Thoracic Paravertebral Block Versus Pectoral Nerves Block (Modified PECS) Block in Breast Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- PCA morphine consumption in the two groups within the first 24 postoperative hours
研究概览
简要总结
Purpose to compare paravertebral thoracic block (PVB) and pectorals nerves block as analgesic option for major breast surgery.
102 patients undergoing reconstruction breast surgery will be randomized into two groups: Group PVB (n=51) will receive US guided paravertebral thoracic block (between T2-T6) performed with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction.
Morphine patient control analgesia (PCA) with loading dose i.v. titrated by the PACU nurse if pain > 5/10 at rest Group PECS (n=51) will receive US guided pectorals nerves block performed with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction.
Morphine PCA with loading dose i.v. titrated by the post-anesthesia care unit (PACU) nurse if pain > 5/10 at rest
Primary Outcome Measures:
Morphine consumption (mg) (Time Frame: 24 hours) in two Groups
Secondary Outcome Measures:
Pain at rest and during movement quantified as Numerical Rating Scores (0-10) during the first 24 hours postoperatively.
Eventual side effects such as nausea/vomiting. Time necessary to perform the procedure. Pain during procedure execution quantified as Numerical Rating Scores (0-10) Hypnotic and opioids intraoperative consumption to ensure general anesthesia with Bispectral Index between 40 and 60.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age> 18 years
- •ASA score I - II - III
- •undergoing elective reconstruction breast surgery
- •signed informed consent
排除标准
- •chronic therapy with opioids/ antidepressants
- •urgent/emergent surgery
- •postoperative transfer to the intensive care unit
- •known allergy to any drug medication
- •local skin infection
- •alcohol or drug abuse
研究组 & 干预措施
PVB
51 patients receiving US guided homolateral paravertebral thoracic block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).
干预措施: Paravertebral Thoracic block (Procedure)
PVB
51 patients receiving US guided homolateral paravertebral thoracic block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).
干预措施: Levobupivacaine 0.25% (Drug)
PVB
51 patients receiving US guided homolateral paravertebral thoracic block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).
干预措施: Morphine (Drug)
PECS
51 patients receiving US guided pectorals nerve block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).
干预措施: Pectorals nerve block (Procedure)
PECS
51 patients receiving US guided pectorals nerve block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).
干预措施: Levobupivacaine 0.25% (Drug)
PECS
51 patients receiving US guided pectorals nerve block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).
干预措施: Morphine (Drug)
结局指标
主要结局
PCA morphine consumption in the two groups within the first 24 postoperative hours
时间窗: 24 hours postoperatively
次要结局
- Numerical Rating Scores for pain at rest and during movement(24 hours postoperatively)
- Postoperative nausea/vomiting incidence(24 hours postoperatively)
- Time of performance(During procedure execution)
- Propofol consumption in intraoperative period(Intraoperative period)
- Opioids (remifentanyl) consumption in intraoperative period(Intraoperative period)
- Numerical Rating Scores during procedure execution(During procedure execution)
研究者
Giorgio Danelli
Chief of the Anaesthesia Department, Istituti Ospitalieri, Cremon
Istituti Ospitalieri di Cremona