Post-Dural Puncture HeadachePDPHPatientsNCT06957899
Optic Nerve Sheath Diameter in Postspinal Headache
An observational study of Post-Dural Puncture Headache, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the relationship between spinal needle size and optic nerve sheath diameter (ONSD) in patients who develop post-dural puncture headache (PDPH) after spinal anesthesia. ONSD is measured using ultrasound, which helps estimate changes in brain pressure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-Dural Puncture Headache
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 5 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 to 75 years who develop post-dural puncture headache (PDPH) following spinal anesthesia. All participants are evaluated and monitored at a tertiary care center and are classified as ASA physical status I to III.
Who may be able to join
- Patients diagnosed with postdural puncture headache (PDPH)
- Male and female patients aged 18-75 years
- Patients classified as American Society of Anesthesiologists (ASA) physical status I-III
Who cannot join
- Presence of neurological or ophthalmological disorders
- History of head trauma within the past 6 months
- Hypertension
- Hepatic encephalopathy
- Renal failure
- Pregnancy
Show all 11Show fewer
- History of chronic headache or migraine
- Refusal to participate
- Inability to obtain reliable optic nerve sheath diameter (ONSD) measurements
- Communication difficulties preventing assessment
- Incomplete or inaccessible medical records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Spinal Needle Gauge on Optic Nerve Sheath Diameter in Patients With Post-Dural Puncture Headache
This study aims to investigate the relationship between spinal needle size and optic nerve sheath diameter (ONSD) in patients who develop post-dural puncture headache (PDPH) after spinal anesthesia. ONSD is measured using ultrasound, which helps estimate changes in brain pressure. The study also examines whether the severity of headache is related to ONSD. Adult patients aged 18 to 75 years who develop PDPH will be included. This research will be conducted at Konya City Hospital and is expected to last for approximately six months.
Read the detailed description
This prospective observational study investigates the relationship between spinal needle gauge and optic nerve sheath diameter (ONSD) in patients who develop post-dural puncture headache (PDPH) following spinal anesthesia. ONSD is measured using ultrasound as a non-invasive marker of intracranial pressure. The study also aims to evaluate the association between headache severity, assessed by the Visual Analog Scale (VAS), and ONSD values. Patients aged 18-75 years with PDPH will be included, and data on spinal needle gauge, ONSD, and VAS scores will be analyzed. The study is being conducted at a single tertiary care center and aims to contribute to understanding the physiopathology of PDPH and its relation to procedural factors.
- Conditions
- Post-Dural Puncture Headache
- Keywords
- Post-Dural Puncture Headache (PDPH), Intracranial Hypotension, Spinal Anesthesia Complication, Optic Nerve Sheath Diameter, Spinal Needle Gauge
- Medical subject headings
- Post-Dural Puncture Headache, Intracranial 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 |
|---|---|---|
| Group 25 | Group 25G: Patients who underwent spinal anesthesia with a 25-gauge needle | |
| Group 27 | Group 27G: Patients who underwent spinal anesthesia with a 27-gauge needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter (ONSD)
The primary outcome is the measurement of optic nerve sheath diameter (ONSD) via ocular ultrasound in patients who develop postoperative headache attributed to dural puncture. This non-invasive assessment is used to estimate intracranial pressure. The aim is to evaluate whether different spinal needle gauges affect ONSD measurements.
Measured: Within 4 hours of anesthesia consultation for postoperative headache
Secondary outcomes (1)
Pain severity assessed by Visual Analog Scale (VAS)
Pain severity will be scored using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), during the anesthesia consultation conducted for postoperative headache. This measure will be compared with ONSD values.
Measured: Within 4 hours of anesthesia consultation for postoperative headache
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 Jul 2025
- Primary completion30 Sep 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuran Akıncı Ekinci, Konya City Hospital
- Investigators
- Nuran AKINCI EKİNCİ, Study chair, Konya City Hospiital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957899
- Sponsor's protocol ID
- 2025/38
- Acronym
- PDPHPatients
- Status last verified
- May 2025
- First submitted
- 12 Apr 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang P, Zhou X, Sheng F, Wang X, Shi C, Feng W. Ultrasonic optic nerve sheath diameter can be used as a diagnostic measure after accidental dural puncture during cesarean section: a case report. BMC Anesthesiol. 2024 Jan 22;24(1):35. doi: 10.1186/s12871-024-02418-8.
