Effects of Thoracic Erector Spinae Plane Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS)
试验速览
- 阶段
- 4 期
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Numeric rating scale (NRS)
研究概览
简要总结
This is a prospective randomized study intended to assess the efficacy of erector spinae plane analgesia on acute and chronic postoperative pain for VATS procedures. It will include 72 patients presenting to Severance hospital for a VATS procedure. Patients will be randomized 1:1 to receive either ESP block and intravenous patient-controlled analgesia (IV PCA) or IV PCA only. Ropivacaine will be used in nerve block, and injected at the end of surgery. The primary outcome will be to compare analgesic efficacy between the two groups as defined by immediate postoperative pain scores on the numeric pain rating scale. Secondary outcomes include total opioid consumption, painDETECT score, and chronic pain scores.
详细描述
Postoperative pain control for thoracic surgery is key to allow faster recovery and diminish postoperative complications. Poorly controlled acute pain may contribute to the impairment of respiratory function and the development of chronic post-thoracotomy pain.
Recently, an increasing number of erector spinae plane (ESP) nerve blocks are being performed as it has been demonstrated, and via case reports that the blocks provide clinical effectiveness, but may have a better side-effect profile than the paravertebral nerve block and epidural analgesia. Moreover, there is an advantage for novice because ESP block is simpler and safer to proceed than conventional nerve blocks.
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
Both participants and anesthesia provider will not know which intervention applied. Another anesthesia provider who did not perform nerve block will follow and record to the study data.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female participants providing written informed consent,
- •ASA grade 1-3,
- •aged over 20 and under 80,
- •primary lung cancer participants scheduled segmentectomy or lobectomy c MLND,
- •undergoing a VATS procedure under General Anaesthesia
排除标准
- •Absence of informed written consent,
- •chemotherapy before or after surgery,
- •pre existing infection at block site,
- •severe coagulopathy,
- •pre existing neurological deficit,
- •previous history of opiate abuse,
- •pre existing chronic pain condition,
研究组 & 干预措施
Interventional
Under general anaesthesia, ultrasound guided ESP block will perform at the T5 level with 0.375% ropivacaine 20ml. Fentanyl 1 ug/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with fentanyl (10 ug/kg) and palonosetron 0.075mg will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 48 hours. Pain assessment will record 3 months after surgery.
干预措施: ESP block (Drug)
结局指标
主要结局
Numeric rating scale (NRS)
时间窗: up to postoperative 48 hours.
These scores will record till the postoperative 48 hours. - The Numerical Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
次要结局
- opioid consumption(3 months after surgery.)
- postoperative painDETECT score(up to postoperative 3 months.)
- NRS(up to postoperative 3 months.)