Post-Dural Puncture HeadacheNCT07729449
Predictive Value of ONSD and NIRS for PDPH
An observational study of Post-Dural Puncture Headache and Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
Currently, there is no reliable and effective method available in clinical practice to predict the development of PDPH. Early prediction and prevention of PDPH would reduce the incidence of postoperative complications, thereby enhancing the quality of recovery and care for both the mother and the newborn. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Post-Dural Puncture Headache, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2026to 19 Jun 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women aged 18-40 years who are scheduled to undergo elective cesarean section under spinal anesthesia at the tertiary care hospital.
Who may be able to join
- Patients aged 18-40 years,
- American Society of Anesthesiologists (ASA) physical status classification of II or III,
- Beyond 37 weeks of gestation,
- Elective cesarean delivery,
- Provided written informed consent
Who cannot join
- Patients undergoing emergency cesarean delivery
- Presence of preoperative anxiety [State-Trait Anxiety Inventory (STAI) - I] score > 30)
- Presence of preoperative anemia (Hemoglobin < 11 g/dL),
- History of hypertension, gestational hypertension, hyperthyroidism, or preeclampsia/eclampsia,
- Presence of fetal and/or placental anomalies,
- Known neurological, psychiatric, cardiovascular, or muscular diseases,
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- Chronic headache,
- Active ocular disease or optic nerve damage,
- Allergies to local anesthetics or other medications,
- Requirement for intraoperative general anesthesia,
- Presence of contraindications to neuraxial anesthesia or conversion to intraoperative general anesthesia,
- Multiple puncture attempts during spinal anesthesia administration,
- Development of postpartum hemorrhage.
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, 1 recruiting
- Recruiting
Name: Ordu University Training and Research Hospital
Ordu, Altinordu, 52200
Yasir Ilyas, Assistant Professor, +905073460233, ysrilyas@outlook.com
About this study
Official title: Predictive Value of Optic Nerve Sheath Diameter and Cerebral Oxygenation Changes for Post-Dural Puncture Headache in Obstetric Surgery
Currently, there is no reliable and effective method available in clinical practice to predict the development of PDPH. Early prediction and prevention of PDPH would reduce the incidence of postoperative complications, thereby enhancing the quality of recovery and care for both the mother and the newborn.
In this study, by testing the hypothesis that ONSD changes occurring after spinal anesthesia in pregnant women scheduled for elective cesarean delivery are associated with the development of PDPH, a predictive cutoff value for ONSD will be determined to foresee this complication. As a secondary endpoint, we aimed to evaluate the monitoring of cerebral desaturation secondary to post-spinal hypotension via NIRS and to assess the clinical significance of these data in predicting the development of PDPH.
Read the detailed description
Postdural puncture headache (PDPH) is defined as a headache that develops within five days following a dural puncture, is fundamentally caused by cerebrospinal fluid (CSF) leakage, and is characterized by neck stiffness, photophobia, and/or auditory symptoms. All cases involving a dural puncture during neuraxial block procedures are at risk for developing PDPH. The reported incidence following spinal anesthesia varies widely, ranging from 1% to 36% .The widespread use of neuraxial techniques in obstetric surgery has led to this complication being observed more frequently, particularly in the young female population.
Any delay in diagnosis or treatment can lead to serious, potentially life-threatening complications such as postpartum major depression, visual impairments, cranial nerve palsies, and subdural hematoma. PDPH and its associated complications not only reduce the mother's quality of life but also negatively impact the newborn care process.
The underlying factor in the accepted hypotheses regarding the pathophysiology of PDPH is excessive CSF loss. Changes in CSF volume can lead to changes in optic nerve sheath diameter (ONSD), which is surrounded by the meninges (arachnoid and dura). Due to the free exchange of CSF between the subarachnoid space and this region, changes in fluid volume result in the expansion or narrowing of the ONSD.
The validity of ultrasound-guided ONSD measurement in assessing intracranial pressure has been demonstrated; as a noninvasive and safe option, this method is utilized as a supportive tool for clinical diagnosis. The strong correlation between CSF pressure and ONSD dynamics highlights the potential of perioperative ONSD measurements in predicting the development of PDPH. This approach may carry clinical significance for patients presenting with high-risk factors, such as the use of a large-gauge needle, a low body mass index, and a prior history of headache or PDPH.
