Predictive Value of ONSD and NIRS for PDPH
Predictive Value of Optic Nerve Sheath Diameter and Cerebral Oxygenation Changes for Post-Dural Puncture Headache in Obstetric Surgery
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.
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Altinordu
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Ordu, Altinordu, Turkey (Türkiye), 52200
- Recruiting
- Name: Ordu University Training and Research Hospital
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Contact:
- Yasir Ilyas, Assistant Professor
- Phone Number: +905073460233
- Email: ysrilyas@outlook.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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PDPH Group
Pregnant women undergoing elective cesarean section under spinal anesthesia who developed post-dural puncture headache (PDPH). Patients will be evaluated for the development of PDPH during the first 5 postoperative days. Inpatients will be assessed in their hospital rooms, while discharged patients will be followed up via daily telephone visits to determine the group placement. |
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Non-PDPH Group
Pregnant women undergoing elective cesarean section under spinal anesthesia who did not develop post-dural puncture headache (PDPH). Patients will be evaluated for the development of PDPH during the first 5 postoperative days. Inpatients will be assessed in their hospital rooms, while discharged patients will be followed up via daily telephone visits to determine the group placement. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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). |
Baseline (before spinal anesthesia), 10 minutes after spinal anesthesia, end of surgery, and 24 hours postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Cerebral Oxygenation (rSO2) Changes
Time Frame: intraoperative period
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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. |
intraoperative period
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The Incidence of Post-spinal Hypotension
Time Frame: intraoperative period
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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. |
intraoperative period
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OrduU-AR-YI-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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