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

CMH Multan Institute of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Diclofenac; Suppository; Cesarean Section Pain

Treatments: Drug: Diclofenac 75mg; Drug: Diclofenac 50mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07379762

U1111-1334-5132

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

IM Diclo

Experimental group

Description:

Intramuscular diclofenac will be given for first 24-hours

Treatment:

Drug: Diclofenac 75mg

Rectal Diclo

Active Comparator group

Description:

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

Treatment:

Drug: Diclofenac 50mg