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

NCT07497945 | Not Yet Recruiting

• 1 other identifier: KU-TF-DAO-01
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Dural Puncture Headache

Keywords

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

Outcome Measures

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.

  Within 48 hours after spinal anesthesia

Interventions

Optic Nerve Sheath Diameter Measurement OTHER

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The study includes only female participants because the research population consists of pregnant women undergoing cesarean section under spinal anesthesia.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University Faculty of Medicine Hospital

Köseköy, Kocaeli, 41001, Turkey (Türkiye)

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Tulay Sahin, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilara Ayaz Ozcan, MD

CONTACT

+905053932937; dlryz96@gmail.com

Tulay Sahin, MD

CONTACT

+905322825454; tulaydogac@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)