Intramuscular Versus Rectal Diclofenac for Pain Relief Af... | NCT07379762

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

NCT07379762

Sponsor

CMH Multan Institute of Medical Sciences

Status

Completed

Last Update Posted

Jan 30, 2026Actual

Enrollment

60Actual

Phase

Phase 4

Conditions

Cesarean Section Pain
Diclofenac
Suppository
Postoperative Pain

Interventions

Diclofenac 75mg
Diclofenac 50mg

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2025Actual

Primary Completion Date

Jul 31, 2025Actual

Completion Date

Jul 31, 2025Actual

First Submitted Date

Jan 23, 2026

First Submission Date that Met QC Criteria

Jan 23, 2026

First Posted Date

Jan 30, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2026

Last Update Posted Date

Jan 30, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rimsha Irshad, Principal Investigator, CMH Multan Institute of Medical SciencesPrincipal Investigator

Lead Sponsor

CMH Multan Institute of Medical SciencesOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Diclofenac 75mg	Drug	Participants will be given intramuscular diclofenac 75mg 8hourly for first 24-hours after cesarean section	IM Diclo

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nidda Y Assistant Professor, FCPS	CMH Multan Institute of Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CMH Multan Institute of Medical Sciences		Multan	Punjab Province	60000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004008	Diclofenac

Ancestor Terms

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided