The Effect of a Charcoal Deactivation Pouch on Opioid Disposal After Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Actual pouch use
研究概览
简要总结
Background: There is scarce literature investigating how patients dispose of unused opioid supplies after their cesarean postoperative pain has faded. The Office of the Surgeon General has identified research on the prevention of opioid use disorder area as well as research on the management of pain as a "Surgeon General Priority" that needs urgent investigation.
Hypothesis: At least 33% of postpartum women discharged home with an opioid prescription and a drug deactivation pouch will use the pouch to dispose of remaining opioids within 30 days of delivery.
Methods: This is a prospective single arm interventional pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18+ at time of enrollment, per ERM
- •Delivered ≥26.0 weeks, per ERM
- •Status post low transverse cesarean delivery, per ERM
- •Physically located on labor & delivery and is postpartum day #1 or #2 at time of enrollment, per ERM
- •Opioid prescription has been sent (per ERM) or will be sent (per obstetric team).
排除标准
- •Positive urine toxicology anytime in pregnancy for non-prescription opioids, fentanyl, amphetamines, benzodiazepines, cannabinoids, LSD, or cocaine, per ERM.
- •Buprenorphine or methadone Rx, per ERM
- •Patient preferred communication language not English, per ERM
- •Documented history, per ERM:
- •Cannabinoid use disorder
- •Hypnotic use disorder
- •Opioid use disorder
- •Stimulant use disorder
- •Fibromyalgia
- •Sickle cell anemia
- •Lumbar disc herniation
- •Multiple sclerosis
- •Trigeminal neuralgia
- •Active cancer
- •Complex regional pain syndrome
- •Systemic lupus erythematosus
- •Rheumatoid arthritis
研究组 & 干预措施
Activated charcoal pouch
The patients in this arm will receive an activated charcoal pouch (Deterra Medium Pouch, UPC #: 850006727001, Verde Environmental Technologies, Minnetonka, MN) for disposal of their opioids after their cesarean delivery pain has resolved.
干预措施: Deterra activated charcoal pouch (Other)
结局指标
主要结局
Actual pouch use
时间窗: 30 days
The percentage of women who used the pouch to dispose of opioids in the home 30 days after delivery (%)
次要结局
未报告次要终点
研究者
Michael J. Paglia, MD PhD
Principal Investigator
Geisinger Clinic