Incidence of Post-Dural Puncture Headache Following Unintentional Dural Puncture: A Randomized Trial of Intrathecal Morphine Versus Saline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Participants Who Report Post Dural Puncture Headaches
研究概览
简要总结
The purpose of this study is to evaluate the use of intrathecal morphine administration following an unintentional dural puncture, to decrease the incidence of post dural puncture headaches (PDPH) in obstetric patients.
详细描述
Unintentional dural puncture is a known risk of neuraxial techniques, occurring in roughly 1% of all epidural catheter placements. The incidence of post dural puncture headaches(PDPH) after unintentional dural puncture (UDP) is 50-80%. A PDPH is defined as a headache that occurs following a dural puncture, worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying, with at least one of the following: neck stiffness, tinnitus, hypacusia, photophobia, or nausea. The headache develops within 5 days after dural puncture and resolves either spontaneously within 1 week or within 48 hours after effective treatment of the spinal fluid leak.
The rates of PDPH following unintentional dural puncture with placement of an intrathecal catheter will be compared in two groups: intrathecal morphine (treatment) versus intrathecal saline (control) administered 1-2 hours after delivery, followed by immediate catheter removal. Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Those randomized to the control group will receive normal saline 0.3 mL intrathecally. After administration of intrathecal morphine, all patients will have their respirations monitored every hour for a period of 12 hours and then every two hours for a period of 12 hours. On postpartum days 1-5, all patients will be visited daily while inpatient and/or contacted by phone after discharge from the hospital.
PDPH can lead to significant morbidity and negatively impact patient satisfaction with postpartum recovery. Along with headache, patients may develop cranial nerve palsy during the postpartum period leading to permanent disability. In addition, new mothers are unable to bond with their babies due to headache and associated symptoms of nausea, vomiting and limited mobility secondary to pain. Therefore, an effective intervention to decrease the risk of PDPH after UDP would be useful.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postpartum patients following vaginal delivery
- •Unintentional dural puncture
- •Functioning intrathecal catheter
- •Patients must be 18 years of age or older
- •English speaking.
排除标准
- •History of previous PDPH
- •Body mass index BMI > 40 kg/m2
- •History of obstructive sleep apnea (OSA)
- •Morphine allergy
- •Patients who receive Cesarean delivery
研究组 & 干预措施
Morphine
Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally.
干预措施: Morphine (Drug)
Saline
Patients randomized to the control group will receive normal saline 0.3 mL intrathecally.
干预措施: Saline (Drug)
结局指标
主要结局
Participants Who Report Post Dural Puncture Headaches
时间窗: 5 days
Participants who report post dural puncture headaches from delivery to postpartum day 5
次要结局
- Severity of Post Dural Puncture Headache(Time of unintentional dural puncture to postpartum day 5)
- Treatment Method for Headache(Unintentional dural puncture - Postpartum day 5)
- Presenting Day of Headache(Dural puncture to 5 days after delivery)
- Number of Participants With Duration in Days of Headache After Unintentional Dural Puncture.(5 days)
- Greatest Level of Headache Pain Experienced With the Unintentional Dural Puncture(5 days)
- Intrathecal Catheter Dwell Time(Insertion time to removal in minutes)
- Intrathecal Infusion Volume(Time of insertion of catheter to time catheter removed)
- Mode of Delivery(up to 10 hours after intrathecal catheter placed)
- Number of Participants With Cranial Nerve Symptoms(5 days)
- Repeat Epidural Blood Patch(After first epidural blood patch to 5 days after delivery)
研究者
Feyce M. Peralta, MD, MS
Assistant Professor in Anesthesiology
Northwestern University
