日

研究完成 (实际的)

2021年11月22日

研究注册日期

首次提交

2019年4月5日

首先提交符合 QC 标准的

2019年4月5日

首次发布 (实际的)

2019年4月8日

研究记录更新

最后更新发布 (实际的)

2026年6月4日

上次提交的符合 QC 标准的更新

2026年5月8日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HTX-011-304

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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