Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Patient Undergoing Breast Cancer Surgery :A Comparative Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS), scored from 0-10
研究概览
简要总结
To Evaluate the effect of addition of Dexmedetomedine to ultrasound guided modified Pecs block on post operative analgesia & stress response in patient undergoing modified radical mastectomy.
详细描述
60 patients (age ≥29 years) who scheduled for modified radical mastectomy surgery under general anesthesia. Group I (Bupivacaine group): patients underwent modified radical mastectomy were given preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles on the interfasial plane, and 20 ml injected between the Pectoralis minor muscle and the serratus muscle.Group II (Bupivacaine + Dexmedetomidine group) : preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg) divided into 20 ml injected between the pectoralis muscles on the interfasial plane , and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA I - II patients
- •weight 50- 100 kg)
排除标准
- •a history of bleeding diathesis,
- •relevant drug allergy
- •opioid dependence,
- •those with psychiatric illnesses
研究组 & 干预措施
dexmetedomedine
preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg)
干预措施: Dexmedetomidine (Drug)
control
preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine
干预措施: placebo (Drug)
结局指标
主要结局
Visual Analog Scale (VAS), scored from 0-10
时间窗: 48 hours
pain measurement
morphine consumption mg/day
时间窗: 48 HOURS
by Patient-controlled analgesia (PCA) device
次要结局
- first request of analgesia(48 hours)
- level of stress hormones(48 hours)
- Adverse Events(48 hours)
研究者
Dr.mohamad farouk mohamad
lecturer of anesthesia,ICU and pain relief
South Egypt Cancer Institute