NCT03907176已完成3 期
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
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 58
- 主要终点
- Proportion of subjects who do not receive an opioid prescription at discharge through the day 15 visit
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 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.
排除标准
- •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 .
结局指标
主要结局
Proportion of subjects who do not receive an opioid prescription at discharge through the day 15 visit
时间窗: Discharge through Day 15
次要结局
- Proportion of subjects who do not receive a postdischarge opioid prescription, through the Day 15 visit.(Postdischarge through Day 15)
- Number of oxycodone pills taken between discharge and the Day 15 visit(Postdischarge through Day 15)
- Proportion of subjects who do not receive an opioid prescription at discharge(At discharge)
- Pain intensity scores at the time of discharge(At discharge)
- Mean TSQM-9 scores(Day 15 plus or minus 2 days)
研究者
研究点 (58)
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