Comparison Of Postoperative Analgesic Efficacy Using Analgesia Nociception Index Monitoring In Patients Undergoing Elective Lumbar Spine Surgery: A Randomized Parallel-Group Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Analgesia Nociception Index (ANI)
研究概览
简要总结
This study aims to compare two different pain management methods in patients undergoing elective lumbar spine surgery. Patients are randomly assigned to receive either an ultrasound-guided erector spinae plane block (ESPB) or intravenous multimodal analgesia.
Postoperative pain will be assessed using both clinical pain scores and the Analgesia Nociception Index (ANI), a non-invasive monitoring system that evaluates pain-related responses based on heart rate variability. The goal of this study is to determine which method provides better postoperative pain control.
详细描述
Effective postoperative pain management is essential in lumbar spine surgery to improve patient comfort and recovery. Traditional pain assessment methods rely on subjective scales, such as the Visual Analog Scale (VAS). The Analgesia Nociception Index (ANI) is a non-invasive monitoring tool based on heart rate variability analysis that provides an objective assessment of the balance between nociception and analgesia.
This randomized parallel-group clinical study compares two analgesic strategies in adult patients undergoing elective lumbar spine surgery. Participants are randomly assigned using a simple lottery method to receive either ultrasound-guided bilateral erector spinae plane block (ESPB) or intravenous multimodal analgesia.
ANI values are recorded at postoperative 0, 15, 30, 45, 60, 90, 120, and 180. minutes, and at 6, 12, and 24. hours. These measurements are evaluated together with clinical pain scores, total opioid consumption within 24 hours, hemodynamic parameters, and adverse events.
The primary objective is to compare ANI values between the two groups during the early postoperative period. Secondary objectives include comparison of VAS scores, opioid requirements, and incidence of analgesia-related adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •ASA physical status I-II
- •Scheduled for elective lumbar spine surgery
- •Ability to provide informed consent
排除标准
- •Known allergy to study medications
- •Coagulation disorders
- •Infection at the block site
- •Severe cardiovascular disease
- •Pregnancy
- •Inability to understand the study protocol
研究组 & 干预措施
Erector Spinae Plane Block
Ultrasound-guided bilateral erector spinae plane block performed at the thoracolumbar level using a total of 200 mg bupivacaine for postoperative analgesia.
干预措施: Erector Spinae Plane Block (Procedure)
Intravenous Multimodal Analgesia
Intravenous multimodal analgesia including paracetamol 1 g, morphine 0.1 mg/kg, dexamethasone 8 mg, and ketamine 0.5 mg/kg bolus followed by 0.3 mg/kg/h infusion.
干预措施: Intravenous Multimodal Analgesia (Drug)
结局指标
主要结局
Analgesia Nociception Index (ANI)
时间窗: From 0 minutes to 24 hours postoperatively
Analgesia Nociception Index (ANI) measured using the ANI monitor. The ANI ranges from 0 to 100. Higher values indicate greater parasympathetic tone and lower nociceptive stimulation, whereas lower values indicate higher nociceptive stimulation.
次要结局
- Visual Analog Scale (VAS) Pain Score(From 0 minutes to 24 hours postoperatively)
- Postoperative Nausea(Within 24 hours postoperatively.)
研究者
Ayşe Tekin
Research Assistant, Department of Anesthesiology
Akdeniz University Hospital