Following a decrease in intracranial CSF pressure, changes are also observed in cerebral vascular circulation. Under the Monro-Kellie doctrine, adenosine-mediated vasodilation occurs in vascular structures to compensate for the decreased CSF volume and lower intracranial pressure (ICP), leading to an increase in cerebral blood volume. Under physiological conditions, this compensatory vasodilation is expected to support cerebral blood flow (CBF), thereby maintaining or increasing cerebral oxygen saturation.
However, spinal anesthesia, which is frequently preferred in cesarean delivery, leads to post-spinal hypotension in 70-80% of cases due to the accompanying sympathetic blockade and systemic vasodilation in the lower extremities. Consequently, venous return and cardiac output decrease, leading to a reduction in systemic perfusion pressure. Therefore, although the Monro-Kellie doctrine triggers intracranial vasodilation (and theoretically increases cerebral blood volume), the concurrently developing severe post-spinal systemic hypotension may exceed the limits of cerebral autoregulation, setting the stage for a drop in net cerebral perfusion pressure and CBF velocity. This conflicting physiological process may lead to cerebral desaturation when compensatory mechanisms prove insufficient.
Currently, there is no reliable and effective method available in clinical practice to predict the development of PDPH. Early prediction and prevention of PDPH would reduce the incidence of postoperative complications, thereby enhancing the quality of recovery and care for both the mother and the newborn.
In this study, by testing the hypothesis that ONSD changes occurring after spinal anesthesia in pregnant women scheduled for elective cesarean delivery are associated with the development of PDPH, a predictive cutoff value for ONSD will be determined to foresee this complication. As a secondary endpoint, we aimed to evaluate the monitoring of cerebral desaturation secondary to post-spinal hypotension via NIRS and to assess the clinical significance of these data in predicting the development of PDPH.
- Conditions
- Post-Dural Puncture Headache, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
- Keywords
- Cesarean Sections, Spinal Anesthesia, Low Blood Pressure, Regional Cerebral Blood Flow, Post-Dural Puncture Headache
- Medical subject headings
- Post-Dural Puncture Headache, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PDPH Group | Pregnant women undergoing elective cesarean section under spinal anesthesia who developed post-dural puncture headache (PDPH). Patients will be evaluated for the development of PDPH during the first 5 postoperative days. Inpatients will be assessed in their hospital rooms, while discharged patients will be followed up via daily telephone visits to determine the group placement. | |
| Non-PDPH Group | Pregnant women undergoing elective cesarean section under spinal anesthesia who did not develop post-dural puncture headache (PDPH). Patients will be evaluated for the development of PDPH during the first 5 postoperative days. Inpatients will be assessed in their hospital rooms, while discharged patients will be followed up via daily telephone visits to determine the group placement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Optic Nerve Sheath Diameter (ONSD) Changes
Optic nerve sheath diameter (ONSD) measurements will be performed in patients in the supine position using a 7.5 megahertz linear ultrasound probe by an anesthesiologist with at least three years of experience and over one hundred procedure experiences. Imaging will be obtained in a plane perpendicular to the optic nerve axis through a thin layer of gel applied over closed eyelids. Measurements will be performed 3 mm behind the optic papilla, based on the outer hypoechoic margins. At the determined time points during the perioperative period, the arithmetic mean of a total of four measurements obtained in both transverse and sagittal planes for each eye will be recorded in the data tracking form as the final ONSD value.
Optic nerve sheath diameter (ONSD) measurements (in mm) assessed via transorbital ultrasonography to evaluate its predictive value for the development of post-dural puncture headache (PDPH).
Measured: Baseline (before spinal anesthesia), 10 minutes after spinal anesthesia, end of surgery, and 24 hours postoperatively
Secondary outcomes (2)
Cerebral Oxygenation (rSO2) Changes
The incidence of cerebral desaturation following spinal anesthesia will be monitored. Cerebral oxygen saturation (R-NIRS and L-NIRS) will be continuously monitored using NIRS. A decrease in any of the NIRS values of 20% or more relative to baseline within the first 20 minutes will be defined as "cerebral desaturation." In the event of cerebral desaturation, oxygen support will first be optimized; after ruling out potential mechanical factors and bleeding, a norepinephrine infusion will be initiated to optimize cerebral perfusion pressure. The total amount of norepinephrine consumption will be recorded in the data tracking form.
