Anesthesia, LocalNCT07100158
Ultrasonographic Optic Nerve Sheath Diameter in Postdural Puncture Headache Diagnosis
An observational study of Anesthesia, Local and Headache, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the hypothesis that ultrasonographic optic nerve sheath diameter (ONSD) measurement can help predict the development and severity of postdural puncture headache (PDPH) in patients undergoing spinal anesthesia for total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, Local, Headache
- What is being tested?
- Ultrasonographic Measurement of Optic Nerve Sheath Diameter (ONSD)
- How many people
- 176 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2025to 7 Feb 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 to 65 years undergoing total knee arthroplasty under spinal anesthesia.
Who may be able to join
- Age between 18 and 65 years
- ASA physical status I or II
- Scheduled for total knee arthroplasty under spinal anesthesia
- Successful spinal anesthesia with a single attempt using a 27G Quincke spinal needle
- Provided informed consent to participate in the study
Who cannot join
- History of neurological or central nervous system disorders (e.g., cerebrovascular disease, intracranial hemorrhage, brain tumor)
- Ophthalmological disorders
- Hypertension
- Hepatic encephalopathy
- Renal failure
- Pregnancy
Show all 16Show fewer
- History of chronic headaches or migraine
- Obesity (BMI > 35 kg/m²)
- Alcohol or substance abuse
- Psychiatric disorders
- Local infection at the injection site
- Allergy to local anesthetics
- Bleeding diathesis
- Requirement for sedation during the procedure
- Inability to cooperate postoperatively (e.g., mental retardation, language deficits)
- Inability to obtain reliable ONSD measurements
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Çankaya, Ankara, 06800
About this study
Official title: The Diagnostic Value of Ultrasonographic Optic Nerve Sheath Diameter Measurement in Postdural Puncture Headache
This study aims to investigate the hypothesis that ultrasonographic optic nerve sheath diameter (ONSD) measurement can help predict the development and severity of postdural puncture headache (PDPH) in patients undergoing spinal anesthesia for total knee arthroplasty. PDPH is defined as a headache that worsens in an upright position and improves while lying down.
Read the detailed description
This prospective observational study aims to investigate the role of ultrasonographically measured optic nerve sheath diameter (ONSD) in predicting the development and severity of post-dural puncture headache (PDPH) in patients undergoing total knee arthroplasty (TKA) under spinal anesthesia.
The study will include patients aged 18 to 65 years, with American Society of Anesthesiologists (ASA) physical status I or II, who are scheduled to undergo total knee prosthesis (TKP) surgery under spinal anesthesia, with successful administration using a 27G Quincke spinal needle on the first attempt. Exclusion criteria will include a history of central nervous system disorders (e.g., cerebrovascular diseases, intracranial hemorrhage, brain tumors), ophthalmological disorders, hypertension, hepatic encephalopathy, renal failure, pregnancy, history of chronic headache or migraine, obesity (body mass index >35 kg/m²), alcohol or substance dependence, psychiatric disorders, local infection at the injection site, allergy to local anesthetics, bleeding diathesis, requirement for sedation during the procedure, conditions that may impair postoperative cooperation (e.g., mental retardation, language acquisition deficits), and inability to obtain reliable optic nerve sheath diameter (ONSD) measurements.
Ultrasonographic ONSD measurements will be performed using a 7.5 MHz linear ultrasound probe preoperatively (baseline) and at 6, 12, 24, 36, and 48 hours postoperatively. PDPH will be defined as a headache that worsens in the sitting or standing position and improves when lying down. Headache severity will be assessed using the Numerical Rating Scale (NRS), in which patients rate their pain from 0 (no pain) to 10 (the worst pain imaginable). Postoperative pain related to surgery will also be assessed using the NRS, and the need for rescue analgesics will be documented (NRS ≥ 4). Intraoperative vital parameters, including heart rate and arterial blood pressure, will also be monitored. In addition to the incidence and severity of PDPH, associated symptoms (nausea, vomiting, photophobia, diplopia, auditory symptoms, neck pain, and dizziness) will be recorded. Patients who develop PDPH will be assigned to Group H, while those who do not will be assigned to Group C.
