NCT07458321

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

March 4, 2026

Last Update Submit

March 4, 2026

Conditions

Total Knee ReplacementOptic Nerve Sheath Diameter MeasurementIntracranial Pressure Change

Keywords

neuraxial anesthesiaspinal anesthesiaepidural anesthesiaocular sonographyoptic nerve sheath diameter

Outcome Measures

Primary Outcomes (1)

  • Optic Nerve Sheath Diameter (ONSD) Changes

    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 Outcomes (1)

  • Mean Arterial Pressure (MAP) and Heart Rate (HR)

    Baseline (T0), 10 minutes after anesthesia (T1), 40 minutes after tourniquet removal (T2), and 24 hours postoperatively (T3).

Study Arms (2)

spinal anaesthesia

ACTIVE COMPARATOR

patients in this group receive spinal anaesthesia at l4-5 interspace using 25 G quincke spinal needle

Drug: Bupivacaine %0.5 (hyperbaric)

epidural anesthesia

EXPERIMENTAL

Patients in this group receive epidural anesthesia at the L4-L5 interspace using an 18G Tuohy needle and the loss-of-resistance technique.

Drug: Bupivacaine %0.25 (isobaric)

Interventions

Bupivacaine %0.25 (isobaric)DRUG

in epidural group A total volume of 20 ml of 0.25% bupivacaine is administered into the epidural space.

epidural anesthesia
Bupivacaine %0.5 (hyperbaric)DRUG

in spinal group A dose of 15 mg (3 ml) of 0.5% heavy bupivacaine is administered into the subarachnoid space.

spinal anaesthesia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18-75 years with ASA I-III risk group who were scheduled for total knee replacement and volunteered to participate.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa City Hospital

Bursa, Merkez, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 32314244BACKGROUND

  • 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.

    PMID: 38950931BACKGROUND

  • 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.

    PMID: 34704711BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 9, 2026

Study Start

December 6, 2023

Primary Completion

January 6, 2024

Study Completion

April 20, 2024

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)