Pectoral Nerve (PECS) Block for Cardiac Implantable Electronic Devices (CIED) Implantation Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Postoperative morphine consumption
研究概览
简要总结
We aim to determine whether pectoral nerve block (PECS) performed after induction of anesthesia but before surgical incision results less opioid use in the post operative period compared with local infiltration alone in children undergoing Cardiac Implantable Electronic Device (CIED) surgery.
详细描述
The current anaesthetic management of CIED surgery at Sickkids is local anaesthetic infiltration by the EP cardiologist or a Pectoral nerve block (PECS) on an ad-hoc basis depending on the anaesthesiologist on a case by case basis. It is not known whether one technique provides better post- operative pain control and fewer adverse events than the other. In either case, the patient receives opioids as required during and after the procedure. Patients typically go home with a prescription for opioids to be taken for the first few days after surgery.
The PECS block is a recognized effective anaesthetic technique used for both intraoperative and postoperative pain control in adult breast surgery, chest wall procedures as well as one case report for CIED implantation and a small series in paediatric cardiac surgery. The advantages of the PECS block in these surgical procedures includes improved analgesia and reduced opioid use.
The investigators plan to conduct an RCT with two groups.
Group 1 will receive a PECS block (using 0.8 ml/kg of 0.25% bupivacaine with epinephrine 1: 200000 divided in two equal volumes between the two planes) by the anaesthesiologist and local infiltration (up to 0.2 ml/kg of 0.25% bupivacaine with epinephrine 1:200000) by the surgeon.
Group 2 will receive local infiltration (up to 0.8 ml/kg 0.25 % bupivacaine with epinephrine 1:200000) by the surgeon alone.
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, Outcomes Assessor)
盲法说明
The nursing staff in the post anesthesia care unit, patient and outcome assessors will be blinded to the patient allocation.
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients 3-18 years undergoing CIED surgery in the chest
排除标准
- •Children < 3 years of age at time of procedure as bupivacaine is not licensed for this age group.
- •No parental or patient consent
- •Allergy to bupivacaine
- •Pregnancy or lactation
- •Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk.
研究组 & 干预措施
PECS block
A PECS block of 0.25 % bupivacaine with epinephrine 1:200000 (below the toxic dose limit of 3 mg/kg) in divided doses to cover the fascial planes identified in PECS I and PECS II. At the completion of surgery, the wound will be infiltrated with up to 0.2 ml/kg of 0.25 % bupivacaine into the wound.
干预措施: Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration (Drug)
Infiltration
At the completion of surgery, the EP cardiologist will infiltrate the wound with up to 0.8 ml/kg of 0.25 % bupivacaine with epinephrine 1:200000.
干预措施: Bupivacaine 0.25% with epinephrine 1:200000 by wound infiltration only (Drug)
结局指标
主要结局
Postoperative morphine consumption
时间窗: 0 hours
Amount of morphine or morphine equivalents used after surgery
次要结局
- Severity of pain(0 hours, 6 hours, 12 hours and at discharge from hospital)
- Time to discharge from recovery room(Until discharge from recovery room, assessed up to 2 days)
- Incidence of nausea/emesis postoperatively(Until discharge from recovery room, assessed up to 2 days)
- Incidence of pruritus(Until discharge from recovery room, assessed up to 2 days)
- Adverse events(Until discharge from recovery room, assessed up to 2 days)
研究者
Katherine Taylor
Associate Professor
The Hospital for Sick Children