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Not yet recruitingNCT07497945Updated Mar 27, 2026

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

An observational study in Post Dural Puncture Headache, sponsored by Kocaeli University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Kocaeli University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
220
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Post Dural Puncture Headache

Keywords

  • Optic Nerve Sheath Diameter
  • Cesarean Section
  • Spinal Anesthesia
  • Obstetric Anesthesia
  • Ocular Ultrasound
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will consist of pregnant women aged 18-45 years undergoing cesarean section under spinal anesthesia at Kocaeli University Hospital. Participants who meet the eligibility criteria and provide informed consent will be enrolled.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
220 participants (estimated)
Patient registry
No

Interventions

  • OtherOptic Nerve Sheath Diameter Measurement

    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.

05

What researchers measure

Primary outcomes

  1. Association Between Optic Nerve Sheath Diameter Measurements and Post-Dural Puncture Headache

    Assessment of the association between optic nerve sheath diameter measurements and the development of post-dural puncture headache.

    Time frame: Within 48 hours after spinal anesthesia

06

Study locations

1 site
  • Kocaeli University Faculty of Medicine Hospital
    Köseköy, Kocaeli 41001, Turkey (Türkiye)
    • Dilara Ayaz Ozcan, MD · Contact · dlryz96@gmail.com · +905053932937
    • Tulay Sahin, MD · Contact · tulaydogac@gmail.com · +905322825454
    • Tulay Sahin, MD · Principal investigator
    • Dilara Ayaz Ozcan, MD · Sub investigator
07

References and documents

Publications

  • Richards E, Munakomi S, Mathew D. Optic Nerve Sheath Ultrasound. 2026 Jan 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554479/ PubMed 32119366 ↗
  • Sprigge JS, Harper SJ. Accidental dural puncture and post dural puncture headache in obstetric anaesthesia: presentation and management: a 23-year survey in a district general hospital. Anaesthesia. 2008 Jan;63(1):36-43. doi: 10.1111/j.1365-2044.2007.05285.x. PubMed 18086069 ↗
  • Peng Q, Wang J, Xia X, Li Y, Qiu C, Li J, Zhou H, Li Y, Zhang M. The Value of the Optic Nerve Sheath Diameter (ONSD) in Predicting Postdural Puncture Headache (PDPH): A Prospective Observational Study. Pain Physician. 2023 Jan;26(1):45-52. PubMed 36791293 ↗
  • Weji BG, Obsa MS, Melese KG, Azeze GA. Incidence and risk factors of postdural puncture headache: prospective cohort study design. Perioper Med (Lond). 2020 Nov 9;9(1):32. doi: 10.1186/s13741-020-00164-2. PubMed 33292510 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared in order to protect participant privacy and confidentiality. Only aggregated study results will be reported in scientific publications.

08

Registry details

Key details

Study ID
NCT07497945
Lead sponsor
Kocaeli University
Responsible party
Dilara Ayaz Özcan (Resident Physician, Department of Anesthesiology and Reanimation, Kocaeli University) — Principal investigator
First posted
Mar 27, 2026
Start date
Mar 20, 2026 (estimated)
Primary completion
Jan 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Mar 27, 2026

Study contacts

Dilara Ayaz Ozcan, MD
Contact
dlryz96@gmail.com
+905053932937
Tulay Sahin, MD
Contact
tulaydogac@gmail.com
+905322825454
Tulay Sahin, MD
principal investigator · Department of Anesthesiology and Reanimation Kocaeli University Faculty of Medicine Kocaeli, Turkey

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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