Comparison of Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Total morphine consumption
研究概览
简要总结
This study aims to compare the costotransverse foramen block with erector spinae plane block in modified radical mastectomy.
详细描述
Postoperative pain following modified radical mastectomy (MRM) is a considerable consequence, impacting the ipsilateral upper limbs, axillae, and thorax, resulting in diminished functional ability and substantial economic and societal repercussions.
Erector spinae plane block (ESPB), an interfascial block, minimizes nerve and vessel injury by allowing local anesthetics to diffuse across relevant spaces; it is technically simpler and has shown benefits in reducing postoperative analgesic use and pain scores.
A novel technique, the costotransverse foramen block (CTFB), is one type of Inter-transverse process (ITP) blocks. This technique entails the anterior dispersion of the local anesthetic injectate into the paravertebral region, affecting the thoracic nerve at the injection site and neighboring levels, while exhibiting negligible posterior diffusion of dye to the deep back muscles
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult females > 18 years and ≤ 65 years old.
- •American Society of Anesthesiologists (ASA) physical status П-III.
- •Body mass index (BMI) 18-35 kg/m
- •Scheduled for modified radical mastectomy.
排除标准
- •Known allergy or hypersensitivity to local anesthetic agents.
- •Active infection at the injection site (e.g., cellulitis, abscess).
- •Coagulopathy or ongoing anticoagulant/antiplatelet therapy [International Normalized Ratio (INR) > 1.5 or platelet count < 100,000/µL].
- •Severe respiratory, cardiac, hepatic, or renal disease.
- •Morbid obesity.
- •Severe cognitive impairment or uncooperative behavior that could interfere with block placement.
研究组 & 干预措施
CTFB Group
Patients will receive an ipsilateral ultrasound-guided costotransverse foramen block with injection of 20 ml bupivacaine 0.25%.
干预措施: Costotransverse foramen block (Other)
ESPB Group
Patients will receive an ipsilateral ultrasound-guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%.
干预措施: Erector spinae plane block (Other)
结局指标
主要结局
Total morphine consumption
时间窗: 24 hours postoperatively
If the numeric rating scale (NRS) is ≥ 4, an IV morphine dose (3 mg) will be provided Paracetamol 1 gm and ketorolac 30 mg will be administered every 8 hours postoperatively.
次要结局
- Degree of pain(48 hours postoperatively)
- Time to first request of rescue analgesia(24 hours postoperatively)
- Intraoperative fentanyl consumption(Intraoperatively)
- Mean arterial pressure(4 hours postoperatively)
- Heart rate(4 hours postoperatively)
- Incidence of adverse effects(24 hours postoperatively)
研究者
Mai Mohamed El Rawas
Assistant professor of Anaesthesia, Intensive Care and Pain Management, National Cancer Institute, Cairo University Cairo University, Cairo, Egypt.
National Cancer Institute, Egypt