Effect of Addition of Cisatracurium to Lidocaine VS Plain Lidocaine for Intravenous Regional Anesthesia, a Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Time to onset of Sensory blockade.
研究概览
简要总结
The goal of this Randomized Control Trial is to compare the effects of addition of cisatracurium to lignocaine for IVRA Vs. Plain lignocaine in All ASA physical status I & II patients between 20 to 55 years of age, scheduled for elective hand surgery (carpal tunnel, trigger finger, tendon release, fracture reduction and tendon repair). The main question[s] it aims to answer are: • Does addition of Cisatracurium to plain lignocaine improve the overall quality of anesthesia? • Does use of cisatracurium lead to improved postop analgesia and decreased parenteral analgesic requirements? Participants will be Forty-four patients undergoing elective hand surgery during IVRA randomly assigned to two groups of 22 patients each. All demographic details (age, gender, body weight) will be noted, all will be briefed about visual analogue score (0 to 10) for pain. Group 1 (control group) will receive lidocaine 2% diluted with saline, group 2 (cisatracurium group) will receive cisatracurium plus lidocaine 2% diluted with saline. A standard technique would be employed for IVRA. The following parameters to be assessed: onset and offset of sensory and motor block, Intra-operative pain at 5, 10, 20, 30 minutes after tourniquet application by using visual analogue score (VAS), and postoperative pain using visual analogue score (VAS) measured at 5-minute,1, 2, 4, 8 hours postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All ASA physical status I & II patients between 20 to 55 years of age, scheduled for elective hand surgery
排除标准
- •Patients with Raynaud disease, sickle cell anemia, or a history of allergy to any drug to be used.
- •Also, patients who had bleeding tendency, on anticoagulant or antiplatelet therapy, significant cardiovascular, peripheral vascular, or neurological disease.
研究组 & 干预措施
Plain Lignocaine group
Group of participants receiving only plain lignocaine for IVRA
干预措施: Lignocaine (Drug)
Cisatracurium group
Group of participants receiving plain lignocaine and cisatracurium combined for IVRA
干预措施: Cisatracurium Besylate (Drug)
结局指标
主要结局
Time to onset of Sensory blockade.
时间窗: 1-5 min.
Sensory block will be assessed by pinprick in the dermatomal sensory distribution and time noted for complete sensory blockade.
Time to onset of Motor Blockade
时间窗: 2-7 min.
Motor block will be assessed by asking the subject to flex and extend his/her wrist and fingers, every 30 seconds and time to be noted till inability to flex or extend the wrist and fingers is confirmed and time noted.
Intraoperative Pain Scoring
时间窗: 5-45 min.
The severity of intraoperative pain will be assessed using 10 point VAS (Visual Analogue Score) with 1 being no pain and 10 being the worst possible pain at 5, 10, 20, 30 minutes after tourniquet application.
Regression of sensory blockade
时间窗: 2-10 min post deflation.
Sensory blockade regression time (the time elapsed from tourniquet deflation to recovery of complete sensation in all dermatomes, determined by pinprick test) , will be noted.
Regression of motor blockade
时间窗: 2-10 min post deflation
Motor block regression time (the time elapsed from tourniquet deflation until regaining of flexion and extension of wrist and fingers) will be noted.
Postop Pain scoring
时间窗: 5 minutes post deflaton till 8 hours post deflation.
Postoperative pain will be assessed by VAS at 5 minutes after tourniquet deflation and at 1, 2, 4, 8 hours postoperatively.
Time to first analgesic request post operatively.
时间窗: 1 hour - 8 hours post deflation.
The first analgesic dose requirement time will also be noted (the time elapsed from tourniquet release until first request for analgesic medication postoperatively)
Side Effects
时间窗: From onset of blockade to 8 hours post operatively.
Incidence of side effects such as tinnitus, dizziness, convulsions, gastric discomfort, muscle weakness and bleeding tendency will be recorded intraoperatively as well as during recovery from blockade.
次要结局
未报告次要终点
研究者
Muhammad Ilyas
Assistant Professor
Watim Medical & Dental College