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Completed

NCT Number: NCT07100158

Ultrasonographic Optic Nerve Sheath Diameter in Postdural Puncture Headache Diagnosis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Çankaya, Ankara, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • History of neurological or central nervous system disorders (e.g., cerebrovascular disease, intracranial hemorrhage, brain tumor)
  • Ophthalmological disorders
  • Hypertension
  • Hepatic encephalopathy
  • Renal failure
  • Pregnancy
  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Optic Nerve Sheath Diameter (ONSD) Measurement

    Time frame: At baseline (preoperative), and at 6, 12, 24, 36, and 48 hours postoperatively

    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.

  2. Severity of Post-Dural Puncture Headache (PDPH)

    Time frame: Within 48 hours postoperatively

    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.

  3. Symptoms Associated with PDPH

    Time frame: Within 48 hours postoperatively

    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

  4. Postoperative Pain

    Time frame: Within 48 hours postoperatively

    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.

  5. Rescue Analgesic Requirement

    Time frame: Within 48 hours postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

The Diagnostic Value of Ultrasonographic Optic Nerve Sheath Diameter Measurement in Postdural Puncture Headache

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 3, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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