Comparison between Bupivacaine v/s Bupivacaine plus Nalbuphine in supraclavicular brachial plexus block: Double blind randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To Compare effect of Inj Nalbuphine as an adjuvant to Inj Bupivacaine against Inj Bupivacaine alone in terms of
研究概览
简要总结
Written informed consent will be taken in the local language. Patient will be randomized using computer generated random number sequence methods in two groups Group A- Injection Bupivacaine(0.375%)29cc +Injection Normal saline 1cc Group B-Injection Bupivacaine(0.375%)29cc +Injection Nalbuphine(10mg)1cc. After shifting the patient to the pre operative care room, 18 G intravenous catheter is inserted on non operative hand by an anaesthesia resident. Standard monitoring will be applied which includes Non invasive blood pressure(NIBP),Electrocardiographic monitoring,Heart Rate,Pulse oximeter(SPO2). Local sensitivity testing will be done. The study drug should be prepared and coded by an anaesthesiologist not involved in the study. Anaesthesiologist other than Principal investigator will perform the brachial plexus block and PI will be, responsible for monitoring of the patient. So, PI will remain blinded for the study.The onset and time to reach peak sensory & motor blockade, haemodynamic changes, regression time for sensory and motor block, duration of analgesic effect, side effect will be recorded by PI.In the operation theatre, supraclavicular block will be performed with the aid of Nerve locator (Stimuplex by B. Braun Melsungen, Germany). A 22-gauge insulated needle (Pole injector), 50 mm long, will be connected to the other pole with an alligator clamp. The plexus will be located using the supraclavicular approach. The current will be initially set to deliver 1.0 milli amperes at 2Hz stimulation frequency.End of the injection will be taken as Time ’O’. Immediately after the block, sensory and motor characteristics of blockade, hemodynamic variables, SpO2 shall be assessed by the Principal Investigator at 1,5,10,20,30 minutes and then at hourly interval till offset of sensory and motor blockade and then at four hourly interval for 24 hours. Sensory block will be assessed by pinprick test using the blunt end of a 23-gauge needle at each minute after completion of drug injection in the dermatomal areas corresponding to median nerve, ulnar nerve, radial nerve and musculocutaneous nerve till complete blockade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 58.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anesthesiologists (ASA) physical status I to II of either gender 2) Age: 18–58 years 3) Patients scheduled for elective forearm and hand surgeries in orthopaedic operation theaters.
排除标准
- •Patients with clinically significant coagulopathy 2) Infection at the injection site 3) Allergy to local anesthetics 4) Refusal to technique 5) Patients taking psychotropic medications.
结局指标
主要结局
To Compare effect of Inj Nalbuphine as an adjuvant to Inj Bupivacaine against Inj Bupivacaine alone in terms of
时间窗: 24 hrs
1. The onset of sensory and motor blockade.
时间窗: 24 hrs
2. Duration of sensory and motor blockade.
时间窗: 24 hrs
3. Duration of analgesia (first request for analgesic)
时间窗: 24 hrs
次要结局
- To assess the hemodynamic parameters in two groups in terms of(1. Change in Blood pressure (BP).)