Effect of Erector Spinae Plane Block on Postoperative Pain Intensity in Patients Undergoing Thoracoscopic Surgery: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain intensity (NRS) 4 hours after surgery.
研究概览
简要总结
This randomized clinical trial compares the effects of the erector spinae plane block with levobupivacaine and 0,9% saline on postoperative pain intensity, and opioid consumptions following thoracoscopic pulmonary surgery.
详细描述
Sixty patients planned for thoracoscopic pulmonary surgery are randomly assigned to an erector spinae plane block (ESPB) with levobupivacaine (intervention group) or 0,9% saline (control group). ESPB is performed under general anaesthesia before surgery.
Postoperative pain medication incudes acetominophen, NSAIDs en parenteral morphine (patient controlled analgesia).
Following surgery pain intensity (numeric rating scale) is registered at the recovery ward one hour after surgery. Furthermore, pain intensity is registered 2,4,8, 12 hours after the operation. On the first postoperative day, pain intensity is registered at 8.00 o'cock AM and 8.00 o'clock PM. Opioid consumption is registered as a second parameter of postoperative pain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for thoracoscopic pulmonary sleeve resection or lobectomy
- •Age 18 years or older
- •American Society of Anesthesiologists (ASA) health status class I-III
- •Informed consent
排除标准
- •Contraindication for regional analgesia (e.g. coagulopathy, infection at injection site)
- •Contraindication for NSAIDs
- •Chronic opioid use
- •Pregnancy
结局指标
主要结局
Pain intensity (NRS) 4 hours after surgery.
时间窗: 4 hours postoperatively
Pain level 4 hours after surgery
Pain intensity (numeric rating scale (NRS) (0=no pain up to 10=most pain imaginable) 2 hours after surgery.
时间窗: 2 hours postoperatively
Pain level 2 hours after surgery
Pain intensity (NRS) 8 hours after surgery.
时间窗: 8 hours postoperatively
Pain level 8 hours after surgery
Pain intensity (NRS) 12 hours after surgery.
时间窗: 12 hours postoperatively
Pain level twelve hours after surgery
次要结局
- Patient satisfaction of pain therapy(Measurement in the morning of the second postoperative day)
- Pain intensity (NRS) at 8.00 o'clock on the first postoperative day(At 8 o'clock AM on the first postoperative day)
- Pain intensity (NRS) at 20.00 o'clock on the first postoperative day(At 8 o'clock PM on the first postoperative day)
- length of stay in recovery ward (minutes)(First 48 hours after surgery)
- Presence of side effects(First 48 hours)
- Opioid consumption(First 48 hours after surgery, recorded following disconnection of the PCA device at 8 o'clock AM on the second postoperative day.)
研究者
Leon Timmerman
MD, PhD
St. Antonius Hospital