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临床试验/NCT06957899
NCT06957899已完成不适用

Impact of Spinal Needle Gauge on Optic Nerve Sheath Diameter in Patients With Post-Dural Puncture Headache

Konya City Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Optic nerve sheath diameter (ONSD)

研究概览

简要总结

This study aims to investigate the relationship between spinal needle size and optic nerve sheath diameter (ONSD) in patients who develop post-dural puncture headache (PDPH) after spinal anesthesia. ONSD is measured using ultrasound, which helps estimate changes in brain pressure. The study also examines whether the severity of headache is related to ONSD. Adult patients aged 18 to 75 years who develop PDPH will be included. This research will be conducted at Konya City Hospital and is expected to last for approximately six months.

详细描述

This prospective observational study investigates the relationship between spinal needle gauge and optic nerve sheath diameter (ONSD) in patients who develop post-dural puncture headache (PDPH) following spinal anesthesia. ONSD is measured using ultrasound as a non-invasive marker of intracranial pressure. The study also aims to evaluate the association between headache severity, assessed by the Visual Analog Scale (VAS), and ONSD values. Patients aged 18-75 years with PDPH will be included, and data on spinal needle gauge, ONSD, and VAS scores will be analyzed. The study is being conducted at a single tertiary care center and aims to contribute to understanding the physiopathology of PDPH and its relation to procedural factors.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients diagnosed with postdural puncture headache (PDPH)
  • •Male and female patients aged 18-75 years
  • •Patients classified as American Society of Anesthesiologists (ASA) physical status I-III

排除标准

  • •Presence of neurological or ophthalmological disorders
  • •History of head trauma within the past 6 months
  • •Hypertension
  • •Hepatic encephalopathy
  • •Renal failure
  • •Pregnancy
  • •History of chronic headache or migraine
  • •Refusal to participate
  • •Inability to obtain reliable optic nerve sheath diameter (ONSD) measurements
  • •Communication difficulties preventing assessment
  • •Incomplete or inaccessible medical records

结局指标

主要结局

Optic nerve sheath diameter (ONSD)

时间窗: Within 4 hours of anesthesia consultation for postoperative headache

The primary outcome is the measurement of optic nerve sheath diameter (ONSD) via ocular ultrasound in patients who develop postoperative headache attributed to dural puncture. This non-invasive assessment is used to estimate intracranial pressure. The aim is to evaluate whether different spinal needle gauges affect ONSD measurements.

次要结局

  • Pain severity assessed by Visual Analog Scale (VAS)(Within 4 hours of anesthesia consultation for postoperative headache)

研究者

发起方
Konya City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nuran Akıncı Ekinci

MD, Specialist in Anesthesiology

Konya City Hospital

研究点 (1)

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