Erector Spinae Plane Block For Analgesia Following Video-Assisted Thoracoscopic Surgery : A Multi-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Postoperative hydromorphone consumption
研究概览
简要总结
Erector spinae (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It is meant to block the ipsilateral trunk. The aim of the study is to demonstrate the efficacy of the ESP block as postoperative analgesia for VATS surgery.
详细描述
A growing number of thoracic surgeries are performed with a minimally invasive approach called video-assisted thoracoscopic surgery (VATS). VATS has reduced the incision size, the postoperative pain and the morbidity associated with thoracic surgery. Optimal postoperative analgesia for VATS surgery remains an open issue because although it is a lot less painful than a thoracotomy, VATS is a painful procedure with the associated risk of developing chronic pain. Adequate relief leads to early mobilization, potentially improves respiratory functions, and decreases the global stress response secondary to the surgery.
Invasive analgesic techniques such as epidural or paravertebral block for VATS surgery are frequently being replaced for less invasive plane blocks to provide postoperative analgesia. At our center, anesthesiologists tend to perform epidurals only when there is a significant risk of transitioning to an open thoracotomy. Patient controlled analgesia (PCA), remains the usual analgesic technique for VATS surgery at our institution.
Erector spinae (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It is meant to block the ipsilateral trunk. The aim of the study is to demonstrate the efficacy of the ESP block as postoperative analgesia for VATS surgery.
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, Investigator)
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 > 18 years old with to ASA status I-III, undergoing VATS for lobectomy or wedge.
- •Non-inclusion Criteria:
- •< 18 years old
- •BMI > 35
- •Chronic pain history with regular opioid and/or gabapentinoids use during the 2 weeks before surgery
- •Regular marijuana use
- •History of thoracic surgery on the operated side
- •Epidural analgesia preferred due to an anticipated high risk of conversion to thoracotomy
- •Unable to communicate with the investigators
- •Receiving anticoagulation or experiencing any bleeding disorder
- •Surgery for empyema and sympathectomy
- •Known allergy to local anesthetics, fentanyl or hydromorphone
- •Active infection at injection sites
- •Preexisting neurological deficit or psychiatric illness
- •Severe cardiovascular disease
- •Liver failure
- •Renal failure (estimated glomerular filtration rate <15 mL/ min/1.73 m2)
- •Pregnancy
排除标准
- •Perioperative conversion to thoracotomy
- •Severe intra- or postoperative bleeding
- •Patients requiring postoperative mechanical ventilation
- •Technical inability to proceed with the blocks
研究组 & 干预措施
ESP with Bupivacaine 0.5%
The Erector Spinae Block (ESP) will be performed using the method described by Forero et al and Hamilton et al. in 2017 by an expert regional anesthesiologist.
Thirty milliliters of bupivacaine at a concentration of 0.5% with epinephrine 1:200 000 will be injected depending on the patient's allocation.
Patient controlled analgesia (PCA) settings for both groups will remain the same: hydromorphone with a bolus of 0,2 mg, lockout time of 5 minutes and no background infusion. The PCA will be started when the patient is transferred to the postanesthesia care unit (PACU).
干预措施: ESP with Bupivacaine 0.5% (Procedure)
ESP with Saline 0.9%
The Erector Spinae Block (ESP) will be performed using the method described by Forero et al and Hamilton et al. in 2017 by an expert regional anesthesiologist.
Thirty milliliters of a placebo solution (normal saline) will be injected depending on the patient's allocation.
Patient controlled analgesia (PCA) settings for both groups will remain the same: hydromorphone with a bolus of 0,2 mg, lockout time of 5 minutes and no background infusion. The PCA will be started when the patient is transferred to the postanesthesia care unit (PACU).
干预措施: ESP with Saline 0.9% (Procedure)
结局指标
主要结局
Postoperative hydromorphone consumption
时间窗: 24 hours.
Using the Patient-Controlled Analgesia pumps, we will be able to calculate the amount of Hydromorphone that will be consumed by patients in each of our intervention arms.
次要结局
- Thorax visual analog pain scores (VAS) : scale 0 (no pain) to 10 (worst)(1-6-12-18-24 hours.)
- Total opioid consumption post-surgery(1-6-12-18-24 hours.)
- PONV Score : 1 to 3 (1- No nausea, 2- Nausea, 3- Vomiting)(1-6-12-18-24 hours.)
- Ramsay Sedation Scale (RSS) 1 to 6 (1- Awake and Agitated, 2- Awake but calm to 6- Asleep and no response to loud auditory stimulus)(1-6-12-18-24 hours.)
- Global QoR-15 score : 0 to 150 (worst to best)(Pre and postoperatively)
- Amount of intraoperative Fentanyl use(Intraoperatively)
研究者
Ariane Clairoux
Assistant Professor Anesthesiology and Pain Medicine
Ciusss de L'Est de l'Île de Montréal