NCT07379762

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 23, 2026

Last Update Submit

January 23, 2026

Conditions

Cesarean Section PainDiclofenacSuppositoryPostoperative Pain

Keywords

cesarean sectionpostoperative painDiclofenac suppositoryDiclofenac intramuscular

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Rescue Analgesia

    From cesarean section to 24-hours postoperatively

Study Arms (2)

IM Diclo

EXPERIMENTAL

Intramuscular diclofenac will be given for first 24-hours

Drug: Diclofenac 75mg

Rectal Diclo

ACTIVE COMPARATOR

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

Drug: Diclofenac 50mg

Interventions

Diclofenac 75mgDRUG

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

Also known as: Diclofenac sodium, Voltarol
IM Diclo
Diclofenac 50mgDRUG

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

Rectal Diclo

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • weeks of gestation
  • planned to go for elective cesarean section

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMH Multan Institute of Medical Sciences

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Nidda Y Assistant Professor, FCPS

    CMH Multan Institute of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 23, 2026

First Posted

January 30, 2026

Study Start

February 1, 2025

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)