Menu
Not yet recruiting NCT07360756

Ultrasonographic ONSD as a Predictor of PDPH in Spinal Anesthesia for Cesarean Delivery

— Observational Cesarean Section Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Study Cohort (Single Cohort).
Who it may be relevant to
Registry conditions: Cesarean Section Complications. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Early Prediction of Post-Dural Puncture Headache Using Ultrasound-Measured Optic Nerve Sheath Diameter in Cesarean Section Patients: A Prospective Observational Study

Overview

The Optic Nerve Sheath Diameter (ONSD), measured non-invasively by bedside ultrasound, is a well-established surrogate for intracranial pressure (ICP), as the optic nerve sheath is continuous with the intracranial dura mater and its subarachnoid space is filled with cerebrospinal fluid (CSF). While ONSD is typically used to detect elevated ICP (with a cut-off often \> 5.0-5.7 mm for ICP \> 20 mmHg), studies investigating PDPH have paradoxically shown a reduction in ONSD post-spinal anesthesia, correlating with the state of intracranial hypotension. Previous research has demonstrated that a lower ONSD or a significant decrease in ONSD values 24 hours post-puncture is associated with PDPH development. A study determined that an ONSD at 24 hours of less than 0.40 cm was the best predictor for PDPH. Our study aims to specifically investigate the utility of the immediate change in ONSD to offer a bedside, real-time assessment of risk.

Interventions

  • Procedure Study Cohort (Single Cohort)
    This study comprises a single, prospectively enrolled cohort of 150 adult female patients (ASA physical status II-III) scheduled for elective cesarean section under standardized spinal anesthesia. All participants receive the same planned intervention (spinal anesthesia for surgery) and undergo the same standardized measurement protocol for Optic Nerve Sheath Diameter (ONSD). Within this cohort, participants are naturally divided by outcome during follow-up into two groups for analytical purpose

Primary outcome measures

  • Optimal Delta ONSD cut-off value for predicting PDPH [Time frame: 72 hours post-spinal.]
Secondary outcome measures (2)
  • Post-Dural Puncture Headache (PDPH) [Time frame: 72h.]
  • The Need for Epidural Blood Patch (EBP) [Time frame: 72 hour]

Eligibility criteria

Inclusion criteria

  • Adult female patients, aged 18-45 years
  • ASA(American Society of Anesthesiologists) physical status II or III
  • Scheduled for elective cesarean section
  • Undergoing surgery under standardized spinal anesthesia

Exclusion criteria

  • Pre-existing headache disorders (e.g., migraine, chronic tension-type headache)
  • Known ophthalmic conditions (e.g., optic neuropathy, glaucoma)
  • Inability to cooperate with ONSD(Optic Nerve Sheath Diameter) ultrasound measurements or follow-up
  • Allergy to local anesthetics
  • Emergency cesarean section
  • Contraindications to spinal anesthesia:
  • Coagulopathy
  • Infection at the puncture site
  • Preexisting hypertension on medication
  • Pre-eclampsia with severe features (suggested for separate study)
  • Known cardiac disease with hemodynamic instability
  • Allergy to study drugs
  • Fetal distress or non-reassuring cardiotocography (CTG)
  • Body Mass Index (BMI) >40 kg/m²
  • Refusal to sign informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Al-Azhar University — Cairo

Identifiers

NCT: NCT07360756 · RC. 1.12.2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