Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Onset of motor block
研究概览
简要总结
The investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of block and duration of analgesia, so that the investigators can choose the better adjuvant for the investigators routine practice of regional anesthesia.
详细描述
Ropivacaine is a newer local anesthetic which is structurally related to bupivacaine, but has fewer side effects. It is more cardio stable than bupivacaine, but the onset of action is delayed and the duration of action is shorter than bupivacaine making its use during regional anesthesia less preferable to many anesthesiologists. Steroids like dexamethasone, or alpha-2 agonists like dexmedetomidine are being studied as adjuvants to ropivacaine for brachial plexus block to improve its anesthetic properties and have shown favorable outcome in terms of shortening the onset of block and prolonging the duration of action. But no study has been done to compare their effects. So in this study the investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of block and duration of analgesia, so that the investigators can choose the better adjuvant for the investigators routine practice of regional anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of American Society of Anesthesiologists Physical Status I and II undergoing elective upper limb surgery under supraclavicular brachial plexus block
排除标准
- •Patient's refusal to participate
- •Patients weighing less than 40 kg
- •Allergy to study drugs
- •Infection at the site of injection
- •Patients with preexisting neurological deficit
- •Patients with diabetes mellitus
- •Patients on steroids preoperatively
- •Patients with bleeding disorder or coagulopathy
- •Abnormalities in ECG like AV block or symptomatic bradycardia
- •Patients receiving adrenoreceptor agonist or antagonist therapy preoperatively
- •Requirement of conversion to general anesthesia due to inadequate block
研究组 & 干预措施
Block with Ropivacaine and Normal saline
Patients will receive brachial plexus block with 20 ml 0.5% ropivacaine with 1ml normal saline: Total volume 21 ml
干预措施: Ropivacaine and Normal saline (Drug)
Block with Ropivacaine and Dexamethasone
Patients will receive brachial plexus block with 20ml 0.5% ropivacaine with 4mg (1ml) dexamethasone: Total volume 21 ml
干预措施: Ropivacaine and Dexamethasone (Drug)
Block with Ropivacaine and Dexmedetomidine
Patients will receive brachial plexus block with 20ml 0.5% ropivacaine with 50mcg (1ml) dexmedetomidine: Total volume 21 ml
干预措施: Ropivacaine and Dexmedetomidine (Drug)
结局指标
主要结局
Onset of motor block
时间窗: every 3 minutes until 45 minutes after injection of drug
Motor block will be evaluated by thumb flexion/ opposition (median nerve), thumb extension (radial nerve), finger abduction (ulnar nerve) and elbow flexion with forearm in full supination (musculocutaneous nerve) on a 3-point scale for motor function: 0 - normal motor function, 1. - reduced motor strength but able to move, 2. - complete motor block. Complete motor block will be defined as grade 2 motor block in 3 or more nerve territories.
Duration of analgesia
时间窗: Up to 24 hours after onset of block
Onset of sensory block
时间窗: every 3 minutes until 45 minutes after injection of drug
Sensory block in the territories of median nerve (palmar surface of index finger), ulnar nerve (palmar surface of little finger), radial nerve (dorsal surface of first web space/ thumb) and musculocutaneous nerve (lateral side of volar surface of forearm) will be assessed by pinprick test using a 3-point scale: 0 - normal sensation, 1. - loss of sensation of pinprick (analgesia), 2. - loss of sensation of touch (anaesthesia). Complete sensory block will be defined as grade 2 sensory block in 3 or more nerve territories.
次要结局
- Duration of motor block(Up to 24 hours after onset of block)
- Incidence of side effects of drugs(Forty-eight hours following the injection of local anesthetics)
- Duration of sensory block(Up to 24 hours after onset of block)
研究者
Parineeta Thapa
Dr
B.P. Koirala Institute of Health Sciences