Randomized controlled trial to look into effect of topical 2% lidocaine spray in reducing pain prior to intradermal lidocaine for local anaesthesia in patients undergoing respiratory procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- To compare the pain scores during intradermal lidocaine infiltration between two study groups i.e. 2%lidocaine spray vs Normal saline spray by using FACES score.
研究概览
简要总结
The aim of this study is to assess whether there is a reduction in pain perception in patients while receiving an additional skin surface lidocaine spray just prior to intradermal lignocaine infiltration in patients undergoing respiratory procedures. Patients will be randomized into two arms (2% lidocaine spray arm and Normal saline spray arm). Pain perception in each arm following the intradermal lidocaine infiltration will be assessed with FACES pain score. Additionally, we will look into incidence of pain related adverse events like vasovagal syncope in both study groups. For this randomized controlled trial, patients will be recruited from outpatients and in patients under respiratory medicine department. Study will be conducted in bronchoscopy suite /respiratory medicine treatment room /respiratory medicine ward of CMC Vellore. It will be conducted as an Placebo controlled randomized controlled study. The main primary outcome is patient Score rated by FACES pain scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Consecutive patients undergoing respiratory diagnostic and therapeutic procedures requiring administration of intradermal ligniocaine injection and Image guided diagnostic and therapeutic pleurocentesis ,Chest drain insertion, medical Image guided closed pleural biopsy thoracoscopy during study period will be considered eligible for inclusion if they are 1.Aged above 18 years 2.Hemodynamically stable.
排除标准
- •1.No consent 2.Documented history of lignocaine toxicity 3.Pregnancy.
结局指标
主要结局
To compare the pain scores during intradermal lidocaine infiltration between two study groups i.e. 2%lidocaine spray vs Normal saline spray by using FACES score.
时间窗: Baseline
次要结局
- 1. To compare the percentage of proportion of patients in each arm who required 2nd or more additional dose of local anesthesia to complete the procedure(2.To determine pain related adverse events(vasovagal syncope ))