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临床试验/NCT03464253
NCT03464253已完成不适用

Transcranial Doppler Role in Prediction of Post-dural Puncture Headache in Parturients Undergoing Elective Caesarean Section

Zagazig University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
TCD is able to predict the occurrence of PDPH in female patients undergoing spinal anesthesia for elective Caesarean Section

研究概览

简要总结

The parturients are at particular risk of post dural puncture headache (PDPH) because of their sex, young age, and the widespread application of spinal and epidural anesthesia. PDPH has a negative impact on quality of life, patient satisfaction, the postpartum experience with the mother's inability to bond with and care for her baby and it increases the economic burden associated with childbirth. Therefore, it is necessary to prevent or decrease its incidence and severity.

TCD enables measurement of the blood flow velocity in intracranial arteries and its parameters are affected by both fluctuations in intracranial pressure and changes in cerebral vessel diameters. The possibility of equipment mobilization, the opportunity of repeated bedside technique together with the noninvasive nature, makes TCD measurements attractive in the attempt to estimate CBF and offers potential application to predict and follow patients with PDPH.

详细描述

PDPH is described as severe "searing and spreading like hot metal" distributed over the occipital and frontal areas radiating to the neck and shoulders. 90% of headache will occur within three days of the procedure, and 66% within the first 48 hours. The PDPH rarely develops between 5 and 14 days after the technique however it may immediately occur after dural puncture but it is rare and should pay attention of the physician to alternative causes. The pain is increased by head movement, upright posture and relieved by lying down. It resolves either spontaneously within 7 days or within 48 h after effective treatment which is usually consists of fluid therapy, analgesics, sumatriptan and caffeine. Epidural blood patch remained the gold standard therapy but it is an invasive technique.

The exact etiology of PDPH is unknown; there is two hypothesis attempts to explain the cause. First it's known that dural tear leads to cerebrospinal fluid (CSF) leak and decreased volume of CSF result in intracranial hypotension which cause on pain sensitive intracranial structures that become stretched when assuming upright position result in pain. Second, intracranial volume is constant and equal to the sum of intracranial blood, CSF, and brain matter. After loss of CSF a compensatory reflex vasodilatation occur in the same pain sensitive blood vessels and this result in pain.

The association of common risk factors like female gender, particularly females during pregnancy, age groups of 20 - 40 years, a prior history of chronic headache, and a lower body mass index expose the patient to PDPH. The identification of factors that predict the likelihood of PDPH is important so that measures can be taken to minimize this painful complication resulting from spinal anesthesia.

Transcranial Doppler ultrasound (TCD) is a portable, safe, noninvasive and real-time tool for assessing intracranial blood hemodynamics. The first description of the technique was by Rune Aaslid in early 20th century and it has gained increasing acceptance as an accurate diagnostic and therapeutic tool in both cerebrovascular disease and neurocritical care. TCD enables measurement of the blood flow velocity in intracranial arteries and several Studies have shown that its parameters are affected by both fluctuations in intracranial pressure and changes in cerebral vessel diameters. So, as PDPH may be resulted from significant changes in cerebral blood flow, it could be visualized by TCD.

The possibility of equipment mobilization, the opportunity of repeated bedside technique together with the noninvasive nature, makes TCD measurements attractive in the attempt to estimate CBF and offers potential application to predict and follow patients with PDPH.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient acceptance.
  • Pregnant female undergoing Elective caesarean section under spinal anesthesia.
  • Age 18-40 years old.
  • ASA I and ASA II.
  • Accepted mental state of the patient.

排除标准

  • Patient refusal.
  • Contraindications to regional anesthesia as local infection, coagulopathy,....etc
  • ASA Grade 3 and
  • Emergent caesarean section.
  • Inadequate temporal window.
  • Hypertensive disorders of the pregnancy.
  • Atrial fibrillation.
  • Significant fetal illness.
  • History of allergy to local anesthetics.

结局指标

主要结局

TCD is able to predict the occurrence of PDPH in female patients undergoing spinal anesthesia for elective Caesarean Section

时间窗: 5 days

The group of patients who developed PDPH will be identified and their pre puncture cerebral blood flow measurements by TCD will be compared with the corresponding measurements of PDPH free patients to correlate the pre-puncture measurements with the occurrence of PDPH.

次要结局

  • verify that lumber puncture in PDPH patients leads to significant changes in cerebral blood flow supporting the theory of cerebral vasodilatation in PDPH patients.(5 days)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sherif M. S. Mowafy

lecturer of Anesthesia and Surgical Intensive Care

Zagazig University

研究点 (1)

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