Mitigating Opioid Use Disorder Risk With Enhanced Opioid Sparing Pain Relief for Wisdom Teeth Extractions With a Novel Nanotechnology
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Opioid Consumption
研究概览
简要总结
This is a randomized (1:1), placebo-controlled clinical trial that will examine the feasibility and effectiveness of a 2-day application of the NeuroCuple device for pain relief and reduction of opioid use following wisdom teeth extraction. The primary objectives are to determine whether the active NeuroCuple reduces postoperative pain and decreases opioid consumption compared to a sham (placebo) device. A total of 120 participants will be enrolled over a 1-year period and randomized to receive either the active device or an identical-appearing placebo device without the captor array layer.
详细描述
This will be a triple-blind randomized (1:1) placebo-controlled clinical trial to determine the feasibility and effectiveness of a 2-days only 12-18h/day, mostly at night application of the NeuroCuple for reducing surgical pain and opioid use after third molar extraction. Study subjects, 18-40y, will be followed on days 1, 7, 1 month, and 3 months post-extraction via REDCap surveys with text, email, or phone reminders. Results will establish NeuroCuple as an effective non-opioid pain management approach for post-dental extraction pain. Importantly, we have a sham that looks exactly like the active device, allowing us to conduct a robust triple-blinded RCT. We have designed a prototype specific for this STTR's dental extraction indication with the device inside a sleeve over the cheek that wraps around the head with feedback from dentists and patients for easier and better use compliance, efficacy, FDA indication and reimbursement
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females of all races and ethnicity
- •>18 to 50 years
- •Healthy based on medical history
- •Scheduled for elective extraction of one or more partially or fully impacted mandibular third molars
- •Able to understand and sign the informed consent form
- •Willing and able to comply with all study procedures
- •Available for the duration of the study
- •Able to understand the directions for data gathering instruments
排除标准
- •Children (< 18 years of age)
- •T-score ≥ 60 in any of the three PROMIS measures (i.e., sleep, anxiety, and depression)
- •Other concomitant surgery being performed in addition to third molar extraction
- •History of gastrointestinal bleeding and/or peptic ulcer, renal disease (excluding kidney stones), hepatic disease, bleeding disorder, respiratory depression
- •History of respiratory depression with opioids or other anesthetic drugs that required postoperative ventilatory support or naloxone
- •Active or untreated asthma
- •Known allergy to ibuprofen, acetaminophen, oxycodone, hydrocodone, and/or anesthesia
- •Currently taking CYP3A4 inhibitors, azole-antifungal agents, protease inhibitors, or CNS depressants
- •Consumes three or more alcoholic drinks per day
- •Active alcoholism or illicit drug abuse (defined as daily use of illicit drugs)
- •History of substance or alcohol abuse
- •History of substance or alcohol abuse in a first-degree relative
- •No more than one opioid prescription filled within the past 12 months (self-report and PDMP)
- •Pregnant or lactating women
- •Sex, race, and ethnicity will not be used as exclusion criteria.
研究组 & 干预措施
NEUROCUPLE™ Group
This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-days following their Wisdom Teeth Extraction procedure
干预措施: NEUROCUPLE™ Patch (Device)
Sham Group
This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-days following their Wisdom Tooth Extraction procedure
干预措施: Sham Patch (Device)
结局指标
主要结局
Opioid Consumption
时间窗: First 48 hours post extraction
Total prescription opioid use in Oral Morphine Milligram Equivalent (MME) in first 48 hours
次要结局
- Opioid Consumption(post-extraction Day 7)
- Opioid Consumption(post-extraction Day 30)
- Opioid Consumption(post-extraction Day 90)
- Post-Operative Pain Score(48 hours post-extraction)
- Opioid prescription refills(One week post extraction)
- Opioid prescription refills(post-extraction day 30)
- Opioid prescription refills(post-extraction day 90)
- Pain Interference(post-extraction days 1-7, 30 days and 90 days)
- Daily use of non-opioid analgesics(post-extraction days 1-7)
- Time to normalcy (work or activity, and solid food intake)(post-extraction days 1-7)
- Adverse events (i.e., ER visit, hospitalization, opioid side-effects, intervention side effects)(post-extraction days 1-7)
- Sleep quality(post-extraction days 1-7)
- Risk of opioid misuse and abuse using Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R)(post-extraction day 7, 1 month, and 3 months.)
- Protocol adherence in first 48 hours(48 hours post-extraction)
- patient satisfaction(48 hours post-extraction)