Menu
Not yet recruiting NCT07497945

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

— Observational Post Dural Puncture Headache

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optic Nerve Sheath Diameter Measurement.
Who it may be relevant to
Registry conditions: Post Dural Puncture Headache. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other Optic 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.

Primary outcome measures

  • Association Between Optic Nerve Sheath Diameter Measurements and Post-Dural Puncture Headache [Time frame: Within 48 hours after spinal anesthesia]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Kocaeli University Faculty of Medicine Hospital — Köseköy

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/ PMID 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. PMID 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. PMID 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. PMID 33292510

Identifiers

NCT: NCT07497945 · KU-TF-DAO-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