A Comparative Study for Evaluation of the Analgesic Profile of Ultrasound-Guided Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Fentanyl consumption
研究概览
简要总结
The purpose of this study is to compare the analgesic profile of modified pectoral nerves block and serratus plane block in patients undergoing mastectomy.
详细描述
This study includes three groups. The first group will receive ultrasound-guided modified pectoral nerves block prior to induction of general anesthesia. The second one will receive ultrasound-guided serratus plane block prior to induction of general anesthesia. The third one will not receive any block preoperatively.
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
- Single (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
- •American Society of Anesthesiologists( ASA) I or II and scheduled for major breast cancer surgery( modified radical mastectomy or conservative mastectomy with axillary evacuation).
排除标准
- •Local infection at the site of the block, coagulations abnormalities, allergy to local anesthetics or morphine, body mass index> 35, patient refusal, severe respiratory or cardiac disorders, pre-existing neurological deficits, hepatic or renal insufficiency, chronic pain syndrome, chronic analgesic use and psychiatric disorders.
研究组 & 干预措施
modified pectoral nerves block
Modified pectoral nerves block with general anesthesia. Using the ultrasound, 10 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the pectoralis major and minor muscles. And another 20 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the pectoralis minor and the serratus anterior muscles.
干预措施: Bupivacaine 0.25% with epinephrine (Drug)
serratus plane block
Serratus plane block with general anesthesia. Using the ultrasound, 0.4 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the serratus anterior muscle and the underlying ribs.
干预措施: Bupivacaine 0.25% with epinephrine (Drug)
结局指标
主要结局
Fentanyl consumption
时间窗: Intraoperative
Total morphine consumption
时间窗: The first 24 hours postoperative
Visual analogue scale score at rest and during shoulder movement
时间窗: The first 24 hours postoperative
次要结局
- Nausea and vomiting(The first 24 hours postoperative)
- Mean arterial blood pressure(Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative)
- Heart rate(Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative)
- Time to first requirement of rescue analgesia(The first 24 hours postoperative)
- Sedation score(Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative)
- Respiratory rate(Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative)
- Patient satisfaction with postoperative analgesia(One week after surgery)
研究者
Khaled Mostafa Kamel
Assistant Lecturer of Anesthesia and Pain Relief
Cairo University