The primary aim of this study is to determine the diagnostic and prognostic value of ONSD measurements in predicting PDPH following spinal anesthesia.
- Conditions
- Anesthesia, Local, Headache
- Being tested
- Ultrasonographic Measurement of Optic Nerve Sheath Diameter (ONSD)
- Keywords
- Optic Nerve Sheath Diameter, Post-Dural Puncture Headache, Spinal Anesthesia
- Medical subject headings
- Headache, Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic Measurement of Optic Nerve Sheath Diameter (ONSD)Other
Non-invasive ultrasonographic measurement of optic nerve sheath diameter (ONSD) using a 7.5 MHz linear probe at predefined time points: preoperative and postoperative 6, 12, 24, 36, and 48 hours.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-Dural Puncture Headache (PDPH)
The proportion of patients who develop PDPH within the first 48 hours following spinal anesthesia. PDPH will be defined as a headache that worsens in the sitting or standing position and improves when lying down.
Measured: Within 48 hours postoperatively
Secondary outcomes (5)
Optic Nerve Sheath Diameter (ONSD) Measurement
ONSD will be measured via ultrasonography using a 7.5 MHz linear probe placed over the closed upper eyelid with a thin layer of gel. Two measurements will be obtained in transverse and sagittal planes for each eye, and the average of four measurements will be recorded as the final ONSD value.
Measured: At baseline (preoperative), and at 6, 12, 24, 36, and 48 hours postoperatively
Severity of Post-Dural Puncture Headache (PDPH)
Headache severity will be assessed using the 0-10 Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain. Assessments will be conducted in patients who develop PDPH.
Measured: Within 48 hours postoperatively
Symptoms Associated with PDPH
Presence of associated symptoms such as nausea, vomiting, photophobia, diplopia, hearing disturbances, neck pain, and dizziness will be recorded in patients diagnosed with PDPH. Symptoms will be defined based on patient reports and clinical assessment
Measured: Within 48 hours postoperatively
Postoperative Pain
Pain at the surgical site will be assessed using the 11-point Numerical Rating Scale (NRS), where 0 indicates "no pain" and 10 indicates "the worst pain imaginable." Pain scores will be recorded regardless of the presence of PDPH.
Measured: Within 48 hours postoperatively
Rescue Analgesic Requirement
Patients with postoperative pain scored 4 or higher on the 0-10 Numerical Rating Scale (NRS) will receive 100 mg of intravenous tramadol as rescue analgesia. The total number of administered rescue analgesic doses will be recorded.
Measured: Within 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start8 Aug 2025
- Primary completion9 Dec 2025
- Study completion7 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökhan Erdem, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100158
- Sponsor's protocol ID
- ONSD
- Status last verified
- Feb 2026
- First submitted
- 27 Jul 2025
- Last updated
- 10 Feb 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of Ultrasonographic Optic Nerve Sheath Diameter Measurement in Postdural Puncture Headache
- ClinicalTrials.gov ID
- NCT07100158
- Acronym / sponsor ID
- ONSD
- Conditions
- Anesthesia, Local, Headache
- Keywords
- Optic Nerve Sheath Diameter, Post-Dural Puncture Headache, Spinal Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 7 Feb 2026 (actual)
- First posted
- 3 Aug 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 hypothesis that ultrasonographic optic nerve sheath diameter (ONSD) measurement can help predict the development and severity of postdural puncture headache (PDPH) in patients undergoing spinal anesthesia for total knee arthroplasty. PDPH is defined as a headache that worsens in an upright position and improves while lying down.
