Comparison of the Efficacy of Quadro Iliac Plane Block and Erector Spinae Plane Block on Postoperative Pain Management and Opioid Consumption in Single Level Lumbar Discectomies: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- NRS Score
研究概览
简要总结
This multicenter, randomized, controlled study aims to compare the analgesic efficacy of Quadro Iliac Plane Block (QIPB) and Erector Spinae Plane (ESP) Block in lumbar vertebra surgeries. The study will evaluate postoperative pain management, opioid consumption, side effects, hospital stay duration, and patient satisfaction. Patients scheduled for single-level lumbar disk herniation surgery will be randomized to receive either the QIPB or ESP block before awakening from anesthesia. Pain scores will be measured at multiple postoperative time points, and opioid consumption will be monitored using patient-controlled analgesia (PCA). The study seeks to identify the most effective and safe method for postoperative pain management in lumbar surgeries.
详细描述
Detailed Description: The purpose of this study is to compare the analgesic efficacy of two commonly used regional anesthesia techniques-Quadro Iliac Plane Block (QIPB) and Erector Spinae Plane (ESP) Block-in lumbar vertebra surgeries. This is a prospective, randomized, controlled, and multicenter trial. The study aims to evaluate the effectiveness of QIPB and ESP blocks in postoperative pain control, opioid consumption, side effects, hospital stay duration, and patient satisfaction. The findings are expected to contribute to identifying more effective and safer methods for postoperative pain management in lumbar spine surgeries.
This study will focus on examining the impact of these two different block techniques on pain scores, particularly during the early postoperative period. By analyzing the potential benefits and limitations of these techniques, the study will aim to provide valuable insights into postoperative pain control. Additionally, a comparative analysis of the feasibility and patient safety of both block techniques will be conducted.
Materials and Methods: Patients aged 18 and above, with ASA scores of I-III, without bleeding diathesis, no history of anticoagulant use, no history of allergies to the medications used, and no history of neuropathic disease, undergoing single-level lumbar disk herniation surgery will be included in the study. Patients will be randomized to receive either ESP or QIP block before awakening post-surgery. Informed consent will be obtained from all participants, and both blocks will be thoroughly explained.
To avoid bias, the study is designed as multicenter, and experienced anesthesiologists will perform the blocks at the end of the surgery, before the patient is awakened.
Block Techniques:
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
This study employs a Double-Blind masking approach to minimize bias. Both the patients and the healthcare providers (including postoperative care staff) will be unaware of which block (Quadro Iliac Plane Block or Erector Spinae Plane Block) was administered. The anesthesiologists performing the blocks will be informed of the assigned intervention but will not participate in postoperative care or outcome assessment. The outcome assessors, who will evaluate pain scores, opioid consumption, and other outcomes, will also be blinded to the group allocation to ensure unbiased data collection.
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
- •Patients aged 18 to 65 years.
- •ASA physical status classification I-III.
- •Patients scheduled for single-level lumbar disk herniation surgery.
- •No history of bleeding diathesis.
- •No history of anticoagulant use.
- •No known allergies to the medications used in the study (e.g., bupivacaine).
- •No history of neuropathic diseases.
- •Patients who have provided informed consent to participate in the study.
排除标准
- •Patients younger than 18 or older than 65 years.
- •ASA physical status classification IV or higher.
- •Patients with a history of coagulopathy or bleeding disorders.
- •Patients with a history of chronic opioid use or substance abuse.
- •Patients with allergies to local anesthetics (e.g., bupivacaine).
- •Patients with significant neuropathic conditions or central nervous system disorders.
- •Patients with any contraindication to regional anesthesia.
- •Pregnant or breastfeeding women.
- •Patients unable to provide informed consent.
结局指标
主要结局
NRS Score
时间窗: 24 hours
Postoperative pain assessed by numerical rating scale (NRS) (0-10)
次要结局
- PCA(24 hours)
- Rescue analgesia(24 hours)
- Side effects(24 hours)
研究者
Engin Ihsan Turan
anesthesiology and reanimation specialist
Kanuni Sultan Suleyman Training and Research Hospital