Analgesic Efficacy of the Pectoral Nerve Block Type 1 for Breast Subpectoral Implant Surgery: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Morphine consumption
研究概览
简要总结
Breast augmentation surgery can cause important postoperative pain, especially when bilateral subpectoral implants are used. The investigators hypothesized that a technique of regional analgesia, the pectoral nerve block type I (or "PECS I block") would reduce pain within the first twenty-four hours and, in turn, morphine consumption and associated side effects. This is a randomized, controlled, double-blind study which compares intra and postoperative analgesia with or without PECS I block in breast 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, 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
- •Every female who will benefit of a bilateral subpectoral breast augmentation
- •Age more than 18 years
- •Social insured
排除标准
- •refusal of the patient
- •Age less than 18 years
- •Inability to consent
- •History of thoracic surgery or breast implants
- •Pregnancy
- •Inability to use a patient controlled analgesia
- •Contraindication of the use of opioids or local anesthetics
- •Pathology of hemostasis, infection
- •Can not use a PCA
- •Patients under long-term opioids (WHO pain ladder 2 and 3)
- •Patient presenting neuropathic pain during the preoperative period (score greater than or equal to 4 to the DN4 questionnaire, or taking anti-epileptic or antidepressant treatments for neuropathic pain)
研究组 & 干预措施
Control group
PECS block performed with Saline solution instead of local anesthetic
干预措施: Placebo (Drug)
PECS group
PECS block performed with Ropivacaine 3.75mg/mL
干预措施: Ropivacaine (PECS bloc) (Drug)
结局指标
主要结局
Morphine consumption
时间窗: During the first 24 postoperative hours
Morphine consumption by use of patient control analgesia within the first twenty-four hours after surgery.
次要结局
- Aldrete score(During the first two postoperative hours)
- First administration of morphine(During the first 24 postoperative hours)
- Post-operative nausea and/or vomiting(During the first 24 postoperative hours)
- Post-operative pain(During the first 24 postoperative hours)
- 4-point sedation scale(During the first two postoperative hours)
- Intra-operative opioids consumption(During procedure execution)
- Post-operative anti-emetic consumption(During the first 24 postoperative hours)
- Time physiological function recovery(During the first six postoperative hours after tracheal extubation)