Comparison of Effectiveness of Adding Ketamine or Neostigmine to Bupivacaine for Ultrasound Guided Serratus Anterior Plane Block in Modified Radical Mastectomy , Randomized Double Blinded Comparative Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Time of first request of analgesia
研究概览
简要总结
The aim of this study is to Investigate the analgesic efficacy of adding ketamine compared to neostigmine to local anesthetic in Ultrasound guided Serratus anterior plane block for patients undergoing Modified Radical Mastectomy.
详细描述
Breast cancer is the most common malignancy among females with incidence of 18,660 patients each year in Egypt. Modified Radical Mastectomy is considered the main surgical management for breast cancer accounting for 31% of all breast surgery cases.
Ultrasound guided Serratus anterior plane block provides analgesia for breast and lateral thoracic wall surgeries by blocking nerves that are located in a compartment between the serratus anterior and the latissimus dorsi muscles ( the intercostobrachial nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve and thoracodorsal nerve).
A previous study demonstrated the analgesic efficacy of ketamine in patients undergoing modified pectoral nerve block in breast cancer surgery as evidenced by prolonged time to first rescue analgesia and reduced total opioid consumption.
Neostigmine has been used as an additive to local anesthetics to prolong the analgesic effect. Although there is good evidence for a spinal action of neostigmine, its analgesic efficacy as an adjuvant to local anesthetic is still unclear.
The aim of this study is to Investigate the analgesic efficacy of adding ketamine compared to neostigmine to local anesthetic in Ultrasound guided Serratus anterior plane block for patients undergoing Modified Radical Mastectomy.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •● Female patients
- •Type of surgery; Modified Radical Mastectomy (MRM).
- •Physical status ASA II, III.
- •Age ≥ 21 and ≤ 65 Years.
- •Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
排除标准
- •● Patients with Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
- •History of psychological disorders and/or chronic pain.
- •Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
- •Infection of the skin at the site of needle puncture area
- •Patient refusal.
- •Severe respiratory or cardiac disorders.
- •Advanced liver or kidney disease.
- •Pregnancy.
- •Patient with surgery duration more than two hours
研究组 & 干预措施
ketamine
Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml ketamine
干预措施: Serratus Anterior Plane Block Technique (Procedure)
ketamine
Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml ketamine
干预措施: General anesthesia (Procedure)
ketamine
Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml ketamine
干预措施: bupivacaine +ketamine (Drug)
Neostigmine
Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml neostigmine
干预措施: Serratus Anterior Plane Block Technique (Procedure)
Neostigmine
Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml neostigmine
干预措施: General anesthesia (Procedure)
Neostigmine
Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml neostigmine
干预措施: bupivacaine + neostigmine (Drug)
Control
Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml normal saline.
干预措施: Serratus Anterior Plane Block Technique (Procedure)
Control
Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml normal saline.
干预措施: General anesthesia (Procedure)
Control
Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml normal saline.
干预措施: bupivacaine +saline (Drug)
结局指标
主要结局
Time of first request of analgesia
时间窗: 24 hours postoperative
it will be calculated from the time of complete injection of local anesthetics till the numerical rating scale (NRS) is ≥3.
次要结局
- Numeric Pain Rating Scale(24 hours)
- The total amount of morphine consumption(24 hours postoperative)
- Total amount of intraoperative fentanyl.(2 hours)
研究者
Bassant M. Abdelhamid
associate professor
Cairo University