Evaluation of Analgesic Efficacy of Cervical Erector Spinae Plane Block in Proximal Humeral Fracture Surgery, A Motor-Sparing Block
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Degree of pain
研究概览
简要总结
This study aims to evaluate the efficacy of cervical erector spinae plane block (ESPB) in managing postoperative pain following proximal humerus fracture repair in patients receiving general anesthesia.
详细描述
Proximal humeral fracture (PHF) is among the most common fractures in the elderly, particularly in women. Postoperative pain following surgical repair of PHF represents a significant clinical challenge. It directly impacts the patient's recovery, adherence to rehabilitation, and long-term functional outcomes.
The erector spinae plane block (ESPB) is a relatively novel regional anesthesia technique that has gained popularity due to its simplicity, safety profile, and broad applicability.
The resulting multi-dermatomal sensory block covers the anterior, lateral, and posterior thoracic and abdominal walls. This widespread effect is attributed to cranial and caudal spread of the anesthetic, facilitated by the thoracolumbar fascia. Radiologic studies have demonstrated anesthetic spread extending across three to four vertebral levels from the injection site.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-70 years old.
- •Adults scheduled for unilateral proximal humerus open reduction and internal fixation (ORIF).
- •American Society of Anesthesiologists (ASA) physical status I-II patients.
排除标准
- •Patient refusal.
- •Coagulopathy [International Normalized Ratio (INR) >1.4, platelets <100,000/mm³].
- •Local infection at the block site.
- •Allergy to local anesthetics or opioids.
- •History of drug addiction or chronic opioid use.
- •Significant neurological or psychiatric disorders.
- •Hemodynamically unstable patients.
研究组 & 干预措施
Group ESPB (study group)
Patients will receive cervical erector spinae plane block (ESPB) after the induction of general anesthesia.
干预措施: Cervical erector spinae plane block (Drug)
Group C (Control group):
Patients will receive general anesthesia alone with no block.
干预措施: General anesthesia (Drug)
结局指标
主要结局
Degree of pain
时间窗: 24 hours postoperatively
Each patient will be instructed about postoperative pain assessment with the visual analog scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at 4, 8, 12, 18, and 24 h after surgery.
次要结局
- Intraoperative fentanyl consumption(Intraoperatively)
- Total amount of nalbuphine consumption(24 hours postoperatively)
- Time to the 1st rescue analgesia(24 hours postoperatively)
- Diaphragmatic excursion(Intraoperatively)
- Mean arterial pressure(12 hours postoperatively)
- Heart rate(12 hours postoperatively)
- Incidence of complications(24 hours postoperatively)
研究者
Ahmed Alsyed
Resident of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Menoufia University, Egypt
Menoufia University