The Efficacy of Hyaluronidase as an Adjuvant to Bupivacaine in Ultrasound-guided Erector Spinae Plane Block in Percutaneous Nephrolithotomy. Randomized Double-blind Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Postoperative pain score by numeric rating scale (NRS)
研究概览
简要总结
Evaluation of the postoperative pain via numeric rating scale (NRS) through erector spinae plane block (ESPB) by adding hyaluronidase as an adjuvant to bupivacaine on the postoperative analgesia in erector spinae plane block.
详细描述
- During mask preoxygenation, patients baseline hemodynamic parameters will be recorded regarding blood pressure and heart rate.
- General anesthesia will be standardized for all patients with :
2 µg / kg fentanyl, 2 mg/kg 2% propofol then 0.5 mg/kg atracuriam will be administered for muscle relaxation.
- Patients will be intubated and lungs mechanically ventilated to maintain end-tidal CO2 between 30 to 35 mmHg. Fresh gas flow oxygen in air 30-40% at a rate of 3 L/min .
- The patients will receive 1.2 % MAC of isoflurane .
- Top- up doses of 0.15 mg/kg atracurium will be given to maintain intraoperative muscle relaxation.
- In all patients , insufflation will be under pressure of 15 mmHg or less .
- The surgical time in all surgical procedures will be fixed in the range of two hours and by the same surgical team.
After the patient will be generally anesthesized and before starting the operation , the erector spinae plane block will be performed .
• Patients will be randomly allocated to one of the two groups and the study will be double blinded where neither the operator nor the patients know which group will be . The syringes will be prepared by the other investigators.
. In group l : ESPB with bupivacaine 0.25% (30 ml volume : 15 ml saline Plus 15 ml plain bupivacaine ) .
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, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective percutaneous nephrolithotomy
- •Age: adult patients between 20 - 65 years old.
- •Gender: Both male and female.
- •ASA Class: I and II.
排除标准
- •Refusal of patient.
- •Patients ASA class III and IV.
- •Chronic kidney disease grade lll & lV .
- •Pregnancy and lactation.
- •Allergy to any of the study medications.
- •Addicts and drug abusers.
- •Patients taking corticosteroids or any cardio - active drugs.
- •Severe coagulopathy ( INR >3 or platelets <70*10) .
- •Fever or sepsis.
- •Local infection at site of the injection.
研究组 & 干预措施
Group 1: ESPN with bupivacain 0.25%
ESPN with (30 ml volume : 15 ml saline Plus 15 ml plain bupivacaine ) .
干预措施: Ultrasound guided erector spinae plane block (Procedure)
Group II : ESPN with bupivacaine 0.25 % and hyalurinidase
ESPN with ( 14 ml saline & 15 ml plain bupivacaine 0.25% Plus 150 units of hyaluronidase which is equal 1 ml ) .
干预措施: Ultrasound guided erector spinae plane block (Procedure)
结局指标
主要结局
Postoperative pain score by numeric rating scale (NRS)
时间窗: Started measuring on admission to PACU ( 0 time) and 2, 4, 6 and 24 hours following admission
Pain intensity will be estimated by a numeric rating scale (NRS) (0 = no pain, 10 = worst imaginable pain)
次要结局
未报告次要终点
研究者
Emad Mohamed Ahmed Abdelhafez
Lecturer of Anesthesia, Critical Care and Pain Management
Kasr El Aini Hospital