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Optic Nerve Sheath Diameter for Predicting Post-Dural Puncture Headache in Cesarean Section Patients

Evaluation of Optic Nerve Sheath Diameter for Predicting Post-Dural Puncture Headache in Cesarean Section Patients: A Prospective Observational Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07497945
Enrollment
220
Registered
2026-03-27
Start date
2026-03-20
Completion date
2027-03-31
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Dural Puncture Headache

Keywords

Optic Nerve Sheath Diameter, Cesarean Section, Spinal Anesthesia, Obstetric Anesthesia, Ocular Ultrasound

Brief summary

Some patients develop headache after spinal anesthesia used during cesarean section. This condition is called post-dural puncture headache (PDPH). Early identification of patients at risk may improve patient care. This study evaluates whether optic nerve sheath diameter (ONSD), measured using a non-invasive bedside ocular ultrasound technique, can help predict the development of PDPH. Participants undergoing cesarean section with spinal anesthesia will undergo ONSD measurements at predefined perioperative time points. Participants will be followed postoperatively for the occurrence of headache. The findings may help improve early recognition and management of PDPH.

Detailed description

Post-dural puncture headache (PDPH) is a common complication after spinal anesthesia, particularly in patients undergoing cesarean section. It is thought to occur due to cerebrospinal fluid leakage and decreased intracranial pressure. Optic nerve sheath diameter (ONSD) measured by ocular ultrasound reflects changes in intracranial pressure and may help identify patients at risk for PDPH. This prospective observational study aims to evaluate the predictive value of serial ONSD measurements for the development of PDPH in patients undergoing cesarean section under spinal anesthesia. Non-invasive bedside ultrasound measurements of ONSD will be performed at predefined perioperative time points. Participants will be followed postoperatively to assess the occurrence of headache. The results of this study may help improve early identification of patients at risk for PDPH and enhance postoperative management.

Interventions

Participants will undergo non-invasive ocular ultrasound measurement of optic nerve sheath diameter at five predefined time points: preoperatively, 10 minutes after spinal anesthesia, at the end of surgery, at postoperative 24 hours, and at postoperative 48 hours.

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Women aged 18 to 45 years * Singleton pregnancy * Planned cesarean section (elective or emergency due to fetal indications) * Spinal anesthesia planned for the procedure * American Society of Anesthesiologists (ASA) physical status II-III * Normal coagulation parameters (INR less than 1.5, platelet count greater than 100,000/mm³) * Ability to provide written informed consent and cooperate with study procedures

Exclusion criteria

* Known ophthalmologic diseases affecting the optic nerve or retina (e.g., glaucoma, optic atrophy) * Active eye infection or recent ocular surgery * Known intracranial pathology affecting cerebrospinal fluid dynamics (e.g., intracranial mass, hydrocephalus, idiopathic intracranial hypertension) * History of stroke or subarachnoid hemorrhage * Hypertensive disorders of pregnancy such as preeclampsia or eclampsia * Contraindications to spinal anesthesia (e.g., coagulopathy, anticoagulant therapy, infection at puncture site) * Allergy to local anesthetics * Conversion to general anesthesia due to failed or inadequate spinal block * Presence of moderate or severe preoperative headache or active primary headache disorders such as migraine

Design outcomes

Primary

MeasureTime frameDescription
Association Between Optic Nerve Sheath Diameter Measurements and Post-Dural Puncture HeadacheWithin 48 hours after spinal anesthesiaAssessment of the association between optic nerve sheath diameter measurements and the development of post-dural puncture headache.

Countries

Turkey (Türkiye)

Contacts

CONTACTDilara Ayaz Ozcan, MD
dlryz96@gmail.com+905053932937
CONTACTTulay Sahin, MD
tulaydogac@gmail.com+905322825454
PRINCIPAL_INVESTIGATORTulay Sahin, MD

Department of Anesthesiology and Reanimation Kocaeli University Faculty of Medicine Kocaeli, Turkey

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026