A PROSPECTIVE COMPARATIVE RANDOMIZED CONTROL STUDY OF POST OPERATIVE PAIN MANAGEMENT IN ELECTIVE CESAREAN SECTION USING 5% LIGNOCAINE PATCH VS PARACETAMOL INFUSION
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
- Compare the postoperative analgesic efficacy of a transdermal Lignocaine 5% patch versus intravenous Paracetamol infusion in the immediate postoperative period
研究概览
简要总结
This study is a prospective double blind interventional trial comparing a transdermal 5 percent lignocaine patch with intravenous paracetamol infusion for postoperative pain relief in women undergoing elective lower segment cesarean section under spinal anesthesia. Eighty ASA physical status one and two parturients aged 18 to 40 years will be randomized into two equal groups; the lignocaine patch group will receive a 5 percent lidocaine patch applied one centimeter above the incision for 24 hours, and the paracetamol group will receive one gram intravenous paracetamol every eight hours for 24 hours, with diclofenac as rescue analgesia. Pain intensity will be assessed using the Visual Analog Scale at regular intervals up to 24 hours, maternal satisfaction and adverse effects will be recorded, and the main objective is to compare analgesic efficacy, rescue analgesic requirement, and safety between the two regimens using standard statistical tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients between 18 to 40 years of age, belonging to ASA Physical Status I & II, undergoing elective lower segment caesarean section (LSCS) with singleton pregnancies under spinal anaesthesia will be considered eligible.
排除标准
- •Not willing for the consent
- •History of any previous intraabdominal surgery
- •Known allergy or hypersensitivity to Lignocaine, Paracetamol, or any components of the study drugs.
- •Presence of chronic pain disorders or history of long-term analgesic use.
- •Patients with hepatic or renal dysfunction.
- •Presence of coagulopathy, local skin infection at the patch site, or other contraindications to regional anaesthesia.
- •Patients with intraoperative complications (e.g., conversion to general anaesthesia, excessive bleeding) affecting postoperative pain interpretation.
- •Patients unable to understand or comply with pain scoring systems (e.g., due to language barriers, cognitive impairment, or psychiatric illness).
结局指标
主要结局
Compare the postoperative analgesic efficacy of a transdermal Lignocaine 5% patch versus intravenous Paracetamol infusion in the immediate postoperative period
时间窗: 24 hours
次要结局
- Higher Maternal Satisfaction, Reduced need for rescue analgesia(First 24 Hours)
研究者
Dr Joseph Nixon Mavely
Datta Meghe Medical College