PECTORAL PLANE BLOCK COMPAIRED TO ERECTOR SPINAE PLANE BLOCK IN MULTIMODAL ANALGESIA FOR MASTECTOMY PATIENTS IN SOUTH ASIAN POPULATION -A PROSPECTIVE RANDOMISED CONTROL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Mean Morphine consumption
研究概览
简要总结
This prospective randomized controlled trial was conducted at the Department of Anesthesia, Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH&RC), Lahore. The sample size was calculated based on a previous study by Gad M. (2019) on patients undergoing modified radical mastectomy , where the mean morphine consumption in first 24 hours post operatively was reported as 16.7 ± 7.21 mg in the erector spinae plane (ESP) block group and 10.7 ± 3.12 mg in the pectoral plane block (PECS) group. Using the formula for comparison of two means with unequal standard deviations, and assuming a 90% power, 95% confidence interval, and a 10% dropout rate, the required sample size was determined to be 42 patients, with 21 patients in each group.
详细描述
This prospective randomized controlled trial was conducted at the Department of Anesthesia, Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH&RC), Lahore. The sample size was calculated based on a previous study by Gad M. (2019) on patients undergoing modified radical mastectomy , where the mean morphine consumption in first 24 hours post operatively was reported as 16.7 ± 7.21 mg in the erector spinae plane (ESP) block group and 10.7 ± 3.12 mg in the pectoral plane block (PECS) group. Using the formula for comparison of two means with unequal standard deviations, and assuming a 90% power, 95% confidence interval, and a 10% dropout rate, the required sample size was determined to be 42 patients, with 21 patients in each group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA physical status II or III, biopsy proven breast cancer, and were undergoing unilate l modified radical mastectomy
排除标准
- •. Exclusion criteria included patient refusal to participate, age less than 18 years, diagnosed allergy or contraindication to local anesthetic, chronic pain, obesity (BMI >35), non-cancerous or undiagnosed breast lesions, ASA IV status, and emergency surgery.
研究组 & 干预措施
PECTORAL PLANE BLOCK
We will infiltrate local anesthesia in Pectoral Plane under ultrasound guidance.
干预措施: regional block (Procedure)
ERECTOR SPINAE PLANE BLOCK
We will infiltrate local anesthesia in ERECTOR spine Plane under ultrasound guidance.
干预措施: regional block (Procedure)
结局指标
主要结局
Mean Morphine consumption
时间窗: 12 hours
calculate morphine consumption intraoperatively and post operative at 12 hours
次要结局
未报告次要终点