Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery: A Prospective Double Blind Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Opioid Consumption in MME
研究概览
简要总结
Patients presenting for normal spontaneous vaginal delivery who have a neuraxial anesthestic will be randomized to receive preservative free morphine or saline placebo after delivery.
详细描述
After obtaining consent, women presenting to the labor floor at Mount Sinai Hospital will be randomized into two groups, intervention and placebo. Baseline demographic data and surveys in regards to postpartum depression, anxiety, breastfeed willingness and pain scores will be obtained. After delivery of the baby patients will either receive 2mg preservative free morphine or saline via the epidural catheter prior to its removal. The study team will then record pain and recovery scores, as well as follow up screens to the aforementioned endpoints. The study will end at the 6 week postpartum visit with the patient's obstetrician.
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)
盲法说明
The only individual that will know to which group the patient was assigned is the individual on the study team who is drawing up the medication. This individual will have no other role in the assessment or evaluation of the patient.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women in labor
排除标准
- •Not a candidate for neuraxial anesthesia
- •Patient refusal
- •Allergy to morphine
- •Patients with chronic pain syndromes
研究组 & 干预措施
Morphine
2mg preservative free morphine
干预措施: Preservative Free Morphine (Drug)
Saline
4 mL preservative free saline
干预措施: Saline (Drug)
结局指标
主要结局
Opioid Consumption in MME
时间窗: within 24 hours of delivery
Quantity of opioid in morphine milligram equivalents (MME) used within 24 hours of delivery. The conversions from opioids to MME were as follows: 2 mg oral hydromorphone as 8 MME, 5 mg oxycodone 7.5 MME. To convert the PO hydromorphone to MME, IV hydromorphone was converted to morphine with a 4:1 ratio to convert to morphine followed by a 1:3 ratio to convert IV to PO.
次要结局
- Obstetric Quality of Recovery Score (OBSQ10)(24 hours)
- Pain Score(at 24 hours)
- Number of Participants With Edinburgh Postnatal Depression Scale (EPDS) >10(up to 6 weeks)
- Number of Participants With Exclusive Breast Feeding(1 week)
研究者
Daniel Katz
Associate Professor
Icahn School of Medicine at Mount Sinai