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Clinical Trials/NCT06957899
NCT06957899CompletedNot Applicable

Impact of Spinal Needle Gauge on Optic Nerve Sheath Diameter in Patients With Post-Dural Puncture Headache

Konya City Hospital1 site in 1 country40 target enrollmentStarted: July 1, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Optic nerve sheath diameter (ONSD)

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Optic nerve sheath diameter (ONSD)

Time Frame: Within 4 hours of anesthesia consultation for postoperative headache

The primary outcome is the measurement of optic nerve sheath diameter (ONSD) via ocular ultrasound in patients who develop postoperative headache attributed to dural puncture. This non-invasive assessment is used to estimate intracranial pressure. The aim is to evaluate whether different spinal needle gauges affect ONSD measurements.

Secondary Outcomes

  • Pain severity assessed by Visual Analog Scale (VAS)(Within 4 hours of anesthesia consultation for postoperative headache)

Investigators

Sponsor
Konya City Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nuran Akıncı Ekinci

MD, Specialist in Anesthesiology

Konya City Hospital

Study Sites (1)

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