Analgesic Efficacy of Ketamine Versus Neostigmine as Adjuvants to Bupivacaine During Ultrasound-guided Serratus Anterior Plane Block in Modified Radical Mastectomy
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- analgsic consumption
研究概览
简要总结
This study is designed to investigate the analgesic efficacy of ketamine compared to neostigmine as adjuvants to LA in ultrasound guided Serratus Anterior Plane Block (SAPB) in patients undergoing Modified Radical Mastectomy. We hypothesize that adding either neostigmine or ketamine to bupivacaine in ultrasound guided SAPB would increase the total analgesic duration and decrease the total 24 hr postoperative Nalbuphine consumption compared to SAPB with bupivacaine only. The first 24 hr of postoperative Nalbuphine consumption is set as the primary outcome. The time of the first request of analgesia, pain score, side effects of drugs and patient hemodynamics are set as the secondary outcomes.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA II patients, BMI< 35Kg/m2
排除标准
- •refusal of participation, ASA III or above, history of allergy to the study drugs, BMI> 35kg/m2, coagulation disorders, psychiatric illnesses that may interfere with pain evaluation, epileptic patients, patients with tachy or brady arrthymias, patients with increased intracranial tension
研究组 & 干预措施
group 1
consists of patients receiving Serratus anterior plane block using Bupivacaine + Ketamine.
干预措施: Adjuvants, Anesthesia (Drug)
group 2
consists of patients receiving Serratus anterior plane block using Bupivacaine + neostigmine.
干预措施: Adjuvants, Anesthesia (Drug)
group 3
consists of patients receiving Serratus anterior plane block using Bupivacaine + normal saline.
干预措施: Adjuvants, Anesthesia (Drug)
结局指标
主要结局
analgsic consumption
时间窗: first 24 hours postoperative
total amount of consumed nalbuphine
次要结局
- time to rescue analgesia(first 24 hours postoperative)
- pain scores(first 24 hours postoperative)
研究者
Aya Hisham
Lecturer of Anesthesia
Ain Shams University