The Effects of Thoracic Nerve Blocks on Postoperative Pain, Respiratory Function and Recovery in Patients Undergoing Thoracoscopic Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 主要终点
- Efficacy of ESP block in decreasing postoperative pain intensity
研究概览
简要总结
This study aims to study the analgesic and respiratory effects of the erector spinae plane block for patients undergoing video-assisted thoracic surgery (VATS) or robotic assisted thoracic surgery (RATS).
详细描述
A total of 120 subjects will be randomized into three groups (30 per group). Arm A: IV PCIA Arm B: IV PCIA + ultrasound guided Erector spinae block (ESPB, Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine]) Arm C: IV PCIA + multilevel intra-thoracic intercostal nerve block (ICB, Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine]) PCIA pumps for all study cohorts will be programmed according to our institution's standard protocol (Dipidolor [Piritramide] bolus: 2mg, interval: 7 min, max 4h dose: 30mg). The erector spinae block will be placed preoperatively, the intercostal block will be placed at the beginning of the procedure. All patients will receive standard postoperative care. The patients will be blinded for the study arm.
The primary endpoint of this study is postoperative pain and will be recorded by using the numerical rating scale (NRS) pain score. Pain scores will be measured by the investigator at rest and during coughing. Opioid consumption will be monitored and registered for.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients
- •age between 18 to 100 years old
- •scheduled for VATS
- •informed consent explained and signed
排除标准
- •Patients < 18 years old, > 100 years old
- •ASA physical status > 3
- •previous cardiac surgery or ipsilateral thoracic surgery
- •neuropsychiatric diseases
- •allergy to analgesics or local anesthetics or other medications used in the study
- •abuse of opioids or sedatives
- •contraindication to receive regional anesthesia (e.g. coagulation defect)
- •patients who could not understand the VAS pain-scoring system
- •patient refusal to follow participation
- •expected post operative mechanical ventilation
- •intolerance or allergy to any prescribed medication
研究组 & 干预措施
ESP block arm
ultrasound guided Erector spinae block (Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine])
干预措施: Erector spinae plane block with ropivacaine 3.75mg/ml (Drug)
IC block arm
3 ml of 0.5% solution of Naropin [Ropivacaine] per intercostal space, up to a maximum of 30ml
干预措施: Erector spinae plane block with ropivacaine 3.75mg/ml (Drug)
结局指标
主要结局
Efficacy of ESP block in decreasing postoperative pain intensity
时间窗: 48 hours
Pain levels will be assessed using the 10 points Visual analogue Scale (VAS) where zero= no pain and 10= pain as bad as it can be. The vaS is a validated tool to measure pain and discomfort. It is sensitive to pharmacological and non-pharmacological interventions, that have an impact over the experience of pain, as well as it's high correlation with pain levels
次要结局
未报告次要终点