A STUDY ON THE EFFECTIVENESS OF LIDOCAINE PATCH VERSUS EUTECTIC MIXTURE OF LOCAL ANAESTHETICS (EMLA) CREAM IN PREVENTING PAIN DURING EPIDURAL NEEDLE INSERTION: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Analgesic efficacy assessed using 10-point Visual Analogue Scale (VAS)
研究概览
简要总结
This study aims to compare the effectiveness of Lidocaine patch versus EMLA cream in preventing pain during epidural needle insertion. Epidural needle insertion using a 16G Tuohy needle is often associated with discomfort and pain. Topical anaesthetic agents may help reduce this pain and improve patient comfort.
This is a single blinded randomized controlled trial conducted in the Department of Anaesthesiology at Aarupadai Veedu Medical College and Hospital Puducherry. Eighty patients aged 18 to 65 years belonging to ASA I II and III undergoing elective lower abdominal pelvic or lower limb surgeries requiring epidural anaesthesia will be included. Participants will be randomized using block randomization into two groups of forty each.
Group A will receive transdermal Lidocaine patch approximately ten hours before surgery. Group B will receive EMLA cream applied thirty minutes before surgery with occlusive dressing. The primary outcome will be analgesic efficacy assessed using ten point Visual Analogue Scale immediately after epidural needle insertion. The secondary outcome will be subjective pain assessment using Wong Baker Scale at the time of needle insertion.
The results of this study will help determine whether Lidocaine patch can be used as an effective alternative to EMLA cream in reducing pain during epidural needle insertion.
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 65.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA I, II, III Patients undergoing Lower abdominal / Pelvic / Lower limb surgeries requiring Epidural Anaesthesia.
排除标准
- •Patient refusal to participate in the study Known allergy to local anaesthetics Contraindication to epidural anaesthesia Patients requiring rescue analgesia with 2% lignocaine infiltration during epidural needle insertion.
结局指标
主要结局
Analgesic efficacy assessed using 10-point Visual Analogue Scale (VAS)
时间窗: Within five minutes after epidural needle insertion
次要结局
- Subjective assessment of pain using Wong Baker Scale(At the time of epidural needle insertion)
研究者
Chetan Jain Dilip
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL PUDUCHERRY
