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临床试验/NCT07100158
NCT07100158已完成不适用

The Diagnostic Value of Ultrasonographic Optic Nerve Sheath Diameter Measurement in Postdural Puncture Headache

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2025年8月8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
176
试验地点
1
主要终点
Incidence of Post-Dural Puncture Headache (PDPH)

研究概览

简要总结

This study aims to investigate the hypothesis that ultrasonographic optic nerve sheath diameter (ONSD) measurement can help predict the development and severity of postdural puncture headache (PDPH) in patients undergoing spinal anesthesia for total knee arthroplasty. PDPH is defined as a headache that worsens in an upright position and improves while lying down.

详细描述

This prospective observational study aims to investigate the role of ultrasonographically measured optic nerve sheath diameter (ONSD) in predicting the development and severity of post-dural puncture headache (PDPH) in patients undergoing total knee arthroplasty (TKA) under spinal anesthesia.

The study will include patients aged 18 to 65 years, with American Society of Anesthesiologists (ASA) physical status I or II, who are scheduled to undergo total knee prosthesis (TKP) surgery under spinal anesthesia, with successful administration using a 27G Quincke spinal needle on the first attempt. Exclusion criteria will include a history of central nervous system disorders (e.g., cerebrovascular diseases, intracranial hemorrhage, brain tumors), ophthalmological disorders, hypertension, hepatic encephalopathy, renal failure, pregnancy, history of chronic headache or migraine, obesity (body mass index >35 kg/m²), alcohol or substance dependence, psychiatric disorders, local infection at the injection site, allergy to local anesthetics, bleeding diathesis, requirement for sedation during the procedure, conditions that may impair postoperative cooperation (e.g., mental retardation, language acquisition deficits), and inability to obtain reliable optic nerve sheath diameter (ONSD) measurements.

Ultrasonographic ONSD measurements will be performed using a 7.5 MHz linear ultrasound probe preoperatively (baseline) and at 6, 12, 24, 36, and 48 hours postoperatively. PDPH will be defined as a headache that worsens in the sitting or standing position and improves when lying down. Headache severity will be assessed using the Numerical Rating Scale (NRS), in which patients rate their pain from 0 (no pain) to 10 (the worst pain imaginable). Postoperative pain related to surgery will also be assessed using the NRS, and the need for rescue analgesics will be documented (NRS ≥ 4). Intraoperative vital parameters, including heart rate and arterial blood pressure, will also be monitored. In addition to the incidence and severity of PDPH, associated symptoms (nausea, vomiting, photophobia, diplopia, auditory symptoms, neck pain, and dizziness) will be recorded. Patients who develop PDPH will be assigned to Group H, while those who do not will be assigned to Group C.

The primary aim of this study is to determine the diagnostic and prognostic value of ONSD measurements in predicting PDPH following spinal anesthesia.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 18 and 65 years
  • •ASA physical status I or II
  • •Scheduled for total knee arthroplasty under spinal anesthesia
  • •Successful spinal anesthesia with a single attempt using a 27G Quincke spinal needle
  • •Provided informed consent to participate in the study

排除标准

  • •History of neurological or central nervous system disorders (e.g., cerebrovascular disease, intracranial hemorrhage, brain tumor)
  • •Ophthalmological disorders
  • •Hypertension
  • •Hepatic encephalopathy
  • •Renal failure
  • •Pregnancy
  • •History of chronic headaches or migraine
  • •Obesity (BMI > 35 kg/m²)
  • •Alcohol or substance abuse
  • •Psychiatric disorders
  • •Local infection at the injection site
  • •Allergy to local anesthetics
  • •Bleeding diathesis
  • •Requirement for sedation during the procedure
  • •Inability to cooperate postoperatively (e.g., mental retardation, language deficits)
  • •Inability to obtain reliable ONSD measurements

结局指标

主要结局

Incidence of Post-Dural Puncture Headache (PDPH)

时间窗: Within 48 hours postoperatively

The proportion of patients who develop PDPH within the first 48 hours following spinal anesthesia. PDPH will be defined as a headache that worsens in the sitting or standing position and improves when lying down.

次要结局

  • Symptoms Associated with PDPH(Within 48 hours postoperatively)
  • Severity of Post-Dural Puncture Headache (PDPH)(Within 48 hours postoperatively)
  • Optic Nerve Sheath Diameter (ONSD) Measurement(At baseline (preoperative), and at 6, 12, 24, 36, and 48 hours postoperatively)
  • Postoperative Pain(Within 48 hours postoperatively)
  • Rescue Analgesic Requirement(Within 48 hours postoperatively)

研究者

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

Gökhan Erdem

Anesthesiology and Reanimation specialist doctor

Ankara City Hospital Bilkent

研究点 (1)

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