Erector Spinae Catheter Versus Paravertebral Catheter for Pain Management in Modified Radical Mastectomy for Cancer Patients: A Randomized Double-Blind Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Total 48 hours Post-operative opioid consumption to keep VAS score ≤4.
研究概览
简要总结
All patients admitted in National Cancer institute, Cairo University for breast surgeries will be investigated for inclusion criteria in the current study. And will be enrolled if fulfilled the criteria into 2 groups
.70 patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35)
- All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving general anesthesia
- Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic
详细描述
- 70patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35)
- All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving GA
- Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic.
- Random numbers were generated using a computer-generated randomization code and were sealed in an opaque envelope. Randomization was conducted by a person who was not involved in the study.
- An independent observer who was blind to the group assignment checked the intraoperative and postoperative data.
- VAS pain score immediately postoperative and at 2,4,6, 8,12,18,24,36 ,48hrs.postoperative.
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, Investigator)
盲法说明
An independent observer who will be blind to the group assignment checked the intraoperative and postoperative data also patient will be be blinded also
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •.Physical status ASA II.
- •. Patients (age 20-70yrs) scheduled for breast surgeries for breast cancer under general anesthesia
排除标准
- •.History of psychological disorders.
- •Known sensitivity or contraindication to local anesthetics.
- •Localized infection at the site of block.
- •patients with coagulopathy or an (INR ≥ 2)
结局指标
主要结局
Total 48 hours Post-operative opioid consumption to keep VAS score ≤4.
时间窗: 48 hours postoperative
the VAS score rating, in which 0 = "no pain" and 10 = "worst possible pain". both during rest and movement
次要结局
- 1st request of analgesia(48 hours postoperative)