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Completed

NCT Number: NCT07379762

Intramuscular Versus Rectal Diclofenac for Pain Relief After Cesarean Section in Women

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.

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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

CMH Multan Institute of Medical Sciences

Multan, Punjab Province, 60000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Diclofenac 75mg

Drug

Participants will be given intramuscular diclofenac 75mg 8hourly for first 24-hours after cesarean section

Other names: Diclofenac sodium, Voltarol

Diclofenac 50mg

Drug

Participants will be given diclofenac suppository every 8 hours for first 24-hours after cesarean section

Primary outcomes

  1. Postoperative pain

    Time frame: 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

Secondary outcomes

  1. Rescue Analgesia

    Time frame: From cesarean section to 24-hours postoperatively

    In cases of VAS > 4, extra analgesia (rescue analgesia) will be given to control pain

Sponsors and collaborators

Lead sponsor

CMH Multan Institute of Medical Sciences

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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