The Effect of Epidural Anesthesia on Optic Nerve Sheath Diameter Measurements in Total Knee Prost… (NCT07458321) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Epidural Anesthesia on Optic Nerve Sheath Diameter Measurements in Total Knee Prosthesis Surgery
Turkey (Türkiye)60 participantsStarted 2023-12-06
Plain-language summary
This study investigates the effects of epidural anesthesia on intracranial pressure (ICP) by using ultrasonographic optic nerve sheath diameter (ONSD) measurements as a non-invasive indicator. The study aims to determine if the volume of local anesthetic applied to the epidural space during total knee replacement surgery leads to transient increases in ONSD compared to spinal anesthesia. Participants are randomized into two groups to receive either epidural or spinal anesthesia, and their ONSD measurements are tracked before, during, and after the surgery.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
aged 18-75 years with ASA I-III risk group who were scheduled for total knee replacement and volunteered to participate.
Exclusion Criteria:
Patients with contraindications to regional anesthesia, hypersensitivity to the drugs used, pregnancy, current or past ocular disease/operation history, orbital trauma, optic nerve pathology, glaucoma history; increased intracranial pressure, pseudotumor cerebri, coagulopathy and local infection; and those who refused to participate were excluded.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Optic Nerve Sheath Diameter (ONSD) Changes
Timeframe: Baseline (T0), 10 minutes after anesthesia (T1), 40 minutes after tourniquet removal (T2), and 24 hours postoperatively (T3).