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NCT Number: NCT07729449

Predictive Value of ONSD and NIRS for PDPH

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Name: Ordu University Training and Research Hospital

Ordu, Altinordu, 52200, Turkey (Türkiye)

Location status: Recruiting

Location contact

Yasir Ilyas, Assistant Professor

CONTACT

[email protected]

+905073460233

About this study

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.

However, spinal anesthesia, which is frequently preferred in cesarean delivery, leads to post-spinal hypotension in 70-80% of cases due to the accompanying sympathetic blockade and systemic vasodilation in the lower extremities. Consequently, venous return and cardiac output decrease, leading to a reduction in systemic perfusion pressure. Therefore, although the Monro-Kellie doctrine triggers intracranial vasodilation (and theoretically increases cerebral blood volume), the concurrently developing severe post-spinal systemic hypotension may exceed the limits of cerebral autoregulation, setting the stage for a drop in net cerebral perfusion pressure and CBF velocity. This conflicting physiological process may lead to cerebral desaturation when compensatory mechanisms prove insufficient.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Perioperative Optic Nerve Sheath Diameter (ONSD) Changes

    Time frame: 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).

Secondary outcomes

  1. Cerebral Oxygenation (rSO2) Changes

    Time frame: intraoperative period

    The incidence of cerebral desaturation following spinal anesthesia will be monitored. Cerebral oxygen saturation (R-NIRS and L-NIRS) will be continuously monitored using NIRS. A decrease in any of the NIRS values of 20% or more relative to baseline within the first 20 minutes will be defined as "cerebral desaturation." In the event of cerebral desaturation, oxygen support will first be optimized; after ruling out potential mechanical factors and bleeding, a norepinephrine infusion will be initiated to optimize cerebral perfusion pressure. The total amount of norepinephrine consumption will be recorded in the data tracking form.

    Cerebral Oxygenation values will be recorded in the data form every 3 minutes for the first 15 minutes following spinal anesthesia, and every 5 minutes during the remainder of the intraoperative period.

  2. The Incidence of Post-spinal Hypotension

    Time frame: intraoperative period

    The incidence of post-spinal hypotension will be recorded. Post-spinal hypotension will be defined as a decrease in MAP of 20% or more relative to baseline, or an absolute mean arterial pressure (MAP) value falling below 65 mmHg within the first 20 minutes following spinal anesthesia. In patients who develop hypotension, normotension will be targeted using hydration and administration of ephedrine/norepinephrine, and the total amounts of vasopressors (ephedrine and norepinephrine) administered will be recorded in the data tracking form.

    MAP values will be recorded in the data form every 3 minutes for the first 15 minutes following spinal anesthesia, and every 5 minutes during the remainder of the intraoperative period.

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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