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临床试验/NCT07379762
NCT07379762已完成4 期

Comparison of Intramuscular Versus Rectal Diclofenac Sodium in Post Caesarean Pain Relief

CMH Multan Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月1日最近更新:
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Postoperative pain

研究概览

简要总结

The goal of this clinical study is to find out which way of giving diclofenac sodium provides better pain relief after a planned cesarean section: an injection into the muscle or a suppository given through the rectum. Diclofenac is a commonly used pain-relieving medicine after surgery.

Women often experience moderate pain after a cesarean section, and effective pain control helps with early movement, breastfeeding, and overall recovery. Different methods of giving the same medicine may work differently and may affect how comfortable patients feel after surgery. This study compares these two methods to see which one reduces pain more effectively.

Researchers will compare post-operative pain levels in women who receive intramuscular diclofenac with those who receive rectal diclofenac after elective cesarean section.

The main questions this study aims to answer are:

  • Does intramuscular diclofenac provide better pain relief than rectal diclofenac after cesarean section?
  • Is there a difference in the need for additional (rescue) pain medicine between the two groups?

Participants will be women aged 20 to 45 years who are undergoing a planned cesarean section at term. A total of 60 women will take part in the study. They will be randomly assigned to one of two groups:

  • One group will receive diclofenac as an intramuscular injection every 8 hours for the first 24 hours after surgery.
  • The other group will receive diclofenac as a rectal suppository every 8 hours for the same period.

All participants will receive standard spinal anesthesia for surgery. Pain will be measured using a simple pain scale at 1, 6, 12, and 24 hours after the operation. If a participant reports significant pain, additional pain medicine will be given.

The results of this study will help doctors choose the most effective and comfortable method of pain relief for women after cesarean section.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 37 - 42 weeks of gestation
  • planned to go for elective cesarean section

排除标准

  • Women already on long-term analgesics
  • known hypersensitivity to any of the study medications
  • known diabetics (chronic or GDM)

研究组 & 干预措施

IM Diclo

Experimental

Intramuscular diclofenac will be given for first 24-hours

干预措施: Diclofenac 75mg (Drug)

Rectal Diclo

Active Comparator

Diclofenac suppository will be given after caesarean section for first 24-hours

干预措施: Diclofenac 50mg (Drug)

结局指标

主要结局

Postoperative pain

时间窗: Pain will be assessed at 1, 6, 12 and 24-hours after cesarean section

Pain will be assessed on visual analog scale by the blinded assessor

次要结局

  • Rescue Analgesia(From cesarean section to 24-hours postoperatively)

研究者

发起方
CMH Multan Institute of Medical Sciences
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Rimsha Irshad

Principal Investigator

CMH Multan Institute of Medical Sciences

研究点 (1)

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