Analgesic Efficacy of Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in Video- Assisted Thoracoscopy (VATS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- pain score on numerical rating score
研究概览
简要总结
The goal of this clinical trial is to compare analgesic efficacy of erector spinae plane (ESP) block vs intravenous lignocaine infusion in video- assisted thoracoscopy (VATS. The main goals are to compare post- operative pain scores and cumulative post- operative opioid doses in both groups
详细描述
Number of patients: 60 patients enrolled for VATS procedure randomly and evenly assigned to one of the 2 groups.
Randomization: An online tool (Sealed EnvelopeTM[12]) will be used to randomly and evenly assign patients to one of the two groups. Blocks of 4,6,8 will be used and since the blocks assignment will be random as well, the total number of patients can be slightly larger than 60. On the day of the procedure an envelope containing one block of numbers will be opened and numbers from that envelope will be drawn for consecutive patients until the block is finished.
Intervention:
under general anaesthesia, preoperative ultrasound(USG) guided ESP blockade at Th5, single shot of 30 ml 0,3 % bupivacaine (not exceeding the maximum dose of 2 mg/kg of bupivacaine) with adrenaline 5 µg/ml and dexamethasone 0,15 mg/kg intravenously, post-operative infusion of 0,9% NaCl for 6 hours, infusion rate set as if it were lignocaine 1,5 mg/kg/h vs pre-induction lignocaine bolus of 1,5 mg/kg i.v. and dexamethasone 0,15 mg/kg intravenously, intraoperative infusion of lignocaine 2 mg/kg i.v., post-operative infusion of lignocaine 1,5 mg/kg i.v. for 6 hours
Patient and nursing staff will be blinded to the performed intervention.
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, Care Provider)
盲法说明
Patient and nursing staff will be blinded to the performed intervention. PI and performing anaesthesiologist will not be blinded.
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
- •VATS for tumor resection or partial lung resection in emphysema
- •Written, informed consent obtained 1 day prior to surgery
排除标准
- •Lack of consent for ESP blockade
- •History of allergy to local anaesthetics
- •Other contraindications to ESP blockade
- •American Society of Anesthesiologists(ASA) Physical Status Classification value 4 or higher
- •VATS for indications other than tumor resection or partial lung resection in emphysema
- •Insulin- dependent diabetes mellitus
- •More than 1 chest drain post-operatively
- •Conversion to thoracotomy
- •Chronic opioid use prior to surgery defined as opioid administration for at least 3 months during the last 12 months
- •History of alcohol abuse
- •Suspected technical difficulties with performing the ESP block (e.g. obesity)
- •Inadequate spread of the local anaesthetic during the ESP block
- •Cognitive impairment that might cause an inaccurate assessment of pain levels
研究组 & 干预措施
ESP block group
under general anaesthesia, preoperative ultrasound(USG) guided ESP blockade at Th5, single shot of 30 ml 0,3 % bupivacaine (not exceeding the maximum dose of 2 mg/kg of bupivacaine) with adrenaline 5 µg/ml and dexamethasone 0,15 mg/kg intravenously, post-operative infusion of 0,9% NaCl for 6 hours, infusion rate set as if it were lignocaine 1,5 mg/kg/h
干预措施: Erector Spinae Plane (ESP) block (Procedure)
ESP block group
under general anaesthesia, preoperative ultrasound(USG) guided ESP blockade at Th5, single shot of 30 ml 0,3 % bupivacaine (not exceeding the maximum dose of 2 mg/kg of bupivacaine) with adrenaline 5 µg/ml and dexamethasone 0,15 mg/kg intravenously, post-operative infusion of 0,9% NaCl for 6 hours, infusion rate set as if it were lignocaine 1,5 mg/kg/h
干预措施: Bupivacaine (Drug)
Lignocaine infusion group
pre-induction lignocaine bolus of 1,5 mg/kg i.v. and dexamethasone 0,15 mg/kg intravenously, intraoperative infusion of lignocaine 2 mg/kg i.v., post-operative infusion of lignocaine 1,5 mg/kg i.v. for 6 hours
干预措施: Lignocaine (Drug)
结局指标
主要结局
pain score on numerical rating score
时间窗: 1,3,6,12 hours after surgery (and on discharge from post- anaesthesia care unit [PACU]/after 24 hours- whichever comes sooner)
static and dynamic score (defined as cough effort) on numerical rating score (values: 0-10 where the lower number means less pain and a better outcome)
cumulative opioid dose
时间窗: 12 hours after the end of the surgery (and on discharge from PACU/after 24 hours- whichever comes sooner)
measured as fentanyl equivalent
次要结局
- incidence of severe hypotension(BP measured at 1,3,6,12 hour and on discharge from PACU or more frequently if needed)
- incidence of nausea and vomiting(anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner)
- incidence of priuritis(anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner)
- incidence of local anaesthetic systemic toxicity symptoms(anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner)
- intra-operative cumulative opioid dose(intra-operative)
- time to discharge from hospital(max. observation time: 30 days)
研究者
Antoni Okniński
Principal Investigator
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland