Comparison of Superior Brachial Trunk Block and Peri-capsular Nerve Group Block of Shoulder Joint in Arthroscopic Shouldersurgery: A Randomized Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare Cumulative opioid
研究概览
简要总结
Early postoperative pain immediately following shoulder surgery is a major concern and cause of distress for patients and orthopedic surgeons. Adequate pain control is vital for all aspects of the patient’s recovery, hence regional anaesthesia plays an important role in decreasing the pain following shoulder surgeries. Superior Brachial trunk block a variant of conventional interscalene block is found to be non inferior to latter in providing adequate post operative analgesia. However superior brachial trunk block like interscalene block is associated with incidence of hemi diaphragmatic paresis due to local anaesthetic spread around the phrenic nerve. PENG block around shoulder joint is a new motor sparing block that causes only sensory blockade that needs to be evaluated.
Standard Pre-Anesthetic Check Up will be done preoperatively and no premedication will be given. Informed and written consent will be taken from the patients while educating them about PCA machine and 11-points numerical rating scale for pain. When the patient arrives pre-op holding area: Baseline ipsilateral dome Diaphragmatic Ultrasound (T1) will be done for diaphragmatic excursion. Patient is randomly allocated via a sealed envelope to get either a superior brachial trunk block or PENG block around shoulder. In the operating room: standard monitoring will be done (HR, RR, NIBP, SpO2, EtCo2). Depending on the group to which the patient will be allocate either superior brachial trunk block or PENG block around shoulder will be given. Under aseptic conditions high frequency linear transducer will be placed over the interscalene region and superior brachial trunk block will be carried out For patients allocated to PENG block round shoulder group, high frequency linear transducer will be placed longitudinally between coracoid process and head of humerus and drug will be injected between subscapularis tendon below and deltoid muscle above. Drug to be used: 0.5% ropivacaine 15ml in both the blocks. Drug injected time will be taken as T0. At T20 motor blockade will be assessed. Patient will be induced with fentanyl 2mcg/kg, propofol 1.5 – 2 mg/kg, atracurium 0.5mg/kg followed by tracheal intubation. Maintenance: sevoflurane with air and oxygen. Intra operatively bolus of fentanyl 0.5mcg/kg will be given if heart rate and blood pressure increase by > 20% of baseline. Complications if any will be managed as per standard protocol. At the end of surgery reversal will be done with neostigmine and glycopyrrolate followed by extubation, and the patient will be shifted to PACU. Post operatively: USG will be done to find out diaphragmatic excursion. PCA pump will be attached to the patient that delivers 25mcg of fentanyl on demand with a lockout interval of 15 mins, with no basal dose. Inj PCM 10-15 mg/kg 6 hourly will be supplemented and injection ketorolac 0.5mg/kg iv 12 hourly as a part of multimodal analgesia, and if patient complains of pain more than 4/10 on VAS then 75-100 mcg/kg of morphine will be given. After 24 hrs. PCA pump will be disconnected and total fentanyl consumed will be noted. In addition, rescue opioids given if any are also noted, pain according to VAS from 0 – 10 is noted, patient satisfaction, surgeon satisfaction and complications if any will be noted down. The collected data will be analyzed using SPSS 20.1 (IBM Corp). Parametric variables will be described as mean ± standard deviation and qualitative variables were described as number (percentage) and as median and range.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA I to III patients.
- •Age group of 18-80 3) Scheduled for elective unilateral arthroscopic surgery.
排除标准
- •Patients who refused to participate in the study.
- •Patients with a history of cardiac, renal, or hepatic disease
- •Patients with Pre-existing neurologic deficits or neuropathy affecting the brachial plexus
- •Patients with Contraindications to peripheral nerve block
- •Patients with known allergy to local anaesthetics.
结局指标
主要结局
To compare Cumulative opioid
时间窗: 24hrs after surgery.
between superior brachial trunk block and PENG block around shoulder with a prespecified non inferiority level of 15%.
时间窗: 24hrs after surgery.
consumption at 24hrs, after arthroscopic shoulder surgery
时间窗: 24hrs after surgery.
次要结局
- To compare between the two groups the following parameters:(1) 24hr pain intensity on an 11-point numerical rating score)
