Cesarean Section PainPhase 4NCT07379762
Intramuscular Versus Rectal Diclofenac for Pain Relief After Cesarean Section in Women
A Phase 4 study testing Diclofenac 75mg and Diclofenac 50mg in people with Cesarean Section Pain and Diclofenac, run by CMH Multan Institute of Medical Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Cesarean Section Pain, Diclofenac, Suppository
- What is being tested?
- Diclofenac 75mg and Diclofenac 50mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2025to 31 Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 37 - 42 weeks of gestation
- planned to go for elective cesarean section
Who cannot join
- Women already on long-term analgesics
- known hypersensitivity to any of the study medications
- known diabetics (chronic or GDM)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
CMH Multan Institute of Medical Sciences
Multan, Punjab Province, 60000
About this study
Official title: 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.
Read more
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.
- Conditions
- Cesarean Section Pain, Diclofenac, Suppository, Postoperative Pain
- Being tested
- Diclofenac 75mg, Diclofenac 50mg
- Keywords
- cesarean section, postoperative pain, Diclofenac suppository, Diclofenac intramuscular
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac 75mgDrug
Also called Diclofenac sodium, Voltarol
Participants will be given intramuscular diclofenac 75mg 8hourly for first 24-hours after cesarean section
Diclofenac 50mgDrug
Participants will be given diclofenac suppository every 8 hours for first 24-hours after cesarean section
| Study group | Role | What they receive |
|---|---|---|
| IM Diclo | Experimental | Intramuscular diclofenac will be given for first 24-hours Receives: Drug: Diclofenac 75mg |
| Rectal Diclo | Active comparator | Diclofenac suppository will be given after caesarean section for first 24-hours Receives: Drug: Diclofenac 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Pain will be assessed on visual analog scale by the blinded assessor
Measured: Pain will be assessed at 1, 6, 12 and 24-hours after cesarean section
Secondary outcomes (1)
Rescue Analgesia
In cases of VAS > 4, extra analgesia (rescue analgesia) will be given to control pain
Measured: From cesarean section to 24-hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Feb 2025
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMH Multan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rimsha Irshad, CMH Multan Institute of Medical Sciences
- Investigators
- Nidda Y Assistant Professor, FCPS, Study chair, CMH Multan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379762
- Sponsor's protocol ID
- U1111-1334-5132
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intramuscular Versus Rectal Diclofenac Sodium in Post Caesarean Pain Relief
- ClinicalTrials.gov ID
- NCT07379762
- Acronym / sponsor ID
- U1111-1334-5132
- Conditions
- Cesarean Section Pain, Diclofenac, Suppository, Postoperative Pain
- Keywords
- cesarean section, postoperative pain, Diclofenac suppository, Diclofenac intramuscular
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CMH Multan Institute of Medical SciencesOther government
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IM Diclo | Experimental | Drug: Diclofenac 75mgIntramuscular diclofenac will be given for first 24-hours |
| Rectal Diclo | Active comparator | Drug: Diclofenac 50mgDiclofenac suppository will be given after caesarean section for first 24-hours |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 37 - 42 weeks of gestation
- planned to go for elective cesarean section
Key exclusion criteria (3 listed)
- Women already on long-term analgesics
- known hypersensitivity to any of the study medications
- known diabetics (chronic or GDM)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac 75mgAlso: Diclofenac sodium, VoltarolParticipants will be given intramuscular diclofenac 75mg 8hourly for first 24-hours after cesarean section | Drug | IM Diclo |
| Diclofenac 50mgParticipants will be given diclofenac suppository every 8 hours for first 24-hours after cesarean section | Drug | Rectal Diclo |
Primary outcome
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
1 secondary outcome
Rescue Analgesia
Time frame: From cesarean section to 24-hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Pain
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Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality After Elective Cesarean Section
Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section
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Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
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Lateral QL Block vs Intrathecal Morphine for Cesarean Section
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nidda Y Assistant Professor, FCPS study chair
CMH Multan Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac 75mg and Diclofenac 50mg in people with Cesarean Section Pain and Diclofenac, run by CMH Multan Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: Pain will be assessed at 1, 6, 12 and 24-hours after cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.