Detailed description
This prospective observational study aims to investigate the role of ultrasonographically measured optic nerve sheath diameter (ONSD) in predicting the development and severity of post-dural puncture headache (PDPH) in patients undergoing total knee arthroplasty (TKA) under spinal anesthesia.
The study will include patients aged 18 to 65 years, with American Society of Anesthesiologists (ASA) physical status I or II, who are scheduled to undergo total knee prosthesis (TKP) surgery under spinal anesthesia, with successful administration using a 27G Quincke spinal needle on the first attempt. Exclusion criteria will include a history of central nervous system disorders (e.g., cerebrovascular diseases, intracranial hemorrhage, brain tumors), ophthalmological disorders, hypertension, hepatic encephalopathy, renal failure, pregnancy, history of chronic headache or migraine, obesity (body mass index >35 kg/m²), alcohol or substance dependence, psychiatric disorders, local infection at the injection site, allergy to local anesthetics, bleeding diathesis, requirement for sedation during the procedure, conditions that may impair postoperative cooperation (e.g., mental retardation, language acquisition deficits), and inability to obtain reliable optic nerve sheath diameter (ONSD) measurements.
Ultrasonographic ONSD measurements will be performed using a 7.5 MHz linear ultrasound probe preoperatively (baseline) and at 6, 12, 24, 36, and 48 hours postoperatively. PDPH will be defined as a headache that worsens in the sitting or standing position and improves when lying down. Headache severity will be assessed using the Numerical Rating Scale (NRS), in which patients rate their pain from 0 (no pain) to 10 (the worst pain imaginable). Postoperative pain related to surgery will also be assessed using the NRS, and the need for rescue analgesics will be documented (NRS ≥ 4). Intraoperative vital parameters, including heart rate and arterial blood pressure, will also be monitored. In addition to the incidence and severity of PDPH, associated symptoms (nausea, vomiting, photophobia, diplopia, auditory symptoms, neck pain, and dizziness) will be recorded. Patients who develop PDPH will be assigned to Group H, while those who do not will be assigned to Group C.
The primary aim of this study is to determine the diagnostic and prognostic value of ONSD measurements in predicting PDPH following spinal anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 to 65 years undergoing total knee arthroplasty under spinal anesthesia.
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- ASA physical status I or II
- Scheduled for total knee arthroplasty under spinal anesthesia
- Successful spinal anesthesia with a single attempt using a 27G Quincke spinal needle
- Provided informed consent to participate in the study
Key exclusion criteria (16 listed)
- History of neurological or central nervous system disorders (e.g., cerebrovascular disease, intracranial hemorrhage, brain tumor)
- Ophthalmological disorders
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonographic Measurement of Optic Nerve Sheath Diameter (ONSD)Non-invasive ultrasonographic measurement of optic nerve sheath diameter (ONSD) using a 7.5 MHz linear probe at predefined time points: preoperative and postoperative 6, 12, 24, 36, and 48 hours. | Other | – |
Primary outcome
Incidence of Post-Dural Puncture Headache (PDPH)
Time frame: Within 48 hours postoperatively
The proportion of patients who develop PDPH within the first 48 hours following spinal anesthesia. PDPH will be defined as a headache that worsens in the sitting or standing position and improves when lying down.
5 secondary outcomes
Optic Nerve Sheath Diameter (ONSD) Measurement
Time frame: At baseline (preoperative), and at 6, 12, 24, 36, and 48 hours postoperatively
Severity of Post-Dural Puncture Headache (PDPH)
Time frame: Within 48 hours postoperatively
Symptoms Associated with PDPH
Time frame: Within 48 hours postoperatively
Postoperative Pain
Time frame: Within 48 hours postoperatively
Rescue Analgesic Requirement
Time frame: Within 48 hours postoperatively
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 10 Feb 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Anesthesia, Local and Headache, run by Ankara City Hospital Bilkent 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 16 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 10 Feb 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?
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?
Incidence of Post-Dural Puncture Headache (PDPH) (time frame: Within 48 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 10 Feb 2026.