Efficacy and Safety profile of 2% Lignocaine versus 0.5% Ropivacaine as local anaesthetic agent in middle ear surgeries in a tertiary care centre Chengalpattu district - A Single Blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative Analgesia using Visual Analog Scale
研究概览
简要总结
This study is a randomized, single blind, single-centre trial comparing the efficacy and safety profile of 0.5% Ropivacaine and 2% Lignocaine as local anaesthetic in middle ear surgeries in 80 patients that will be conducted in Single tertiary care center in Chengalpattu district, India. The primary outcome measure will be duration of Postoperative analgesia. The secondary outcomes will be onset of action, duration of action. time of 1st rescue analgesic given postoperatively, surgeon satisfaction, patient satisfaction, hemodynamic stability, adverse effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with middle ear pathologies planned for surgeries like tympanoplasty, Stapedectomy, mastoidectomy, myringotomy, grommet insertion.
- •Patients those who provided informed consent to participate in the study.
排除标准
- •1.Previous history of Allergic reactions to Amide type local anaesthetics 2.History of severe cardiac arrythmias, severe liver or renal disorders, neurological disorders 3.Pregnancy and breastfeeding mothers
- •Cognitive barriers.
结局指标
主要结局
Postoperative Analgesia using Visual Analog Scale
时间窗: Every hour till first 8 hours during the postoperative recovery period, Pain will be assessed using Visual Analog Scale
次要结局
- onset of action of local anaesthesia by pin prick method(time calculated from completion of administration of local anesthesia to onset of anesthesia)
- duration of action of local anaesthesia assessed by return of sensation in targeted area(in first 8 hours of postoperative period)
- time of 1st rescue analgesic given postoperatively(in the first 8 hours of postoperative period)
- surgeon satisfaction by Likert scale
- patient satisfaction with LOWA satisfaction with anesthesia scale
- hemodynamic stability by recording the vitals during the intraoperative period
- adverse effects like Nausea, vomiting, Bradycardia, Hypotension, Dizziness, Confusion, Respiratory depression, seizures, Cardiac arrest will be recorded
研究者
Swathi S
Karpaga vinayaga institue of medical sciences and research centre