To evaluate efficacy of hyaluronidase as an adjuvant to bupivacaine on the quality of brachial plexus block via sonar guided supraclavicular approach: A prospective randomized comparative study in department of Anesthesia ,sms medical college, jaipur .
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean of Onset of sensory block (minutes)
研究概览
简要总结
Then 60 Patients will be randomly allocated into two equal groups each of 30 patients: in group I, patients received 25 ml plain bupivacaine 0.5% by single-injection technique while in group II, patients received 15 ml volume [15 ml 0.5% bupivacaine plus 5 ml 0.9% normal saline containing 500 IU (100 IU/ml) hyaluronidase total of 20 ml by single-injection technique. Hyaluronidase will be prepared by diluting the vial of hyaluronidase (1500 IU) in 15 ml normal saline 0.9%. and its 5 ml volume is mixed with bupivacaine in group II The local anesthetic solution will be prepared by an anesthesiologist . Monitoring of all parameters will be done by an anesthesiologist . Time of onset of sensory and motor blocks, success rate of block will be noted along with duration of motor block , the total duration of analgesia and side effects if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Undergoing elective upper limb surgeries.
- •Patients willing to participate with written informed concent Patient of either sex All Adults American Society of Anesthesiologists(ASA) grade 1 and 2 Body weight between 40-70 kg.
排除标准
- •Case with sepsis, bacteremia or skin infection of local site History of severe hypovolemia, anemia and compromised Renal ,cardiac and respiratory system Patient allergic to drugs used for study.
- •Failure of supraclavicular block cases in which general Anesthesia will be required.
结局指标
主要结局
Mean of Onset of sensory block (minutes)
时间窗: Baseline, | 2 min | 5 min | 10 min | 15 min | 30 min
Mean of Onset of motor block (minutes) Mean Duration of motor block (minutes) Proportion of Rate of success of block Mean Duration of analgesia (minutes) Mean Hemodynamic parameters Proportion of cases having Complication( if any)
时间窗: Baseline, | 2 min | 5 min | 10 min | 15 min | 30 min
次要结局
- Mean of Onset of sensory block (minutes)(Mean of Onset of motor block (minutes) Mean Duration of motor block (minutes) Proportion of Rate of success of block Mean Duration of analgesia (minutes) Mean Hemodynamic parameters Proportion of cases having Complication( if any))
研究者
Dr Sonali Beniwal
SMS medical college