Cerebral Oxygenation values will be recorded in the data form every 3 minutes for the first 15 minutes following spinal anesthesia, and every 5 minutes during the remainder of the intraoperative period.
Measured: intraoperative period
The Incidence of Post-spinal Hypotension
The incidence of post-spinal hypotension will be recorded. Post-spinal hypotension will be defined as a decrease in MAP of 20% or more relative to baseline, or an absolute mean arterial pressure (MAP) value falling below 65 mmHg within the first 20 minutes following spinal anesthesia. In patients who develop hypotension, normotension will be targeted using hydration and administration of ephedrine/norepinephrine, and the total amounts of vasopressors (ephedrine and norepinephrine) administered will be recorded in the data tracking form.
MAP values will be recorded in the data form every 3 minutes for the first 15 minutes following spinal anesthesia, and every 5 minutes during the remainder of the intraoperative period.
Measured: intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start19 Jun 2026
- Primary completion14 Jun 2027 (estimated)
- Study completion19 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasir Ilyas, MD, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729449
- Sponsor's protocol ID
- OrduU-AR-YI-02
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Optic Nerve Sheath Diameter and Cerebral Oxygenation Changes for Post-Dural Puncture Headache in Obstetric Surgery
- ClinicalTrials.gov ID
- NCT07729449
- Acronym / sponsor ID
- OrduU-AR-YI-02
- Conditions
- Post-Dural Puncture Headache, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
- Keywords
- Cesarean Sections, Spinal Anesthesia, Low Blood Pressure, Regional Cerebral Blood Flow, Post-Dural Puncture Headache
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 19 Jun 2026 (actual)
- Primary completion
- 14 Jun 2027 (estimated)
- Study completion
- 19 Jun 2027 (estimated)
- First posted
- 27 Jul 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.
Currently, there is no reliable and effective method available in clinical practice to predict the development of PDPH. Early prediction and prevention of PDPH would reduce the incidence of postoperative complications, thereby enhancing the quality of recovery and care for both the mother and the newborn.
In this study, by testing the hypothesis that ONSD changes occurring after spinal anesthesia in pregnant women scheduled for elective cesarean delivery are associated with the development of PDPH, a predictive cutoff value for ONSD will be determined to foresee this complication. As a secondary endpoint, we aimed to evaluate the monitoring of cerebral desaturation secondary to post-spinal hypotension via NIRS and to assess the clinical significance of these data in predicting the development of PDPH.
Detailed description
Postdural puncture headache (PDPH) is defined as a headache that develops within five days following a dural puncture, is fundamentally caused by cerebrospinal fluid (CSF) leakage, and is characterized by neck stiffness, photophobia, and/or auditory symptoms. All cases involving a dural puncture during neuraxial block procedures are at risk for developing PDPH. The reported incidence following spinal anesthesia varies widely, ranging from 1% to 36% .The widespread use of neuraxial techniques in obstetric surgery has led to this complication being observed more frequently, particularly in the young female population.
Any delay in diagnosis or treatment can lead to serious, potentially life-threatening complications such as postpartum major depression, visual impairments, cranial nerve palsies, and subdural hematoma. PDPH and its associated complications not only reduce the mother's quality of life but also negatively impact the newborn care process.
The underlying factor in the accepted hypotheses regarding the pathophysiology of PDPH is excessive CSF loss. Changes in CSF volume can lead to changes in optic nerve sheath diameter (ONSD), which is surrounded by the meninges (arachnoid and dura). Due to the free exchange of CSF between the subarachnoid space and this region, changes in fluid volume result in the expansion or narrowing of the ONSD.
The validity of ultrasound-guided ONSD measurement in assessing intracranial pressure has been demonstrated; as a noninvasive and safe option, this method is utilized as a supportive tool for clinical diagnosis. The strong correlation between CSF pressure and ONSD dynamics highlights the potential of perioperative ONSD measurements in predicting the development of PDPH. This approach may carry clinical significance for patients presenting with high-risk factors, such as the use of a large-gauge needle, a low body mass index, and a prior history of headache or PDPH.
Following a decrease in intracranial CSF pressure, changes are also observed in cerebral vascular circulation. Under the Monro-Kellie doctrine, adenosine-mediated vasodilation occurs in vascular structures to compensate for the decreased CSF volume and lower intracranial pressure (ICP), leading to an increase in cerebral blood volume. Under physiological conditions, this compensatory vasodilation is expected to support cerebral blood flow (CBF), thereby maintaining or increasing cerebral oxygen saturation.
