Ultrasound Guided PECs II (Pectoralis and Serratus Nerves) Block in Patients Undergoing a Thoracic Surgery
试验速览
- 阶段
- 2 期
- 入组人数
- 168
- 主要终点
- Comparison Visual Analog Score between groups
研究概览
简要总结
A new conceptual regional anesthesia the PECs II block (modified pectoral and serratus nerves block) has been described for pain control after thoracic surgery, one of the indications to perform this method is analgesia for surgeries or procedures involving lateral chest wall
详细描述
The PECs I block was found to be very effective after breast cancer surgery and sub-pectoral prosthesis for pain control management.
This block is provided by injection into another myofascial plane, this time between pectoralis minor and serratus anterior muscle at the level of 3rd and 4th rib.PECs II block is simple in performance with a high success rate and minimal incidence of complications, especially, if used ultrasound approach that gives a good understanding of anatomy of the lateral thoracic wall.
In present clinical trial we are going to compare PECs block for pain control with traditional pain management techniques based on IV opioids and NSAIDs treatment in patient undergoing thoracic surgery in early postoperative period.
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
- Double (Investigator, Outcomes Assessor)
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
- •All patients undergoing thoracic surgery, older ≥18 years
- •Patients who meet criteria of ASA I-II-III class.
排除标准
- •Patients who will be unconscious or mentally incompetent
- •Patients refusal to participate in the study
- •Patient with coagulopathy
- •Hemodynamically unstable (systolic BP < 90, HR > 100)
- •Allergy to local anesthetic drugs or opioids
- •Pregnant patient
- •History of opioid abuse
研究组 & 干预措施
Pectoralic block group
After general anesthesia, 40ml of 0.25% Bupivacaine Hydrochloride will be administered before procedure Thoracotomy. Block will be administrated between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib., in assistance of ultrasound for visualization anesthetic injection point.
干预措施: Bupivacaine Hydrochloride (Drug)
Pectoralic block group
After general anesthesia, 40ml of 0.25% Bupivacaine Hydrochloride will be administered before procedure Thoracotomy. Block will be administrated between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib., in assistance of ultrasound for visualization anesthetic injection point.
干预措施: Ultrasound (Device)
Pectoralic block group
After general anesthesia, 40ml of 0.25% Bupivacaine Hydrochloride will be administered before procedure Thoracotomy. Block will be administrated between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib., in assistance of ultrasound for visualization anesthetic injection point.
干预措施: Thoracotomy (Procedure)
Pectoralic block group
After general anesthesia, 40ml of 0.25% Bupivacaine Hydrochloride will be administered before procedure Thoracotomy. Block will be administrated between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib., in assistance of ultrasound for visualization anesthetic injection point.
干预措施: Opioids (Drug)
Pectoralic block group
After general anesthesia, 40ml of 0.25% Bupivacaine Hydrochloride will be administered before procedure Thoracotomy. Block will be administrated between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib., in assistance of ultrasound for visualization anesthetic injection point.
干预措施: NSAID (Drug)
Control group
Patients in this group will receive standard pain control with opioids and NSAIDs
干预措施: Thoracotomy (Procedure)
Control group
Patients in this group will receive standard pain control with opioids and NSAIDs
干预措施: Opioids (Drug)
Control group
Patients in this group will receive standard pain control with opioids and NSAIDs
干预措施: NSAID (Drug)
结局指标
主要结局
Comparison Visual Analog Score between groups
时间窗: First 24 hours from the surgery
First VAS after admission in PACU
次要结局
- Total NSAIDs dosage (mg) in the PACU and department(First 24 hours from the surgery)
- Length of hospital stay(up to 21 days)
- Total morphine dosage (mg) in the PACU and department(First 24 hours from the surgery)
研究者
Semionov Michael
Primary Investigator
Soroka University Medical Center