The Effect of Rhomboid Intercostal and Subserratus Plane Block on the Postoperative Analgesia of Patients Undergoing Radical Mastectomy: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- The postoperative morphine consumprtion
研究概览
简要总结
This clinical trial will be conducted at Tanta University Hospitals, General Surgery Hospitals on female patients undergoing radical mastectomy
. All the patients will receive general anesthesia.
The patients will be randomly allocated into one of the following two groups;- - Control group (30 patients): The patients in this group will receive sham rhomboid intercostal and subserratus plane.
- Rhomboid intercostal and subserratus plane block group (30 patients): The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.
The primary outcome measure will be the total dose of morphine consumed in the first 24 h after surgery and the secondary outcome will be the postoperative pain score.
详细描述
This prospective randomized controlled study will be carried out on female patients who will be presented for radical mastectomy in the general surgery department in Tanta university hospitals over three month duration and 6 months follow up that starts immediately after obtaining ethical committee approval, an informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.
Any unexpected risks that will appear during the research will be announced to the participants and to the ethical committee at time and adequate measures will be taken to resolve and avoid these risks.
Expected risks to the patients: patients enrolled in this study will minimal risk of local hematoma that which will be managed by adequate compression and minimal risk of infection that will be guarded against by adequate sterilization and prophylactic antibiotic.
There will be adequate supervision to maintain the privacy of patients and confidentiality of data.
There will be no conflict of interest, nor conflict with religion, law, or society standards.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participants will be kept blind through the use of sham block in the control group.
Outcome assessors will be blinded as they will be anesthesia resident and nurse not participating in the study.
The investigators will be blinded
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •Aged 40-75 years
- •ASA class I-II
- •Presented for elective radical mastectomy.
排除标准
- •Patients refused to participate.
- •Patients with known or suspected allergy to the used medication.
- •Patients with preoperative chronic pain
- •Patients received preoperative opioids or gabapentoids.
- •Patients with major cardiac, renal, respiratory, or hepatic disease.
- •Patients with potential risk of coagulopathy
- •Uncooperative patients.
- •Obese patients with BMI >36
结局指标
主要结局
The postoperative morphine consumprtion
时间窗: The first 24 hours postoperatively
3 mg morphine i.v will be given when the postoperative VAS score was 4 or more considering the total dose consumption in the first postoperative day not exceeding 15 mg
次要结局
- The postoperative pain score(The first 24 hours postoperatively)
研究者
Sameh Abdelkhalik Ahmed Ismaiel
Dr
Tanta University