Predicting Post-Dural Puncture Headache After Spinal Anesthesia in Cesarean Deliveries
Official title: Predictive Value of Optic Nerve Sheath Diameter and Cerebral Oxygenation Changes for Post-Dural Puncture Headache in Obstetric Surgery
Run by Ordu University · NCT07729449 · Data updated 2026-11-12
This study tests whether changes in optic nerve sheath diameter after spinal anesthesia can predict who will develop a post-dural puncture headache in pregnant women having an elective cesarean.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 44 (estimated) |
| Sponsor | Ordu University Academic / other |
| Locations | 1 site (Ordu, Altinordu) |
| Status | Recruiting |
| Started | June 19, 2026 |
| Main results expected | June 14, 2027 |
| Study ends | June 19, 2027 |
| Registry record updated | July 27, 2026 |
| Trial ID | NCT07729449 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women aged 18-40, at or beyond 37 weeks, undergoing elective cesarean delivery, ASA II-III, who consent to participate.
✕Probably not a fit
Patients who do not develop PDPH or who do not show ONSD/NIRS changes may not experience a direct benefit from the testing.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates whether ultrasound measurements of optic nerve sheath diameter (ONSD) after spinal anesthesia correlate with the onset of post-dural puncture headache (PDPH) in women at term undergoing cesarean delivery. It also explores whether monitoring cerebral oxygenation with near-infrared spectroscopy (NIRS) during spinal-induced hypotension provides additional predictive value for PDPH. The goal is to establish a potential ONSD cutoff to foresee PDPH and to assess the clinical relevance of NIRS-derived cerebral desaturation in this context. Eligible participants are 18-40 years old, ASA II-III, past 37 weeks gestation, undergoing elective cesarean delivery, and able to consent. The study is conducted at Ordu University with the lead sponsor listed as Ordu University.
Why it matters
Potential benefit: If successful, clinicians could identify high-risk patients early and take preventive or targeted measures to reduce PDPH and related complications.
How similar studies have gone: Prior work supports the use of ONSD as a noninvasive proxy for intracranial dynamics, but application to PDPH prediction in obstetric spinal anesthesia is still exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Name: Ordu University Training and Research Hospital
Ordu, Altinordu, Turkey (Türkiye) Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.