Comparison of Block Characteristics of An Equal Mixture of 2% Lidocaine with Adrenaline And 0.5% Ropivacaine Versus 0.5% Ropivacaine Alone for Ultrasound Guided Axillary Brachial Plexus Block: A Double-Blinded Randomised Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Comparison of ONSET TIME of complete conduction blockade in both the groups (defined in minutes, as the time from end of needling to the time required to reach a minimum score of 14/16 using a sensorimotor composite scale.)
研究概览
简要总结
Regional anaesthesia, particularly Axillary brachial plexus block (ABPB) using ultrasound guided technique is commonly used for orthopaedic surgeries below the elbow . Use of appropriate drugs can determine the intraoperative effectiveness and postoperative analgesia, leading to improved patient care as well as better utilization of resource setting. Recent studies have advocated the use of mixtures of lidocaine with adrenaline and ropivacaine over ropivacaine alone in various nerve blocks, we intend to compare it in ABPB for below elbow surgical procedures.
Patients will be divided in two groups with one receiving equal mixture of lidocaine with adrenaline and ropivacaine while the other group will receive ropivacaine only for ultrasound guided ABPB. Both drugs have certain advantages, Lidocaine offers a quick onset, ropivacaine extends the duration of postoperative analgesia, maintaining pain relief for several hours after the procedure. Therefore the duration of onset time of blocks of both groups will be compared.
A total of 62 patients will be divided in two groups with 31 each for a randomized double-blinded controlled trial to compare the blocks in two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients (18-65 years) in need of upper limb anaesthesia for undergoing orthopaedic surgeries at elbow and below under axillary brachial plexus block.
- •American Society of Anaesthesiologists I and II physical status.
- •Body weight within BMI less than or 30 kg/m².
排除标准
- •Allergy to local anesthetics.
- •Pre-existing neuropathy or brachial plexus injury.
- •Coagulopathy or anticoagulant use.
- •Pregnancy or lactation.
- •Patient refusal.
- •Known case of Renal failure.
- •Known case of Hepatic failure.
- •Evidence of infection at axillary area Patients unable to abduct the operative arm Patients receiving general anaesthesia.
结局指标
主要结局
Comparison of ONSET TIME of complete conduction blockade in both the groups (defined in minutes, as the time from end of needling to the time required to reach a minimum score of 14/16 using a sensorimotor composite scale.)
时间窗: at regular intervals of 2 minutes, till a composite sensorymotor score of 14/ 16 is achieved
次要结局
- Durantion of Sensory Block
- Duration of motor block(defined in hours,as the tume from inability to perform specific voluntary motor functions of upper limbs like wrist flexion or extension/ thumb adduction/ elbow flexion to the point where first voluntary movements are observed.)
- Success rate of block (need for supplementation or conversion to general Anaesthesia)(inability to achieve a composite sensorymotor score of less than 14 in 30 mins.)
- To assess any adverse effects
研究者
Krishna Kanhaiya
Northern Railway Central Hospital, New Delhi