| CTRI Number |
CTRI/2026/03/106054 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Diclofenac and Ketoprofen pain patches for relief of pain after C-section delivery. |
|
Scientific Title of Study
|
Comparative study of efficacy of Diclofenac and ketoprofen transdermal patches for postoperative pain relief in post LSCS patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Saxena |
| Designation |
Assistant professor |
| Affiliation |
GMC haldwani |
| Address |
Department of Anaesthesiology, Shuseela Tiwari Hospital, Mukhani, Haldwani, Nanital.
Nainital
UTTARANCHAL
263139
India |
| Phone |
9997456219 |
| Fax |
|
| Email |
rahul.cool.1877@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahul Saxena |
| Designation |
Assistant professor |
| Affiliation |
GMC haldwani |
| Address |
Department of Anaesthesiology, Shuseela Tiwari Hospital, Mukhani, Haldwani, Nanital.
Nainital
UTTARANCHAL
263139
India |
| Phone |
9997456219 |
| Fax |
|
| Email |
rahul.cool.1877@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahul Saxena |
| Designation |
Assistant professor |
| Affiliation |
GMC haldwani |
| Address |
Department of Anaesthesiology, Shuseela Tiwari Hospital, Mukhani, Haldwani, Nanital.
Nainital
UTTARANCHAL
263139
India |
| Phone |
9997456219 |
| Fax |
|
| Email |
rahul.cool.1877@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rahul Saxena |
| Address |
Department of Anaesthesiology, Shuseela Tiwari Hospital, Mukhani, Haldwani, Nanital, 263139. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul Saxena |
Government Medical college and Dr. Susheela Tiwari Hospital |
Department of Anesthesiology, critical care, pain and palliative medicine, 2nd floor, Rampur Road Haldwani
Nainital
UTTARANCHAL |
9997456219
rahul.cool.1877@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O750||Maternal distress during labor anddelivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diclofenac Sodium transdermal patch |
After delivery of the baby, Group D, the Diclofenac Sodium 100 mg transdermal patch, will be applied in the right arm deltoid region for 24 hours post delivery. |
| Comparator Agent |
Ketoprofen transdermal patch |
After delivery of the baby, Group K, the Ketoprofen 30mg transdermal patch, will be applied in the right arm deltoid region for 24 hours post delivery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients scheduled for elective or emergency lower segment cesarean section under subarachnoid blockade.
ASA grade II
|
|
| ExclusionCriteria |
| Details |
1. Duration of surgery beyond 90 minutes having intra-op complications.
2. Failed spinal and inadequate spinal anesthesia.
Previous hypersensitivity to NSAIDs or any other drugs.
3. High-risk pregnancy with any previous cardiac, respiratory, renal, and liver disease or any coagulation disorders.
4.Patient requiring opioid for rescue analgesia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy of diclofenac and ketoprofen transdermal patch for post operative pain relief in post lower segment cesarean section patients |
For the first 24 hours post delivery.
at 0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic parameters (HR, SBP, DBP, MBP, SPO2) intraoperatively & postoperatively. |
Intraoperative hemodynamic parameters will be assessed at baseline, 2 min, 4 min, 6 min, 8 min, 10 min, 12 min, 14 min, 16 min, 18 min, 20 min, & every 10 min afterwards.
Postoperative hemodynamic parameters will be assessed after delivery for the first 24 hours at baseline, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, & 24 hours. |
Any adverse drug reaction between the groups.
|
any complications after delivery and application of patch till 24 hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial aims to compare the efficacy of diclofenac and ketoprofen transdermal patches for postoperative pain management in patients undergoing lower segment cesarean section (LSCS) under spinal anesthesia. Postoperative pain after cesarean delivery can delay maternal recovery, breastfeeding, and early mobilization. Transdermal NSAID patches provide a noninvasive and convenient method of analgesic delivery with controlled drug release and fewer gastrointestinal side effects. A total of 108 patients aged 18–40 years, ASA grade II, scheduled for elective or emergency LSCS under spinal anesthesia will be enrolled and randomly allocated into two groups. Group K will receive a Ketoprofen 30 mg transdermal patch, and Group D will receive a Diclofenac 100 mg transdermal patch. The patch will be applied over the deltoid region immediately after delivery of the baby. Pain intensity will be assessed using the Visual Analogue Scale (VAS). If the VAS score exceeds 4, intravenous paracetamol (10 mg/kg) will be administered as rescue analgesia. Hemodynamic parameters, including heart rate, systolic blood pressure, diastolic blood pressure, mean blood pressure, and oxygen saturation, will also be monitored. Adverse drug reactions, if any, will be recorded. The primary objective of the study is to compare the analgesic efficacy of diclofenac and ketoprofen transdermal patches in post-LSCS patients, while secondary objectives include assessment of hemodynamic changes and adverse drug reactions associated with these patches. The results of this study may help identify a more effective and convenient postoperative analgesic modality for cesarean section patients, improving maternal comfort and recovery. |