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临床试验/NCT05116930
NCT05116930招募中2 期

Neostigmine and Glycopyrrolate for the Treatment of Post Dural Puncture Headache After Known Dural Puncture With a Tuohy Needle: A Pilot Study

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年11月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
发起方
Mayo Clinic
入组人数
18
试验地点
1
主要终点
Number of postpartum women requiring epidural blood patch

研究概览

简要总结

The purpose of this study is to evaluate Neostigmine and Glycopyrrolate to treat post-dural puncture headache (PDPH) to reduce the proportion of postpartum women with a PDPH requiring epidural blood patch (EBP) who developed a PDPH after accidental dural puncture.

详细描述

Hypothesis: Neostigmine and glycopyrrolate will reduce the proportion of postpartum women with a PDPH requiring EBP who developed a PDPH after accidental dural puncture with a Tuohy needle.

Background: The post dural puncture headache (PDPH) is a well-documented complication of dural puncture. Depending on a number of factors, the overall incidence of PDPH following dural puncture with an epidural Tuohy needle is typically around 50%, but can be as high as 70% for certain populations.

The headache is characterized as frontal or occipital in nature, with a typical onset of 6-72 hours after dural puncture. It is normally exacerbated by the upright position and improved by the supine position. Associated symptoms may include photophobia, nausea, vomiting, dizziness, tinnitus, neck stiffness, decreased hearing and visual changes. These symptoms tend to be extremely debilitating in affected patients, severely limiting their functional capacity until the resolution of the headache. The compromise is even greater in postpartum women who also need to care for a newborn, as the time after birth is important for forming attachment and encompasses many new obligations for the new mother.

The treatment of the PDPH often begins with conservative treatment including supportive therapies such as hydration, bed rest, acetaminophen, NSAIDs, and oral opioids. In addition, some evidence exists for the use of caffeine. While these do not hasten recovery, they may improve symptoms. For PDPH of all etiologies, 72% will resolve spontaneously in 7 days and 89% by 14 days.

For patients with moderate to severe symptoms or long lasting headaches, the gold standard for treatment of headaches that do not resolve is the epidural blood patch (EBP). This treatment has been shown to be effective in 70-98% of patients. However, it has numerous contraindications including fever, infection, coagulopathy, active neurological disease, patient refusal. In addition, a potential complication is yet another dural puncture. Also, while the EBP is generally very safe, it is an invasive procedure with its own complications; it has been associated with very rare but serious complications including: moderate long-lasting backache, meningitis, epidural abscess formation, epidural hematoma formation, and neurologic deficit development.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 54 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Post-dural puncture headache (PDPH) after documented dural puncture with Tuohy needle during placement of epidural analgesia for labor and no other explanation for headache (HA).
  • Onset of HA within 72 hours of delivery.

排除标准

  • Patient refusal.
  • Visual analog scale (NRS) score <
  • History of migraine headaches.
  • Arrhythmia.
  • Heart block.
  • Myasthenia gravis.
  • Inability to understand pain scores and other questionnaires.
  • Inability to speak English.
  • Contraindication to acetaminophen or NSAIDs.
  • Temperature > 38.5 C.
  • Prior EBP done for this HA.

研究组 & 干预措施

Postpartum dural puncture headache following dural puncture from Tuohy needle

Experimental

Subjects identified as experienced a post dural puncture headache after a confirmed dural puncture from a Tuohy needle will receive an IV administration of the study medications neostigmine and glycopyrrolate.

干预措施: Neostigmine (Drug)

Postpartum dural puncture headache following dural puncture from Tuohy needle

Experimental

Subjects identified as experienced a post dural puncture headache after a confirmed dural puncture from a Tuohy needle will receive an IV administration of the study medications neostigmine and glycopyrrolate.

干预措施: Glycopyrrolate (Drug)

结局指标

主要结局

Number of postpartum women requiring epidural blood patch

时间窗: 2 weeks

Total number of postpartum women with a post dural puncture headache (PDPH) requiring epidural blood patch (EBP)

次要结局

  • Change in pain scores(Baseline, 1 hour, 8 hours, 16 hours, 24 hours, 48 hours, 1 week, and 2 weeks after intervention)
  • Adverse Events(2 weeks)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark D. Rollins

Principal Investigator

Mayo Clinic

研究点 (1)

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