Ultrasound Guided Quadratus Lumborum Block Versus Thoracic Paravertebral Block in Gynacological Cancer Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Visual analogue scale
研究概览
简要总结
This study is to assess and compare the analgesic efficacy and safety of quadratus lumbotum block and paravertebral block in gynacological cancer patients.
详细描述
All patients will be medically checked in the preoperative assessment clinic {history, physical examination, investigations (e.g. complete blood picture, coagulation profile , liver & kidney functions , ECG for patient above 40 years, chest x-ray for patients above 60 years and any other necessary investigations required for risky patients. ) }.
The patients will be randomly allocated into two equal groups(25 patients for each group) with a computer-generated list (www.Random.org).
QLB group: will receive 0.3ml/Kg bupivacaine 0.25% ( keeping in mind not to exceed the maximum recommended toxic dose of plain bupivacaine which is 2.5 mg/Kg & 3mg/Kg with epinephrine).
PVB group: will receive 0.25ml/Kg/side of 0.375% bupivacaine with epinephrine 5ug/ml, yielding the same dose of bupivacaine of 1.875mg/ml at the level of T10.
- In the recovery room, the patients will be continuous monitored for pulse, blood pressure, oxygen saturation.
- Humidified oxygen 3L/min. by nasal prong will be delivered to all patients.
- Portable ultrasound machine , nerve stimulator, pressure injector monitor ,resuscitation equipment &drugs (e.g. epinephrine, lipid emulsion ), sterile gloves and surgical towels should be available.
- Intravenous(IV) 18 gauge cannula will be inserted. Midazolam 0.02 mg/Kg will be administered.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
After approval of The InstitutionalEthics Committee of The National Cancer Institute ,Cairo University, 50 patients scheduled for gynacological cancer surgery will be enrolled in this study
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
- •Inclusion criteria
- •Age ≥ 20 & ≤ 70
- •Body mass index (BMI): Less than forty and more than twenty.
- •Patients undergoing major gynacological cancer surgeries.
排除标准
- •Patient refusal.
- •History of sensitivity to local anesthetic (amide group).
- •History of psychological disorders.
- •Coagulopathies: hereditary (e.g. hemophilia, fibrinogen abnormalities& deficiency of factor II) - acquired (e.g. liver disease, vitamin K deficiency & therapeutic anticoagulants drugs).
- •Localized infection.
- •Morbid obese BMI>
- •Incooperative patients.
- •Patients on chronic pain therapy.
结局指标
主要结局
Visual analogue scale
时间窗: Baseline pain till first 24 hours postoperative
Pain score will be measured according to severity
次要结局
- Patient satisfaction(First 24 hours postoperative)
- Morphine demands postoperative(First 24 hours postoperative)
研究者
Fatma Gomaa Hussein
Principal investigator
National Cancer Institute, Egypt