Efficacy of Dexmedetomidine on Postoperative Analgesia After Radical Mastectomy: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Postoperative Pain score
研究概览
简要总结
This prospective, randomized, double-blind study is designed to evaluate the postoperative analgesic efficacy of dexmedetomidine as an adjunct to ropivacaine in erector spinae block in patients undergoing radical mastectomy. The investigators hypothesis is that the administration of ropivacaine 0.5% associated with dexmedetomidine in the blockade via the plane in the erector spinae is less effective in controlling acute postoperative pain in radical mastectomy than the administration of ropivacaine 0.5% without dexmedetomidine.
详细描述
Patients undergoing radical mastectomy are randomly assigned to receive, in addition to standard general anesthesia, a block of the erector spinae plane with ropivacaine at a dose of 0.5% for the control group (n = 13) and ropivacaine at a dose of 0.5% more dexmedetomidine at 0.3 mcg kg (n = 15) for the intervention group. General anesthesia was induced using anxiolysis with midazolam at 30 mcg / kg corrected weight, as induction, propofol at a dose of 1.5 - 2 mg kg, opioid analgesia with fentanyl at a dose of 3 mcg / kg weight corrected with 30% according to ideal weight initial bolus dose, and dose as required, neuromuscular relaxation with cisatracurium at a dose of 0.1 mg / kg.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The outcome assessor did not know the allocation of the participants. The patient is not informed of the medication used in the erector spinae block.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing radical mastectomy for pathology "breast cancer"
- •Patient undergoing anesthetic technique due to erector spinae plane block
- •Informed consent to perform the anesthesia technique.
- •Karnofsky> 80 points
排除标准
- •Emergency surgery
- •Patient with mental pathology that prevents pain assessment.
- •Rejection of anesthetic technique.
- •Patient with allergy to local anesthetics
- •Patient with local infection of the puncture site for application of the erector spinae block
研究组 & 干预措施
Ropivacaine plus Dexmedetomidine
In addition to standard general anesthesia, patients receive erector spinae block with ropivacaine at a dose of 0.5% plus dexmedetomidine at 0.3 mcg / kg corrected in a volume of 20 ml at the level of thoracic vertebra number 4, guided with ultrasound and under sterile technique, the date and time of application are recorded on the data collection sheet.
干预措施: Ropivacaine plus dexmedetomidine (Drug)
Control group
In addition to standard general anesthesia, patients receive erector spinae block with ropivacaine at a dose of 0.5% in a volume of 20 ml at the level of thoracic vertebra number 4, guided with ultrasound and under sterile technique, the date and time of application are recorded on the data collection sheet.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Postoperative Pain score
时间窗: 24 hours
The intensity of pain is evaluated by the visual analog scale (VAS) that measures pain severity expressed on a numerical scale of 0-10: 0, "no pain"; 10, "worst pain imaginable"
次要结局
- Additional opioid-type drugs(24 hours)
- Postoperative nausea and vomiting(24 hours)