Ultrasound Guided Serratus Anterior Plane Block Versus Costotransverse Block on Postoperative Analgesia and Safety Following Modified Radical Mastectomy Surgeries
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale score at 0,6,12 and 24 hour post-operatively. visual analogue scale is a scale from 0 to 10, 0 represent no pain at all and 10 represent the worst pain
研究概览
简要总结
Adequate pain management following modified radical mastectomy (MRM) is crucial for early ambulation and patient satisfaction. Breast cancer is the most common malignancy in females, with an increasing incidence in recent years. Surgery is one of the mainstays of therapy for breast cancer, and modified radical mastectomy (MRM) is the most effective and common type of invasive surgical treatment. Post-mastectomy pain syndrome (PMPS) is a surgical complication of breast surgery characterized by chronic neuropathic pain. The aim of this study is to investigate the efficacy and safety of single injection CTB versus SAPB on post-operative acute pain as a part of a multimodal analgesia plan in patients undergoing MRM.
详细描述
Patients will be divided randomly by the computer into three groups, group (A): will receive serratus anterior plane block, group (B): will receive costotransverse block and group(C): patient controlled analgesia group (PCA).
Group (A) (SAPB):
SAPB will be performed using an ultrasound machine with a high-frequency linear probe . All patients will be in lateral position to perform the block. At the level of the fourth rib with 45-degree angle, targeting the plane between the latissimus dorsi and serratus muscles, SAPB block will be performed unilaterally on the ipsilateral side of surgery.
Group (B) (CTB):
CTB will be performed using an ultrasound machine with a high-frequency linear probe. All patients will be in lateral position to perform the block. CTB block will be performed unilaterally on the ipsilateral side of surgery at the level of fourth rib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •American Society of Anaesthesiologists (ASA) Physical Status Class I, II.
- •Scheduled for modified radical mastectomy (MRM).
- •Body weight ranging from 60 to 100 kilograms.
排除标准
- •Declining to give a written informed consent.
- •History of allergy to the medications used in the study.
- •Contraindications to regional anesthesia (including patient: refusal, coagulopathy, and local infection).
- •Psychiatric disorders.
- •Significant cognitive dysfunction.
- •American Society of Anesthesiologists (ASA) Physical Status Class III and IV.
- •Daily use of opioids.
- •Obesity (BMI > 35 kg/m2).
研究组 & 干预措施
serratus anterior plane block
while the patients in lateral position, serratus anterior plane block will be done using high frequency linear ultrasound probe at the level of fourth rib.30 ml of 0.25% bupivacaine will be injected.
干预措施: serratus anterior plane block (Procedure)
costotransverse plane block
while the patients in lateral position, costotransverse block will be done using 22-gauge echogenic needle. the needle is advanced in-plane lateral to the spinous process of the 4th thoracic vertebra from caudally cephalad.30 ml of 0.25% bupivacaine will be injected
干预措施: costotransverse block (Procedure)
patient controlled analgesia
After successful extubation, patients will be transferred to PACU. Patients will receive a bolus dose of 5 mg nalbuphine then PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr with self-administration bolus of 0.5ml with 15 min lock-out time.
干预措施: patient controlled analgesia (Procedure)
结局指标
主要结局
Visual Analogue Scale score at 0,6,12 and 24 hour post-operatively. visual analogue scale is a scale from 0 to 10, 0 represent no pain at all and 10 represent the worst pain
时间窗: 24 hour post-operative
Visual Analogue Scale score will be assessed at both rest and arm elevation
次要结局
- The total dose of nalbuphine consumption is used postoperatively per patient rescue analgesia for 24.(24 hour post-operative)
- Incidence of chronic pain after 6 months of surgery(6 months after surgery)