Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia After Thoracotomy: A Randomized Controlled Assessor-blinded Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Maximum postoperative pain score at rest on postoperative day 1
研究概览
简要总结
This prospective, randomized, assessor-blinded study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided continuous erector spinae plane (ESP) block in patients undergoing thoracotomy. We hypothesize that US-guided ESP block is not inferior to thoracic epidural analgesia in terms of postoperative pain control in these patients.
详细描述
Adult patients undergoing elective unilateral thoracotomy for lung cancer resection are randomly allocated to receive US-guided ESP block (n=31) or thoracic epidural analgesia (n=31). Both procedures are performed prior to surgery. Each patient was assessed by a blinded investigator on postoperative day (POD) 1,2 and 3. The primary outcome is pain severity evaluated by a numeric rating scale (NRS) at POD1.
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
- Single (Outcomes Assessor)
盲法说明
The outcome assessor not involved in this study will investigate the outcomes.
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 to undergo elective thoracotomy for lung cancer
- •European Cooperative Oncology Group 0 or 1
- •American Society of Anesthesiologists (ASA) physical classification I-III
- •Willingness and ability to sign an informed consent document
排除标准
- •patients with chronic postoperative pain after thoracic surgery
- •patients undergoing thoracotomy with chest wall resection
- •allergies to anesthetic or analgesic medications
- •patients with coagulopathy or who continue to take anticoagulants
- •preoperative liver or renal dysfunction
- •patients with chronic pain, chronic opioid, analgesic or antidepressant or anticonvulsant use
- •Do not understand our study
- •Medical or psychological disease that can affect the treatment response
结局指标
主要结局
Maximum postoperative pain score at rest on postoperative day 1
时间窗: Maximum pain score among the 9 am and 4 pm measurements on postoperative day 1
pain score measured by the 11-pointed numeric rating scale (0: none/10: worst pain)
次要结局
- Change in the total consumption (ml) of patient-controlled analgesia(9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on postoperative day 3)
- Postoperative pulmonary function test(3 months after surgery)
- Change in the quality of recovery-15 scale from baseline to postoperative day 3(Day before surgery and 4pm on postoperative day 3)
- Postoperative pain score at rest(9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on postoperative day 3)
- Incidence of chronic postoperative pain(6 months after surgery)
- Postoperative pain score at movement(9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on postoperative day 3)
研究者
Susie Yoon
Assistant clinical professor
Seoul National University Hospital