Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT07100158
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasonographic Optic Nerve Sheath Diameter in Postdural Puncture Headache Diagnosis
Sponsor:
Ankara City Hospital Bilkent
Organization:
Study Overview
Official Title:
The Diagnostic Value of Ultrasonographic Optic Nerve Sheath Diameter Measurement in Postdural Puncture Headache
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: