The Efficacy of Serratus Anterior Plane Block in Analgesia for Thoracotomy: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- visual analog scale
研究概览
简要总结
Thoracotomy is considered the most painful surgical procedure. Ultrasound-guided serratus anterior plane block (SAPB) is a relatively new truncal block method treating thoracotomy pain. In this study, investigators aim to ascertain the efficacy of SAPB in thoracotomy.
详细描述
Thoracotomy is considered the most painful surgical procedure, even with thoracic epidural analgesia (TEA) as a golden standard for acute post-thoracotomy pain. Ultrasound-guided serratus anterior plane block (SAPB) is a relatively new truncal block method treating thoracotomy pain, yet more evidence is needed to ascertain its efficacy.
This is a prospective study carried out in a tertiary hospital. Patients scheduled for thoracotomy are randomized into two groups: Group M (intravenous patient-controlled-analgesia morphine) and Group S (intravenous patient-controlled analgesia morphine and SAPB). Morphine consumption, VAS pain score and Prince-Henry pain score are recorded for 72 hours respectively at PACU, 2hr, 6hr, 12hr, 24hr, 48hr and 72hr, with heart rate, systolic pressure, diastolic pressure, mean arterial pressure and SpO2. Moreover, the profile of opioids-related side effects and length of hospital stay are documented. The primary objective of the study is to evaluate the efficacy of SAPB. The secondary objective is to compare the opioids-related side effects (including nausea, vomiting and pruritus), hemodynamic parameters and the length of hospital stay.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 18-28kg/m2
- •Wedge incision and lobectomy
排除标准
- •Uncontrolled hypertension or chronic conditions
- •History of opioid dependence
- •Allergy to bupivacaine hydrochloride
- •Severe bleeding during operation or post operation
- •Inability to communicate with investigators.
研究组 & 干预措施
SAPB group. Group S
In this group, serratus anterior plane block (SAPB) was performed before extubation with injection of 30 ml of 0.25% bupivacaine hydrochloride followed by 0.1ml/kg/hr of 0.12% bupivacaine hydrochloride. In addition to SAPB, intravenous patient-controlled-analgesia morphine was used. Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.
干预措施: Serratus anterior plane block (Procedure)
SAPB group. Group S
In this group, serratus anterior plane block (SAPB) was performed before extubation with injection of 30 ml of 0.25% bupivacaine hydrochloride followed by 0.1ml/kg/hr of 0.12% bupivacaine hydrochloride. In addition to SAPB, intravenous patient-controlled-analgesia morphine was used. Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.
干预措施: Intravenous patient-controlled-analgesia morphine (Drug)
Control group. Group C
In this group, intravenous patient-controlled-analgesia morphine was used. Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.
干预措施: Intravenous patient-controlled-analgesia morphine (Drug)
结局指标
主要结局
visual analog scale
时间窗: Changes at 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
Adult Pain Visual Analog Scale
次要结局
- Catheter-related profile(at Day 1, Day2 and Day 3 post-operation)
- Hemodynamic profile - Heart rate(At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation)
- Hemodynamic profile - blood pressure(At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation)
- Hemodynamic profile - SpO2(At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation)
- Opioids-related side effects - nausea(At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation)
- Morphine consumption(At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation)