Comparative Study of Preoperative Ultrasound-Guided Pericapsular Nerve Group Block and Femoral Nerve Block for Analgesia Before Spinal Anesthesia in Proximal Femur Fracture Fixation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Pain Score During Positioning for Spinal Anesthesia Using Visual Analog Scale (VAS)
研究概览
简要总结
This study will compare two types of ultrasound-guided nerve blocks-Pericapsular Nerve Group (PENG) block and Femoral Nerve Block (FNB)-to evaluate their effectiveness in reducing pain before spinal anesthesia in patients who will undergo surgery for proximal femur fractures. Proximal femur fractures will continue to be common, especially in older adults, and often will cause severe pain that will make it difficult to position patients for spinal anesthesia. Both nerve blocks will aim to reduce pain, improve comfort during spinal anesthesia, and decrease the need for postoperative pain medication.
A total of 60 adult patients who will undergo proximal femur fracture fixation under spinal anesthesia will be enrolled and randomly assigned to receive either a Pericapsular Nerve Group (PENG) block or a femoral nerve block before the procedure. The study will monitor patients' pain scores using the Visual Analog Scale (VAS) at multiple time points, including during positioning and throughout the first 24 hours after surgery. It also will evaluate how long it will take before the patients require rescue pain medication, and how much total pain medication will be needed.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Scheduled for proximal femur fracture fixation under spinal anesthesia
- •Classified as American Society of Anesthesiologists (ASA) physical status I, II, or III
- •Ability to understand and use the Visual Analog Scale (VAS)
- •Provided written informed consent
排除标准
- •Coagulopathy
- •Local infection at the injection site
- •Known allergy to local anesthetics or magnesium sulfate
- •Severe cardiopulmonary disease [American Society of Anesthesiologists (ASA) ≥ IV]
- •Preexisting diabetic or other neuropathies
- •Chronic opioid use
- •Contraindication to spinal anesthesia
- •Cognitive impairment or inability to comprehend Visual Analog Scale (VAS)
研究组 & 干预措施
PENG Block Group
Assigned Interventions:
Procedure/Surgery: Pericapsular Nerve Group (PENG) Block An ultrasound-guided nerve block targeting articular branches of the femoral, obturator, and accessory obturator nerves. Performed under aseptic technique using a curved low-frequency ultrasound probe to visualize the iliopsoas plane and pubic ramus.
Drug: Bupivacaine (0.25%, 30 ml) Local anesthetic used to provide analgesia in nerve block. Drug: Magnesium sulfate (10%, 5 ml = 500 mg) Adjunct used to enhance analgesic efficacy of the block.
干预措施: Pericapsular Nerve Group (PENG) Block (Procedure)
Femoral Nerve Block Group
Assigned Interventions:
Procedure/Surgery: Femoral Nerve Block (FNB) An ultrasound-guided nerve block targeting the femoral nerve, performed with an in-plane ultrasound approach under sterile conditions, identifying the nerve lateral to the femoral artery.
Drug: Bupivacaine (0.25%, 30 ml) Local anesthetic used for nerve block. Drug: Magnesium sulfate (10%, 5 ml = 500 mg) Adjunct analgesic agent.
干预措施: Femoral Nerve Block (FNB) (Procedure)
结局指标
主要结局
Pain Score During Positioning for Spinal Anesthesia Using Visual Analog Scale (VAS)
时间窗: Immediately before spinal anesthesia (within 15 minutes post-block)
The Visual Analog Scale (VAS) will be used to assess pain intensity during positioning for spinal anesthesia. The VAS is a 10 cm line where 0 indicates no pain and 10 indicates the worst imaginable pain. The score will be recorded immediately before spinal anesthesia after performing either the PENG block or femoral nerve block.
Time to First Rescue Analgesia
时间窗: Within 24 hours postoperatively
The time (in hours) from the end of the nerve block to the first request for additional analgesia (nalbuphine 0.2 mg/kg IV) will be recorded for each patient.
次要结局
- Total Nalbuphine Consumption(24 hours postoperatively)
- Mean Arterial Pressure (MAP) Changes(From baseline up to 24 hours postoperatively)
- Patient Satisfaction Score(At 24 hours postoperatively)
研究者
Mohamed Khaled Radwan Ammar
Resident of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University
Ain Shams University