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临床试验/NCT07729449
NCT07729449招募中不适用

Predictive Value of Optic Nerve Sheath Diameter and Cerebral Oxygenation Changes for Post-Dural Puncture Headache in Obstetric Surgery

Ordu University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2026年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
44
试验地点
1
主要终点
Perioperative Optic Nerve Sheath Diameter (ONSD) Changes

研究概览

简要总结

Currently, there is no reliable and effective method available in clinical practice to predict the development of PDPH. Early prediction and prevention of PDPH would reduce the incidence of postoperative complications, thereby enhancing the quality of recovery and care for both the mother and the newborn.

In this study, by testing the hypothesis that ONSD changes occurring after spinal anesthesia in pregnant women scheduled for elective cesarean delivery are associated with the development of PDPH, a predictive cutoff value for ONSD will be determined to foresee this complication. As a secondary endpoint, we aimed to evaluate the monitoring of cerebral desaturation secondary to post-spinal hypotension via NIRS and to assess the clinical significance of these data in predicting the development of PDPH.

详细描述

Postdural puncture headache (PDPH) is defined as a headache that develops within five days following a dural puncture, is fundamentally caused by cerebrospinal fluid (CSF) leakage, and is characterized by neck stiffness, photophobia, and/or auditory symptoms. All cases involving a dural puncture during neuraxial block procedures are at risk for developing PDPH. The reported incidence following spinal anesthesia varies widely, ranging from 1% to 36% .The widespread use of neuraxial techniques in obstetric surgery has led to this complication being observed more frequently, particularly in the young female population.

Any delay in diagnosis or treatment can lead to serious, potentially life-threatening complications such as postpartum major depression, visual impairments, cranial nerve palsies, and subdural hematoma. PDPH and its associated complications not only reduce the mother's quality of life but also negatively impact the newborn care process.

The underlying factor in the accepted hypotheses regarding the pathophysiology of PDPH is excessive CSF loss. Changes in CSF volume can lead to changes in optic nerve sheath diameter (ONSD), which is surrounded by the meninges (arachnoid and dura). Due to the free exchange of CSF between the subarachnoid space and this region, changes in fluid volume result in the expansion or narrowing of the ONSD.

The validity of ultrasound-guided ONSD measurement in assessing intracranial pressure has been demonstrated; as a noninvasive and safe option, this method is utilized as a supportive tool for clinical diagnosis. The strong correlation between CSF pressure and ONSD dynamics highlights the potential of perioperative ONSD measurements in predicting the development of PDPH. This approach may carry clinical significance for patients presenting with high-risk factors, such as the use of a large-gauge needle, a low body mass index, and a prior history of headache or PDPH.

Following a decrease in intracranial CSF pressure, changes are also observed in cerebral vascular circulation. Under the Monro-Kellie doctrine, adenosine-mediated vasodilation occurs in vascular structures to compensate for the decreased CSF volume and lower intracranial pressure (ICP), leading to an increase in cerebral blood volume. Under physiological conditions, this compensatory vasodilation is expected to support cerebral blood flow (CBF), thereby maintaining or increasing cerebral oxygen saturation.

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

  • Patients aged 18-40 years,
  • American Society of Anesthesiologists (ASA) physical status classification of II or III,
  • Beyond 37 weeks of gestation,
  • Elective cesarean delivery,
  • Provided written informed consent

排除标准

  • Patients undergoing emergency cesarean delivery
  • Presence of preoperative anxiety [State-Trait Anxiety Inventory (STAI) - I] score > 30)
  • Presence of preoperative anemia (Hemoglobin < 11 g/dL),
  • History of hypertension, gestational hypertension, hyperthyroidism, or preeclampsia/eclampsia,
  • Presence of fetal and/or placental anomalies,
  • Known neurological, psychiatric, cardiovascular, or muscular diseases,
  • Chronic headache,
  • Active ocular disease or optic nerve damage,
  • Allergies to local anesthetics or other medications,
  • Requirement for intraoperative general anesthesia,
  • Presence of contraindications to neuraxial anesthesia or conversion to intraoperative general anesthesia,
  • Multiple puncture attempts during spinal anesthesia administration,
  • Development of postpartum hemorrhage.

结局指标

主要结局

Perioperative Optic Nerve Sheath Diameter (ONSD) Changes

时间窗: Baseline (before spinal anesthesia), 10 minutes after spinal anesthesia, end of surgery, and 24 hours postoperatively

Optic nerve sheath diameter (ONSD) measurements will be performed in patients in the supine position using a 7.5 megahertz linear ultrasound probe by an anesthesiologist with at least three years of experience and over one hundred procedure experiences. Imaging will be obtained in a plane perpendicular to the optic nerve axis through a thin layer of gel applied over closed eyelids. Measurements will be performed 3 mm behind the optic papilla, based on the outer hypoechoic margins. At the determined time points during the perioperative period, the arithmetic mean of a total of four measurements obtained in both transverse and sagittal planes for each eye will be recorded in the data tracking form as the final ONSD value. Optic nerve sheath diameter (ONSD) measurements (in mm) assessed via transorbital ultrasonography to evaluate its predictive value for the development of post-dural puncture headache (PDPH).

次要结局

  • Cerebral Oxygenation (rSO2) Changes(intraoperative period)
  • The Incidence of Post-spinal Hypotension(intraoperative period)

研究者

发起方
Ordu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasir Ilyas, MD

Assistant Professor

Ordu University

研究点 (1)

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