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临床试验/CTRI/2026/03/106054
CTRI/2026/03/106054尚未招募4 期

Comparative study of efficacy of Diclofenac and ketoprofen transdermal patches for postoperative pain relief in post LSCS patients.

Rahul Saxena1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2026年3月26日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
108
试验地点
1

研究概览

简要总结

This randomized controlled trial aims to compare the efficacy of diclofenac and ketoprofen transdermal patches for postoperative pain management in patients undergoing lower segment cesarean section (LSCS) under spinal anesthesia. Postoperative pain after cesarean delivery can delay maternal recovery, breastfeeding, and early mobilization. Transdermal NSAID patches provide a noninvasive and convenient method of analgesic delivery with controlled drug release and fewer gastrointestinal side effects.

A total of 108 patients aged 18–40 years, ASA grade II, scheduled for elective or emergency LSCS under spinal anesthesia will be enrolled and randomly allocated into two groups. Group K will receive a Ketoprofen 30 mg transdermal patch, and Group D will receive a Diclofenac 100 mg transdermal patch. The patch will be applied over the deltoid region immediately after delivery of the baby.

Pain intensity will be assessed using the Visual Analogue Scale (VAS). If the VAS score exceeds 4, intravenous paracetamol (10 mg/kg) will be administered as rescue analgesia. Hemodynamic parameters, including heart rate, systolic blood pressure, diastolic blood pressure, mean blood pressure, and oxygen saturation, will also be monitored. Adverse drug reactions, if any, will be recorded.

The primary objective of the study is to compare the analgesic efficacy of diclofenac and ketoprofen transdermal patches in post-LSCS patients, while secondary objectives include assessment of hemodynamic changes and adverse drug reactions associated with these patches.

The results of this study may help identify a more effective and convenient postoperative analgesic modality for cesarean section patients, improving maternal comfort and recovery.

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

  • Patients scheduled for elective or emergency lower segment cesarean section under subarachnoid blockade.
  • ASA grade II.

排除标准

  • Duration of surgery beyond 90 minutes having intra-op complications.
  • Failed spinal and inadequate spinal anesthesia.
  • Previous hypersensitivity to NSAIDs or any other drugs.
  • High-risk pregnancy with any previous cardiac, respiratory, renal, and liver disease or any coagulation disorders.

研究者

发起方
Rahul Saxena
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Rahul Saxena

GMC haldwani

研究点 (1)

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