Comparison of the Postoperative Analgesic Efficacy of Serratus Plane Block With Different Adjuvant Agents in Breast Cancer Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Postoperative analgesic efficacy
研究概览
简要总结
Pain after breast surgery has been described as moderate to severe in intensity and, if inadequately treated, increases postoperative morbidity, hospital cost, and the incidence of persistent postoperative pain. Serratus anterior plane block is an interfascial injection technique for analgesia of the chest wall. The aim of this study was to investigate the effect of magnesium and dexmedetomidine as adjuvant agents on postoperative analgesia in serratus anterior plane block in patients undergoing modified radical mastectomy.
详细描述
In this prospective, double-blind, randomised controlled study, a total of 75 patients aged 30-70 years, who were planned for elective modified radical mastectomy after ethics committee approval, were included. Patients were randomly divided into three groups. After induction of general anaesthesia, serratus anterior plane block was applied to all patients. Group B received bupivacaine 30 ml (0.25%), Group D received bupivacaine 30 ml (0.25%) + dexmedetomidine 1μg/kg, Group M received bupivacaine 30 ml (0.25%) + 500 mg magnesium sulphate. Haemodynamic parameters, numerical rating scale (NRS) scores, number of tramadol use with patient-controlled analgesia device, additional analgesic drug consumption and side effects were recorded at 2, 6, 12 and 24 hours postoperatively.
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, Care Provider)
盲法说明
Drugs administered in regional blocks were prepared according to group randomisation by an anaesthetist not involved in patient management or data collection. Patients were divided into three groups using a sealed envelope
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30-70 years old, ASA I-II-III patient group,
- •Not hypersensitive to the drugs to be used in the study or to the substances contained in them,
- •No infection or anatomical deformation at the site of intervention,
- •No antithrombotic treatment and normal coagulation parameters,
- •Patients who have the consent of themselves or one of their legal guardians.
排除标准
- •Less than 30 years of age, older than 70 years of age or ASA (American Society of Anaesthesiologists) Classification IV,
- •Receiving antithrombotic therapy with abnormal coagulation parameters,
- •Infection or anatomical abnormality at the blockage site,
研究组 & 干预措施
Group B
Group B (Blockade with Bupivacaine): 30 mL bupivacaine (0.25%)
干预措施: Bupivacain (Drug)
Group M
Group M (Bupivacaine+Magnesium Blockade): 30 mL bupivacaine (0.25%) + 500 mg magnesium sulphate
干预措施: Bupivacaine and Magnesium sulfate (Drug)
Group D
Group D (bupivacaine + dexmedetomidine ile Blokaj): 30 mL bupivacaine (% 0.25) + 1 μg/kg dexmedetomidine.
干预措施: Bupivacaine and Dexmedetomidine ile Blokaj (Drug)
结局指标
主要结局
Postoperative analgesic efficacy
时间窗: until the 24th hour postoperatively
Hemodynamic parameters (heart rate, noninvasive mean arterial blood pressure, peripheral oxygen saturation), numerical rating scale (NRS) scores, number of tramadol uses with patient-controlled analgesia device, and additional analgesic drug consumption were recorded at 2, 6, 12, and 24 hours after surgery. The Numerical Rating Scale (NRS) is a subjective scale in which patients rate their pain intensity by selecting a number between 0 and 10. 0 means "no pain," while 10 means "worst pain imaginable." Patients typically rate their pain over the past 24 hours. It can be used in both verbal and written formats.
次要结局
- Complications due to adjuvant agents(until the 24th hour postoperatively)
研究者
Dilek Yamac
specialist doctor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey