NCT05250830已完成不适用
Non-invasive bioELEctroniC Treatment foR pOst-cesarean paiN (ELECTRON)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups.
研究概览
简要总结
This is a randomized trial of 134 individualized post-cesarean delivery who will be randomized to twice daily use of non-invasive bioelectronic treatment with TrueRelief device or identical appearing sham device for post-cesarean pain management.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible) Singleton, or twin gestation
排除标准
- •Known history of opioid use disorder, by medical record review
- •Contraindication to opioids
- •Contraindications to both acetaminophen and ibuprofen
- •Significant surgical procedures (e.g., hysterectomy) prior to randomization as pain trajectory will be completely different
- •Fetal or neonatal death prior to randomization
- •Inability to randomize on postoperative day 0
- •Inability to participate in twice daily use of non-invasive bioelectronic treatment during inpatient stay as assessed by research staff
- •Language barrier (non-English or Spanish speaking)
- •Participation in another intervention study that influences the primary outcome in this trial
结局指标
主要结局
Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups.
时间窗: For primary day of cesarean to day of discharge (3 days)
The primary outcome is the total postoperative opioid intake through hospital discharge. All opioid doses were converted to equianalgesic doses of morphine sulfate MME using standard ratios.
次要结局
- Number of Participants Who Received Opioid Refill Prescription in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups After Discharge.(After discharge through study completion, an average of six weeks)
- Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.(At hospital discharge)
- Morphine Milligram Equivalents (MME) Opioid Tablets Prescribed at Discharge in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.(At the discharge up to 24 hours)
- Number of Participants With Pain Scores of Greater Than 4 (BPI Score >4) at Discharge.(At the discharge up to 24 hours.)
- Rate of Wound Infection or Separation in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.(After cesarean delivery until six weeks postpartum)
研究者
Kara M Rood, MD
Assistant Professor
Ohio State University
研究点 (2)
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