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Clinical Trials in Turkey / NCT07729449
Recruiting Observational

Predictive Value of ONSD and NIRS for PDPH

NCT07729449 · tracked via the Priya Life Science Turkey tracker
Sponsor
Ordu University
Phase
Observational
Started
2026-06-19
Last updated
2026-07-27

Condition(s) studied

Post-Dural Puncture HeadacheSpinal Anesthetics Causing Adverse Effects in Therapeutic Use

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Perioperative Optic Nerve Sheath Diameter (ONSD) Changes — 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).

Trial sites (1)

FacilityCityRegionStatus
Name: Ordu University Training and Research Hospital Ordu Altinordu Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07729449 on ClinicalTrials.gov ↗ ← All trials in Turkey