Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia in Modified Radical Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Total fentanyl dose.
研究概览
简要总结
Thoracic epidural anesthesia (TEA) and paravertebral block (PVB) have been utilized to give perioperative regional anesthesia in the trunk. TEA is technically troublesome in some cases, and is associated with a danger of serious complications, such as epidural hematoma, nerve injury, and hypotension. PVB has the benefit of perception of the needle position using ultrasonography. However, PVB is also additionally connected with a danger of serious complications, such as pneumothorax, hypotension, or nerve injury. Newer approaches to deal with PVB have been the focal point of numerous techniques lately; these methodologies incorporate retrolaminar block (RLB) and erector spinae plane block (ESPB)
详细描述
Modified radical mastectomy is one of the commonly performed breast surgery. Postoperative pain following mastectomy should be minimized, as in a number of women it may chronically persist for months in the form of post-mastectomy pain syndrome.
Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques as para-vertebral block and thoracic epidural anesthesia have possible complications and technical difficulties.
The new alternative regional techniques such as erector spinae plane block and retrolaminar block are clinical trials for providing a safe and easy with good hemodynamic and recovery profile with adequate perioperative analgesia for a large section of patients undergoing mastectomy operation in order to reduce opioids consumption and subsequently avoid opioid-related adverse effects.
As percent of post-operative rescue analgesia is 16.7% and 60% for RLB group and ESPB group respectively. So, sample size is 46 patients (23 patients in each group). Sample was calculated using OPEN EPI program with confidence level 95% and power 80%.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient acceptance.
- •21 - 64 years of age.
- •American Society of Anesthesiologist physical status class I,II.
- •Body Mass Index 25-35 kg/m
- •Female patient undergoing elective unilateral modified radical mastectomy under general anesthesia.
排除标准
- •Coagulation disorders or anticoagulant therapy.
- •Known allergy to study drugs (Bupivacaine, Fentanyl)
- •Infection at the injection site.
- •Patients having chronic pain or on pain treatment.
- •Advanced renal, respiratory, hepatic or cardiovascular disorders.
- •Uncooperative patients.
- •Duration of surgery > 3hours.
- •Pregnant or lactating females.
- •Metastasis.
研究组 & 干预措施
ultrasound guided Retrolaminar Block
ultrasound guided Retrolaminar Block (RLB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.
干预措施: ultrasound guided Retrolaminar Block (Drug)
ultrasound guided erector spinae
ultrasound guided Erector Spinae Plane Block (ESPB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.
干预措施: ultrasound guided Erector Spinae Plane (Drug)
结局指标
主要结局
Total fentanyl dose.
时间窗: from induction to end of surgery
The anesthesiologist will administer intravenous fentanyl 0.5 μg/kg when the heart rate or blood pressure of the patients increased \>20% from basal measurements after exclusion of other causes.
次要结局
- Time of requirement of rescue dose of Fentanyl.(up to 24hour postoperative)
- pain intensity by Visual Analogue Scale(at 30 minutes then at 2, 4, 8, 12, 18 and 24 hours post-operatively.)
- Total amount of postoperative Fentanyl(up to 24hour postoperative)
- Post-operative nausea and vomiting(up to 24hour postoperative)
- Complications including hypotension MAP < 60, bradycardia HR < 60b/m, nausea, vomiting and allergic reactions.(up to 24hour postoperative)
- Overall patient satisfaction(up to 24hour postoperative)
研究者
Alshaimaa Abdel Fattah Kamel
clinical professor
Zagazig University