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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Cesarean Section Pain; Diclofenac; Suppository
• Intervention / Treatment: Drug: Diclofenac 75mg; Drug: Diclofenac 50mg

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Multan, Punjab Province, Pakistan, 60000
      • CMH Multan Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IM Diclo; Intramuscular diclofenac will be given for first 24-hours	Drug: Diclofenac 75mg; Participants will be given intramuscular diclofenac 75mg 8hourly for first 24-hours after cesarean section; Other Names: Voltarol; Diclofenac sodium
Active Comparator: Rectal Diclo; Diclofenac suppository will be given after caesarean section for first 24-hours	Drug: Diclofenac 50mg; Participants will be given diclofenac suppository every 8 hours for first 24-hours after cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Pain will be assessed on visual analog scale by the blinded assessor	Pain will be assessed at 1, 6, 12 and 24-hours after cesarean section

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescue Analgesia	In cases of VAS > 4, extra analgesia (rescue analgesia) will be given to control pain	From cesarean section to 24-hours postoperatively

Collaborators and Investigators

• Sponsor: CMH Multan Institute of Medical Sciences
• Investigators: Study Chair: Nidda Y Assistant Professor, FCPS, CMH Multan Institute of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: cesarean section; postoperative pain; Diclofenac suppository; Diclofenac intramuscular
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Phenylacetates; Diclofenac
• Other Study ID Numbers: U1111-1334-5132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No