However, spinal anesthesia, which is frequently preferred in cesarean delivery, leads to post-spinal hypotension in 70-80% of cases due to the accompanying sympathetic blockade and systemic vasodilation in the lower extremities. Consequently, venous return and cardiac output decrease, leading to a reduction in systemic perfusion pressure. Therefore, although the Monro-Kellie doctrine triggers intracranial vasodilation (and theoretically increases cerebral blood volume), the concurrently developing severe post-spinal systemic hypotension may exceed the limits of cerebral autoregulation, setting the stage for a drop in net cerebral perfusion pressure and CBF velocity. This conflicting physiological process may lead to cerebral desaturation when compensatory mechanisms prove insufficient.
Currently, there is no reliable and effective method available in clinical practice to predict the development of PDPH. Early prediction and prevention of PDPH would reduce the incidence of postoperative complications, thereby enhancing the quality of recovery and care for both the mother and the newborn.
In this study, by testing the hypothesis that ONSD changes occurring after spinal anesthesia in pregnant women scheduled for elective cesarean delivery are associated with the development of PDPH, a predictive cutoff value for ONSD will be determined to foresee this complication. As a secondary endpoint, we aimed to evaluate the monitoring of cerebral desaturation secondary to post-spinal hypotension via NIRS and to assess the clinical significance of these data in predicting the development of PDPH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDPH Group | – | –Pregnant women undergoing elective cesarean section under spinal anesthesia who developed post-dural puncture headache (PDPH). Patients will be evaluated for the development of PDPH during the first 5 postoperative days. Inpatients will be assessed in their hospital rooms, while discharged patients will be followed up via daily telephone visits to determine the group placement. |
| Non-PDPH Group | – | –Pregnant women undergoing elective cesarean section under spinal anesthesia who did not develop post-dural puncture headache (PDPH). Patients will be evaluated for the development of PDPH during the first 5 postoperative days. Inpatients will be assessed in their hospital rooms, while discharged patients will be followed up via daily telephone visits to determine the group placement. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women aged 18-40 years who are scheduled to undergo elective cesarean section under spinal anesthesia at the tertiary care hospital.
Key inclusion criteria (5 listed)
- Patients aged 18-40 years,
- American Society of Anesthesiologists (ASA) physical status classification of II or III,
- Beyond 37 weeks of gestation,
- Elective cesarean delivery,
- Provided written informed consent
Key exclusion criteria (13 listed)
- Patients undergoing emergency cesarean delivery
- Presence of preoperative anxiety [State-Trait Anxiety Inventory (STAI) - I] score > 30)
- Presence of preoperative anemia (Hemoglobin < 11 g/dL),
- History of hypertension, gestational hypertension, hyperthyroidism, or preeclampsia/eclampsia,
- Presence of fetal and/or placental anomalies,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perioperative Optic Nerve Sheath Diameter (ONSD) Changes
Time frame: Baseline (before spinal anesthesia), 10 minutes after spinal anesthesia, end of surgery, and 24 hours postoperatively
Optic nerve sheath diameter (ONSD) measurements will be performed in patients in the supine position using a 7.5 megahertz linear ultrasound probe by an anesthesiologist with at least three years of experience and over one hundred procedure experiences. Imaging will be obtained in a plane perpendicular to the optic nerve axis through a thin layer of gel applied over closed eyelids. Measurements will be performed 3 mm behind the optic papilla, based on the outer hypoechoic margins. At the determined time points during the perioperative period, the arithmetic mean of a total of four measurements obtained in both transverse and sagittal planes for each eye will be recorded in the data tracking form as the final ONSD value. Optic nerve sheath diameter (ONSD) measurements (in mm) assessed via transorbital ultrasonography to evaluate its predictive value for the development of post-dural puncture headache (PDPH).
2 secondary outcomes
Cerebral Oxygenation (rSO2) Changes
Time frame: intraoperative period
The Incidence of Post-spinal Hypotension
Time frame: intraoperative period
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 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Name: Ordu University Training and Research Hospital
Ordu, Turkey (Türkiye)
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 and Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Ordu 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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 27 Jul 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Optic Nerve Sheath Diameter (ONSD) Changes (time frame: Baseline (before spinal anesthesia), 10 minutes after spinal anesthesia, end of surgery, and 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2026.