Total Knee ReplacementNCT07458321
The Effect of Epidural Anesthesia on Optic Nerve Sheath Diameter Measurements in Total Knee Prosthesis Surgery
A study testing Bupivacaine %0.25 (isobaric) and Bupivacaine %0.5 (hyperbaric) in people with Total Knee Replacement and Optic Nerve Sheath Diameter Measurement, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Knee Replacement, Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Change
- What is being tested?
- Bupivacaine %0.25 (isobaric) and Bupivacaine %0.5 (hyperbaric)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Dec 2023to 20 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-75 years with ASA I-III risk group who were scheduled for total knee replacement and volunteered to participate.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF EPIDURAL ANESTHESIA ON OPTIC NERVE SHEATH DIAMETER MEASUREMENTS IN TOTAL KNEE PROSTHESIS SURGERY WITH NEURAXIAL ANESTHESIA: A PROSPECTIVE RANDOMIZED CONTROLLED STUDY
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.
Read the 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.
- Conditions
- Total Knee Replacement, Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Change
- Being tested
- Bupivacaine %0.25 (isobaric), Bupivacaine %0.5 (hyperbaric)
- Keywords
- neuraxial anesthesia, spinal anesthesia, epidural anesthesia, ocular sonography, optic nerve sheath diameter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine %0.25 (isobaric)Drug
in epidural group A total volume of 20 ml of 0.25% bupivacaine is administered into the epidural space.
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.
| Study group | Role | What they receive |
|---|---|---|
| spinal anaesthesia | Active comparator | patients in this group receive spinal anaesthesia at l4-5 interspace using 25 G quincke spinal needle Receives: 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. Receives: Drug: Bupivacaine %0.25 (isobaric) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Monitoring of blood pressure and heart rate to assess the hemodynamic stability of patients during and after neuroaxial anesthesia.
Measured: Baseline (T0), 10 minutes after anesthesia (T1), 40 minutes after tourniquet removal (T2), and 24 hours postoperatively (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start6 Dec 2023
- Primary completion6 Jan 2024
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, eralp çevikkalp, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458321
- Sponsor's protocol ID
- 2023-20/3
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32314244Park 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.
PubMed 38950931Hong 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.
PubMed 34704711
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF EPIDURAL ANESTHESIA ON OPTIC NERVE SHEATH DIAMETER MEASUREMENTS IN TOTAL KNEE PROSTHESIS SURGERY WITH NEURAXIAL ANESTHESIA: A PROSPECTIVE RANDOMIZED CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT07458321
- Acronym / sponsor ID
- 2023-20/3
- Conditions
- Total Knee Replacement, Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Change
- Keywords
- neuraxial anesthesia, spinal anesthesia, epidural anesthesia, ocular sonography, optic nerve sheath diameter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 6 Jan 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal anaesthesia | Active comparator | Drug: Bupivacaine %0.5 (hyperbaric)patients in this group receive spinal anaesthesia at l4-5 interspace using 25 G quincke spinal needle |
| epidural anesthesia | Experimental | Drug: Bupivacaine %0.25 (isobaric)Patients in this group receive epidural anesthesia at the L4-L5 interspace using an 18G Tuohy needle and the loss-of-resistance technique. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 18-75 years with ASA I-III risk group who were scheduled for total knee replacement and volunteered to participate.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine %0.25 (isobaric)in epidural group A total volume of 20 ml of 0.25% bupivacaine is administered into the epidural space. | Drug | epidural anesthesia |
| Bupivacaine %0.5 (hyperbaric)in spinal group A dose of 15 mg (3 ml) of 0.5% heavy bupivacaine is administered into the subarachnoid space. | Drug | spinal anaesthesia |
Primary outcome
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.
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Background: PubMed 32314244Zoerle 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.
- Background: PubMed 38950931Park 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.
- Background: PubMed 34704711Hong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine %0.25 (isobaric) and Bupivacaine %0.5 (hyperbaric) in people with Total Knee Replacement and Optic Nerve Sheath Diameter Measurement, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07458321, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.