PubMed 38254029Dubost C, Le Gouez A, Zetlaoui PJ, Benhamou D, Mercier FJ, Geeraerts T. Increase in optic nerve sheath diameter induced by epidural blood patch: a preliminary report. Br J Anaesth. 2011 Oct;107(4):627-30. doi: 10.1093/bja/aer186. Epub 2011 Jun 21.
PubMed 21693468
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Spinal Needle Gauge on Optic Nerve Sheath Diameter in Patients With Post-Dural Puncture Headache
- ClinicalTrials.gov ID
- NCT06957899
- Acronym / sponsor ID
- PDPHPatients / 2025/38
- Conditions
- Post-Dural Puncture Headache
- Keywords
- Post-Dural Puncture Headache (PDPH), Intracranial Hypotension, Spinal Anesthesia Complication, Optic Nerve Sheath Diameter, Spinal Needle Gauge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 6 May 2025 (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.
This study aims to investigate the relationship between spinal needle size and optic nerve sheath diameter (ONSD) in patients who develop post-dural puncture headache (PDPH) after spinal anesthesia. ONSD is measured using ultrasound, which helps estimate changes in brain pressure. The study also examines whether the severity of headache is related to ONSD. Adult patients aged 18 to 75 years who develop PDPH will be included. This research will be conducted at Konya City Hospital and is expected to last for approximately six months.
Detailed description
This prospective observational study investigates the relationship between spinal needle gauge and optic nerve sheath diameter (ONSD) in patients who develop post-dural puncture headache (PDPH) following spinal anesthesia. ONSD is measured using ultrasound as a non-invasive marker of intracranial pressure. The study also aims to evaluate the association between headache severity, assessed by the Visual Analog Scale (VAS), and ONSD values. Patients aged 18-75 years with PDPH will be included, and data on spinal needle gauge, ONSD, and VAS scores will be analyzed. The study is being conducted at a single tertiary care center and aims to contribute to understanding the physiopathology of PDPH and its relation to procedural factors.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 25 | – | –Group 25G: Patients who underwent spinal anesthesia with a 25-gauge needle |
| Group 27 | – | –Group 27G: Patients who underwent spinal anesthesia with a 27-gauge needle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 to 75 years who develop post-dural puncture headache (PDPH) following spinal anesthesia. All participants are evaluated and monitored at a tertiary care center and are classified as ASA physical status I to III.
Key inclusion criteria (3 listed)
- Patients diagnosed with postdural puncture headache (PDPH)
- Male and female patients aged 18-75 years
- Patients classified as American Society of Anesthesiologists (ASA) physical status I-III
Key exclusion criteria (11 listed)
- Presence of neurological or ophthalmological disorders
- History of head trauma within the past 6 months
- Hypertension
- Hepatic encephalopathy
- Renal failure
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
Optic nerve sheath diameter (ONSD)
Time frame: Within 4 hours of anesthesia consultation for postoperative headache
The primary outcome is the measurement of optic nerve sheath diameter (ONSD) via ocular ultrasound in patients who develop postoperative headache attributed to dural puncture. This non-invasive assessment is used to estimate intracranial pressure. The aim is to evaluate whether different spinal needle gauges affect ONSD measurements.
1 secondary outcome
Pain severity assessed by Visual Analog Scale (VAS)
Time frame: Within 4 hours of anesthesia consultation for postoperative headache
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Background: PubMed 38254029Wang P, Zhou X, Sheng F, Wang X, Shi C, Feng W. Ultrasonic optic nerve sheath diameter can be used as a diagnostic measure after accidental dural puncture during cesarean section: a case report. BMC Anesthesiol. 2024 Jan 22;24(1):35. doi: 10.1186/s12871-024-02418-8.
- Background: PubMed 21693468Dubost C, Le Gouez A, Zetlaoui PJ, Benhamou D, Mercier FJ, Geeraerts T. Increase in optic nerve sheath diameter induced by epidural blood patch: a preliminary report. Br J Anaesth. 2011 Oct;107(4):627-30. doi: 10.1093/bja/aer186. Epub 2011 Jun 21.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Nuran AKINCI EKİNCİ study chair
Konya City Hospiital
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 Konya City Hospital 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 9 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve sheath diameter (ONSD) (time frame: Within 4 hours of anesthesia consultation for postoperative headache). 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 NCT06957899, which also lists 2 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 9 Dec 2025.