The Analgesic Efficacy of the Pectoral Block After Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Intravenous morphine consumption during the first 24 postoperative hours (mg)
研究概览
简要总结
Unilateral mastectomy is associated with moderate to severe postoperative pain. A new regional anaesthetic technique has been recently described, call the PEC block. This technique consists of injecting local anaesthetic between different muscles of the chest in order to relieve postoperative pain. The investigators aim to verify that this technique has a clinical relevant postoperative analgesic effect. For that purpose, the investigators will randomise 50 patients scheduled to undergo unilateral mastectomy into two groups: one group will receive a PEC block after the induction of the general anaesthesia under ultrasound guidance, while the other group will not have this regional procedure.
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, Investigator, 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
- •ASA physical status I-III
- •Patients undergoing unilateral mastectomy
排除标准
- •Contraindications to regional block
- •Pregnancy
- •Inability to give informed consent
- •History of alcohol or drug dependence/abuse
- •History of long term opioid intake or chronic pain disorder
研究组 & 干预措施
PEC block
Ultrasound-guided PEC block after induction of general anaesthesia.
干预措施: PEC block + General anaesthesia (Procedure)
Control
No ultrasound-guided PEC block; only general anaesthesia will be provided.
干预措施: General anaesthesia (Procedure)
结局指标
主要结局
Intravenous morphine consumption during the first 24 postoperative hours (mg)
时间窗: Postoperative day 1
次要结局
- Intravenous morphine consumption on postoperative day 2 (mg)(Postoperative day 2)
- Intravenous morphine consumption in phase 1 recovery (mg)(2 postoperative hours)
- Pain scores at rest on postoperative day 1 (visual analogue scale, 0 - 10)(Postoperative day 1)
- Pain scores at rest on postoperative day 2 (visual analogue scale, 0 - 10)(Postoperative day 2)
- Postoperative nausea and vomiting (yes/no)(Postoperative day 2)
- Pruritus (yes/no)(Postoperative day 2)
- Pain scores at rest in phase 1 recovery (visual analogue scale, 0 - 10)(2 postoperative hours)
研究者
Eric Albrecht
PD Dr
Centre Hospitalier Universitaire Vaudois