Comparison of Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Intra and Postoperative Pain Control in Modified Radical Mastectomy: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Post-operative pain assessment
研究概览
简要总结
The aim of the study is to compare the effectiveness of the Erector spinae plane (ESP) block versus thoracic paravertebral (TPV) block in the post-operative pain control after radical mastectomy.
详细描述
Primary outcome of our study is to compare the effectiveness of two regional anesthesia techniques, ESP block and TPV block, in the post-operative pain-control after radical mastectomy.
We will also evaluate both intra and post-operative opioid consumption, the incidence of PONV, the length of hospital stay, patient satisfaction with the anesthesiology technique and the incidence of chronic pain 6 months after surgery.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 85
- •American Society of Anesthesiologists classification I - III
- •Signature of consent to participate in the study
排除标准
- •Coagulopathies and / or use of antiplatelet / anticoagulant drugs
- •Infections and/or lesions at the puncture site,
- •allergies and / or contraindications to the administration of the drugs used in the study,
- •use of chronic opioid therapy
结局指标
主要结局
Post-operative pain assessment
时间窗: 12 hours
post-operative pain assessment using Numeric rating scale (from 0,no pain, to 10 ,worst pain)
次要结局
- Length of hospital stay(3 days)
- Evaluate the incidence and severity of persistent pain 6 months after surgery(six months)
- Incidence of PONV(36 hours)
- Opioid use(36 hours)
- Assessment of patient satisfaction with the anesthesiological technique(36 hours)