CTRI/2025/03/082476招募中不适用
A Randomised double-blind controlled trial to compare the block efficacy, postoperative analgesia requirements and safety profile between 0.5 percent Ropivacaine with 90mcg Buprenorphine and 0.5 percent Levobupivacaine with 90mcg Buprenorphine in adult patients undergoing upper limb orthopaedic surgeries with ultrasound guided Supraclavicular Brachial Plexus Block anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Time required for first rescue analgesia
研究概览
简要总结
This study is to evaluate and compare the efficacy and safety profile between 20ml 0.5% Levobupivacaine with 90mcg Buprenorphine and 20ml 0.5% Ropivacaine with 90mcg Buprenorphine when used in Ultrasonography (USG) guided supraclavicular block in adult patients undergoing upper limb orthopaedic surgeries. There is however paucity of data comparing Buprenorphine at mentioned doses directly between Levobupivacaine and Ropivacaine, especially from Indian sub-continent and therefore this study is planned to research the same.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •American society of Anaesthesiologists (ASA) physical status I/II patients
- •Patients weight more than 40 kg
- •Patients scheduled for emergency, semi emergency or elective upper limb orthopaedic upper limb (elbow, forearm and hand) surgery.
- •Patients willing to take part in the study.
- •Haemodynamically stable patient with HR more than 60/min, MAP more than 60mmHg.
排除标准
- •Patients refusing to voluntarily participate in the study
- •Pre-existing peripheral neuropathy of upper limb
- •Patients with Bleeding disorders
- •Patients with infection at injection site
- •Patients with pneumothorax
- •Patients on adrenoreceptor agonist or antagonist therapy
- •History of severe cardiac disease
- •History of respiratory disease
- •Pregnancy
- •Known hypersensitivity to the study drugs.
结局指标
主要结局
Time required for first rescue analgesia
时间窗: 24 hours
次要结局
- Haemodynamic stability, sensory and motor block(3 hours)
研究者
Dr KABILAN R
MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES,SEVAGRAM,WARDHA
研究点 (1)
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