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临床试验/CTRI/2025/01/079185
CTRI/2025/01/079185已完成不适用

Efficacy of Lidocaine patch for postoperative pain relief after caesarean section: A double-blinded randomized controlled trial.

All India Institute of Medical Sciences Patna1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年2月2日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
To assess the analgesic effects of a 5% lignocaine patch compared to placebo patch in reducing postoperative pain intensity among women undergoing elective cesarean section deliveries using Numerical rating scale

研究概览

简要总结

Lidocaine is a local anaesthetic of the amide type which stabilises excitable membranes by inactivation of sodium channels. Its action on neuronal membranes prevents neuronal conduction. When applied topically in the form of patch, lidocaine produces a local analgesic effect. Lignocaine patch has a dual mode of action: the pharmacological action of lidocaine diffusion and the mechanical action of the hydrogel patch that protects the hypersensitive area. The lidocaine contained in the patch diffuses continuously into the skin, providing a local analgesic effect.

Caesarean section deliveries are one of the most common surgical procedures worldwide, offering a safe alternative for childbirth in cases where vaginal delivery poses risks to the mother or the baby.  Inadequate pain relief not only diminishes the mother’s comfort but also impedes her ability to care for her newborn and recover swiftly. For pain control use of opioid can be a major risk factor for PONV and post-operative sedation. The use of 5% lignocaine patch may contribute to lesser analgesic consumption and early recovery in mothers  undergoing caesarean section delivery under spinal anaesthesia.

This study aims to evaluate the potential postoperative analgesic effects of the 5% lignocaine patch in women undergoing cesarean section under spinal anesthesia and it’s utility as a valuable adjunct in the multimodal approach to postoperative pain management.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator 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

  • Women between 18 years to 40 years of age.
  • Scheduled for elective cesarean section.
  • American Society of Anesthesiologist physical status
  • Gestational age more than 32 weeks.
  • Body Mass Index (BMI) less than or equal to 30.

排除标准

  • Known allergy or hypersensitivity to lidocaine or any component of the lidocaine patch.
  • Pre-existing chronic pain conditions.
  • Contraindication for neuraxial anaesthesia.

结局指标

主要结局

To assess the analgesic effects of a 5% lignocaine patch compared to placebo patch in reducing postoperative pain intensity among women undergoing elective cesarean section deliveries using Numerical rating scale

时间窗: At 24 hours

次要结局

  • To assess the analgesic effects of a 5% lignocaine patch compared to placebo patch in reducing postoperative pain intensity among women undergoing elective cesarean section deliveries using Numerical Rating Scale.(at 2, 6, 12 and 36 hours.)
  • The administration of a 5% lignocaine patch will result in reduced opioid consumption compared to conventional intervention among women undergoing cesarean section deliveries.(At 24 hours)
  • To find out patient’s impact on sleep due to pain using Daily Sleep Interference Scale .(At 24 hours)
  • To find out the incidence of post operative nausea and vomiting with the use of 5% lidocaine patch using 4-point rating .(At 24 hours)

研究者

发起方
All India Institute of Medical Sciences Patna
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Purnaa Mandal

All India Institute of Medical Sciences Patna

研究点 (1)

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