Clinical trial NCT06957899: Optic Nerve Sheath Diameter in Postspinal Headache
Official title: Impact of Spinal Needle Gauge on Optic Nerve Sheath Diameter in Patients With Post-Dural Puncture Headache
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Post-Dural Puncture Headache
Keywords: Post-Dural Puncture Headache (PDPH)
Intracranial Hypotension
Spinal Anesthesia Complication
Optic Nerve Sheath Diameter
Spinal Needle Gauge
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Presence of neurological or ophthalmological disorders
* History of head trauma within the past 6 months
* Hypertension
* Hepatic encephalopathy
* Renal failure
* Pregnancy
* 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

Primary outcomes:
measure: Optic nerve sheath diameter (ONSD)
timeFrame: Within 4 hours of anesthesia consultation for postoperative headache
Secondary outcomes:
measure: Pain severity assessed by Visual Analog Scale (VAS)
timeFrame: Within 4 hours of anesthesia consultation for postoperative headache
Other outcomes:
measure: Spinal Needle Gauge
timeFrame: Retrieved from procedure documentation at the time of spinal anesthesia
Locations:
city: Meram
country: Turkey
facility: Konya City Hospital
state: Konya
Study officials:
affiliation: Konya City Hospiital
name: Nuran AKINCI EKİNCİ
role: STUDY_CHAIR
References:
citation: 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.
citation: Dubost 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.