The Effect of Retrolaminar Thoracic Paravertebral Block on the Postoperative Analgesia of Patients Undergoing Breast Surgeries: Prospective Randomized Double Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- The postoperative rescue analgesia consumption
研究概览
简要总结
This clinical study will be conducted on female patients admitted to The General Surgery Department of Tanta Faculty of Medicine for a period of 9 months.
Patients will be randomly allocated into one of the following two groups;- • Ordinary approach group (30 patients): The patients in this group will receive ordinary ultrasound-guided thoracic paravertebral block.
• Retro-laminar approach group (30 patients): The patients in this group will be receive real ultrasound-guided Retrolaminar thoracic paravertebral block.
All the patients will receive general anesthesia with attachment to a monitor (5 ASA Monitoring) In addition to bispectral index.
详细描述
This prospective randomized controlled study will be carried out on female patients who will be presented for breast surgery in the General Surgery Department in Tanta university hospitals over 3 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 have a very minimal risk of pleural puncture that will be managed by adequate observation and chest tube insertion whenever indicated. They may have a minimal risk of hypotension that will be managed by intravenous fluids and intravenous ephedrine 10 mg.
There will be adequate supervision to maintain the privacy of patients and confidentiality of data that will be used in the current study only.
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 and the investigator will be kept blinded by the aid of closed sealed envelops.
The measurements will be collected by the aid of assistant resident who will not participating into the study and blinded to it.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •Aged 40-60 years
- •ASA class I-II.
- •Presented for elective breast surgery.
排除标准
- •Patients refused to participate
- •Patients with known or suspected or known allergy to the used medication.
- •Patients with spinal deformities.
- •Patients with preoperative chronic pain,
- •Patients received preoperative opioids or gabapentoids.
- •Patients with major cardiac, renal, respiratory, or hepatic disease.
- •Patients with suspected or diagnosed coagulopathy
- •Uncooperative patients.
- •Obese patients with BMI >36
结局指标
主要结局
The postoperative rescue analgesia consumption
时间窗: The first 24 hours postoperatively
Morphine consumption in the first 24 h 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 incidence of complications(up 24 hours from performing the technique)
研究者
Sameh Abdelkhalik Ahmed Ismaiel
Dr
Tanta University