Ultrasonographic Optic Nerve Sheath Diameter in Postdural Puncture Headache Diagnosis

NCT07100158 | Completed

• 1 other identifier: ONSD
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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. PDPH is defined as a headache that worsens in an upright position and improves while lying down.

Conditions

Anesthesia, Local; Headache

Keywords

Optic Nerve Sheath Diameter; Post-Dural Puncture Headache; Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 48 hours postoperatively

Secondary Outcomes (5)

• Optic Nerve Sheath Diameter (ONSD) Measurement

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

• Severity of Post-Dural Puncture Headache (PDPH)

  Within 48 hours postoperatively

• Symptoms Associated with PDPH

  Within 48 hours postoperatively

• Postoperative Pain

  Within 48 hours postoperatively

• Rescue Analgesic Requirement

  Within 48 hours postoperatively

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 to 65 years undergoing total knee arthroplasty under spinal anesthesia.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Çankaya, Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Headache; Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation specialist doctor

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 3, 2025
• Study Start: August 8, 2025
• Primary Completion: December 9, 2025
• Study Completion: February 7, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)