The Effect of Epidural Anesthesia on Optic Nerve Sheath Diameter Measurements in Total Knee Prosthesis Surgery
THE EFFECT OF EPIDURAL ANESTHESIA ON OPTIC NERVE SHEATH DIAMETER MEASUREMENTS IN TOTAL KNEE PROSTHESIS SURGERY WITH NEURAXIAL ANESTHESIA: A PROSPECTIVE RANDOMIZED CONTROLLED STUDY
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Neuroaxial techniques like spinal or epidural anesthesia are gold standards for lower extremity surgeries. However, injecting local anesthetics into the epidural space can compress the dural sac, potentially causing a cranial displacement of cerebrospinal fluid (CSF) and a subsequent increase in intracranial pressure (ICP). Since the optic nerve is surrounded by CSF, ONSD measurement serves as a reliable non-invasive surrogate for monitoring these pressure changes.
In this prospective randomized study, 60 patients (ASA I-III) undergoing total knee prosthesis surgery are assigned to one of two groups:
Group 1 (Spinal Anesthesia): Patients receive 15 mg of 0.5% heavy bupivacaine at the L4-L5 level.
Group 2 (Epidural Anesthesia): Patients receive 20 cc of 0.25% bupivacaine at the L4-L5 level.
ONSD measurements are recorded at four specific time points: before anesthesia (t0), 10 minutes after anesthetic onset (t1), 40 minutes after tourniquet removal (t2), and 24 hours postoperatively (t3). The study also monitors secondary outcomes, including postoperative complications and clinical safety profiles related to ICP changes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merkez
-
Bursa, Merkez, Turkey (Türkiye)
- Bursa City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: spinal anaesthesia
patients in this group receive spinal anaesthesia at l4-5 interspace using 25 G quincke spinal needle
|
in spinal group A dose of 15 mg (3 ml) of 0.5% heavy bupivacaine is administered into the subarachnoid space.
|
|
Experimental: epidural anesthesia
Patients in this group receive epidural anesthesia at the L4-L5 interspace using an 18G Tuohy needle and the loss-of-resistance technique.
|
in epidural group A total volume of 20 ml of 0.25% bupivacaine is administered into the epidural space.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Optic Nerve Sheath Diameter (ONSD) Changes
Time Frame: Baseline (T0), 10 minutes after anesthesia (T1), 40 minutes after tourniquet removal (T2), and 24 hours postoperatively (T3).
|
Ultrasonographic measurement of the optic nerve sheath diameter (in millimeters) to evaluate indirect changes in intracranial pressure.
Measurements are taken 3 mm behind the globe using a 7.5-12 MHz linear probe.
|
Baseline (T0), 10 minutes after anesthesia (T1), 40 minutes after tourniquet removal (T2), and 24 hours postoperatively (T3).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Arterial Pressure (MAP) and Heart Rate (HR)
Time Frame: Baseline (T0), 10 minutes after anesthesia (T1), 40 minutes after tourniquet removal (T2), and 24 hours postoperatively (T3).
|
Monitoring of blood pressure and heart rate to assess the hemodynamic stability of patients during and after neuroaxial anesthesia.
|
Baseline (T0), 10 minutes after anesthesia (T1), 40 minutes after tourniquet removal (T2), and 24 hours postoperatively (T3).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Zoerle T, Caccioppola A, D'Angelo E, Carbonara M, Conte G, Avignone S, Zanier ER, Birg T, Ortolano F, Triulzi F, Stocchetti N. Optic Nerve Sheath Diameter is not Related to Intracranial Pressure in Subarachnoid Hemorrhage Patients. Neurocrit Care. 2020 Oct;33(2):491-498. doi: 10.1007/s12028-020-00970-y.
- Park SK, Kim H, Kim Y, Jang YE, Kim JT. Effect of epidural anesthesia on the optic nerve sheath diameter in patients with pre-eclampsia: a prospective observational study. Reg Anesth Pain Med. 2025 Oct 6;50(10):828-834. doi: 10.1136/rapm-2024-105444.
- Hong J, Kim JS, Lee YH. The Effect of Normal Saline Injection Volumes on the Optic Nerve Sheath Diameter during Thoracic Epidural Analgesia. Pain Physician. 2021 Nov;24(7):E1007-E1013.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2023-20/3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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