THE EFFECT OF EPIDURAL ANESTHESIA ON OPTIC NERVE SHEATH DIAMETER MEASUREMENTS IN TOTAL KNEE PROSTHESIS SURGERY WITH NEURAXIAL ANESTHESIA: A PROSPECTIVE RANDOMIZED CONTROLLED STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Optic Nerve Sheath Diameter (ONSD) Changes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-75 years with ASA I-III risk group who were scheduled for total knee replacement and volunteered to participate.
排除标准
- •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.
研究组 & 干预措施
spinal anaesthesia
patients in this group receive spinal anaesthesia at l4-5 interspace using 25 G quincke spinal needle
干预措施: Bupivacaine %0.5 (hyperbaric) (Drug)
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.
干预措施: Bupivacaine %0.25 (isobaric) (Drug)
结局指标
主要结局
Optic Nerve Sheath Diameter (ONSD) Changes
时间窗: 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.
次要结局
- 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).)
研究者
eralp çevikkalp
associate professor
Bursa City Hospital