Pericapsular Nerve Group Block vs Low Volume Interscalene Brachial Plexus Block for Shoulder Arthroscopy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Incidence of phrenic nerve block
研究概览
简要总结
This study aims to compare PENG block and LV-ISBP block in the incidence of phrenic nerve block, duration of postoperative analgesia, time to first analgesic request (VAS > 30 mm), pain scores, and side effects.
详细描述
This randomized, controlled, double-blinded trial will be conducted in a Cairo University hospital.On arrival of the patients in the regional anesthesia room, they will be secured with a 20-gauge intravenous cannula. Monitoring will include ECG, non-invasive arterial blood pressure, and pulse oximetry (SpO2).
Before receiving the blocks, patients will be randomly assigned to one of the two study groups for diaphragmatic movement assessment:
The diaphragmatic excursion will be measured in the supine position before the block and after surgery by a blinded operator. A curvilinear ultrasound probe (5-7 MHz) will be placed at the subcostal area in the anterior axillary line, below the costal margin of the eighth and ninth ribs. The probe will be directed medially, cephalad, and dorsally to make the ultrasound beam reach the posterior third of the diaphragm perpendicularly. The probe will then be scanned along the long axis of the intercostal spaces, using the liver as the acoustic window on the right side and the spleen as the acoustic window on the left side. The M-mode sampling line will be positioned perpendicularly to the diaphragm, and the diaphragmatic excursions could be measured during quiet and deep breathing. The distance between the resting expiratory position and the maximum deep inspiration position will be measured. The measurement will be repeated three times, and the average value will be taken.
After measurement of diaphragmatic excursion, patients will receive either a PENG block or an LV-ISBP block before induction of general anesthesia, and to achieve double blinding, patients will receive the block by consultant anesthesiologists who have experience in regional anesthesia. Another doctor not involved in the block procedure will evaluate the patient intraoperatively and postoperatively.
PENG block group (n = 40): this group will receive an ultrasound-guided pericapsular nerve group block for the shoulder with a total volume of 20 mL and 0.5% 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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for shoulder arthroscopy
- •American Society of Anesthesiologists (ASA) status I and II
- •Ages between 18 and 60 years.
排除标准
- •Coagulopathy
- •Infection at the injection site.
- •Allergy to local anesthetics
- •Severe cardiopulmonary disease (≥ASA III)
- •Diabetic or other neuropathies
- •Motor disorders
- •Patients receiving opioids for chronic analgesic therapy.
- •Inability to comprehend visual analogue scale (VAS).
结局指标
主要结局
Incidence of phrenic nerve block
时间窗: 24 hours
Incidence of phrenic nerve block
次要结局
- First analgesic request(24 hours postoperative)
- Total morphine requirements(24 hours)
- Type and time of surgery(up to 4 hours)
- Visual analogue pain score(24 hours postoperatively.)
研究者
Nagy Malak , MD
Lecturer anesthesia cairo university
Cairo University