Post Dural Puncture HeadacheNCT07497945
Optic Nerve Sheath Diameter for Predicting Post-Dural Puncture Headache in Cesarean Section Patients
An observational study of Post Dural Puncture Headache, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Post Dural Puncture Headache
- What is being tested?
- Optic Nerve Sheath Diameter Measurement
- How many people
- 220 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2026to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kocaeli University Faculty of Medicine Hospital
Köseköy, Kocaeli, 41001
Dilara Ayaz Ozcan, MD, +905053932937, dlryz96@gmail.com
Tulay Sahin, MD, +905322825454, tulaydogac@gmail.com
About this study
Official title: Evaluation of Optic Nerve Sheath Diameter for Predicting Post-Dural Puncture Headache in Cesarean Section Patients: A Prospective Observational Study
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.
- Conditions
- Post Dural Puncture Headache
- Being tested
- Optic Nerve Sheath Diameter Measurement
- Keywords
- Optic Nerve Sheath Diameter, Cesarean Section, Spinal Anesthesia, Obstetric Anesthesia, Ocular Ultrasound
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic Nerve Sheath Diameter MeasurementOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 48 hours after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start20 Mar 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Dural Puncture HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Ayaz Özcan, Kocaeli University
- Investigators
- Tulay Sahin, MD, Principal investigator, Department of Anesthesiology and Reanimation Kocaeli University Faculty of Medicine Kocaeli, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497945
- Sponsor's protocol ID
- KU-TF-DAO-01
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 32119366Sprigge 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 18086069Peng 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 36791293Weji 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Optic Nerve Sheath Diameter for Predicting Post-Dural Puncture Headache in Cesarean Section Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07497945
- Acronym / sponsor ID
- KU-TF-DAO-01
- Conditions
- Post Dural Puncture Headache
- Keywords
- Optic Nerve Sheath Diameter, Cesarean Section, Spinal Anesthesia, Obstetric Anesthesia, Ocular Ultrasound
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optic Nerve Sheath Diameter MeasurementParticipants 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. | Other | – |
Primary outcome
Association Between Optic Nerve Sheath Diameter Measurements and Post-Dural Puncture Headache
Time frame: Within 48 hours after spinal anesthesia
Assessment of the association between optic nerve sheath diameter measurements and the development of post-dural puncture headache.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 32119366Richards 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/
- Background: PubMed 18086069Sprigge 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.
- Background: PubMed 36791293Peng 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.
- Background: PubMed 33292510Weji 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.
- Individual participant dataSharing planned: 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.
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Post-Dural Puncture Headache
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tulay Sahin, MD principal investigator
Department of Anesthesiology and Reanimation Kocaeli University Faculty of Medicine Kocaeli, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Dural Puncture Headache, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilara Ayaz Ozcan, MD (+905053932937, dlryz96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Optic Nerve Sheath Diameter Measurements and Post-Dural Puncture Headache (time frame: Within 48 hours after spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07497945, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.