| CTRI Number |
CTRI/2025/11/097861 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A Comparison of Fentanyl and Diclofenac Skin Patches for Pain Relief After Abdominal Surgery |
|
Scientific Title of Study
|
Comparative Evaluation Of Fentanyl Transdermal Patch With Diclofenac Transdermal Patch For Post Operative Pain Relief In Patients Undergoing Laprotomy Surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Atul Rajput |
| Designation |
Post Graduate Resident |
| Affiliation |
Vardhaman Mahavir Medical College And Safdurjung Hospital |
| Address |
Department of Anaesthesia and Intensive care, VMMC and Safdarjung Hospital, Ansari
Nagar East, New Delhi
New Delhi
South
DELHI
110053
India |
| Phone |
9560158253 |
| Fax |
|
| Email |
atulraj.atulrajput@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhu Bala |
| Designation |
Proffesor |
| Affiliation |
Vardhaman Mahavir Medical College And Safdurjung Hospital |
| Address |
Department of Anaesthesia and Intensive care, VMMC and Safdarjung Hospital, Ansari
Nagar East, New Delhi
New Delhi
South
DELHI
110029
India |
| Phone |
9818997757 |
| Fax |
|
| Email |
madhubsayal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhu Bala |
| Designation |
Proffesor |
| Affiliation |
Vardhaman Mahavir Medical College And Safdurjung Hospital |
| Address |
Department of Anaesthesia and Intensive care, VMMC and Safdarjung Hospital, Ansari
Nagar East, New Delhi
New Delh
South
DELHI
110029
India |
| Phone |
9818997757 |
| Fax |
|
| Email |
madhubsayal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhaman Mahavir Medical College And Safdurjung Hospital New Delhi -110029 |
|
|
Primary Sponsor
|
| Name |
Dr Atul Rajput |
| Address |
B-157/4 Street No.10 New usmanpur Delhi -110053 |
| Type of Sponsor |
Other [Self] |
|
|
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 Atul Rajput |
Vardhaman Mahavir Medical College And Safdurjung Hospital |
Department of Anaesthesia and Intensive care, VMMC and Safdarjung Hospital, Ansari
Nagar East, New Delhi
New Delhi
South
DELHI |
9560158253
atulraj.atulrajput@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: C540||Malignant neoplasm of isthmus uteri, (2) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
TRANSDERMAL DICLOFENAC PATCH |
All patients satisfying inclusion criteria will undergo detailed pre-anesthetic evaluation including history, complete physical examination, and necessary investigations. After explaining the nature of the study, a written informed consent will be obtained from all patients willing to participate in the study. Patients will be randomly allocated to one of study groups using computer generated randomization table. After recording baseline vitals of patient like heart rate, respiratory rate (RR), blood pressure and pulse oximetry (Spo2) ,Group D will receive transdermal diclofenac patch (100mg) 1hr before surgery. Transdermal patches to be applied on clean hairless skin (upper arm or flank area) and to be pressed firmly for 30 sec after application. Patients to be monitored for any skin irritation, rash, itching, application site reaction etc. |
| Intervention |
TRANSDERMAL FENTANYL PATCH |
All patients satisfying inclusion criteria will undergo detailed pre-anesthetic evaluation including history, complete physical examination, and necessary investigations. After explaining the nature of the study, a written informed consent will be obtained from all patients willing to participate in the study. Patients will be randomly allocated to one of study groups using computer generated randomization table. After recording baseline vitals of patient like heart rate, respiratory rate (RR), blood pressure and pulse oximetry (Spo2), Group F will receive transdermal Fentanyl patch (25mcg/h) 12 hrs before surgery Transdermal patches to be applied on clean hairless skin (upper arm or flank area) and to be pressed firmly for 30 sec after application. Patients to be monitored for any skin irritation, rash, itching, application site reaction etc. For fentanyl patches any episodes of respiratory depression and hypoxia by pulse oximetry will be monitored overnight. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 65 yrs
ASA Grade I & II
Undergoing laparotomy surgeries
|
|
| ExclusionCriteria |
| Details |
known allergy to study drugs
patients with local skin conditions preventing patch application
Known opioid dependents and chronic opioid use
pregnant and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Degree of postoperative pain relief by using transdermal fentanyl with transdermal diclofenac patch measured by Visual analog scale (VAS) score. |
Visual analogue scale (VAS) for pain will be assessed post operatively at 1 hr, 2 hr, 4 hr, 8 hr, 24 hr and 48 hrs after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time for first rescue analgesia
Total dose of rescue analgesia in first 24 hours
To assess the Ramsay sedation score (RSS) |
Time of first request for rescue analgesia and number of doses required during first 24 hours and 48 hours will be noted.
Ramsay sedation scoring will be assessed at 1hr, 2 hr., 4 hr., 8hr and 24 hr. and 48 hrs. after surgery. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 3 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study is designed to compare transdermal fentanyl with transdermal diclofenac patch for post operative pain relief in laparotomy surgeries. The patients undergoing laparotomy surgeries under General anaesthesia will be randomly given one of two patches (Trandermal diclofenac or trandermal fentanyl patch) . Pain scores, the amount of additional pain medicine needed in 48 hrs after surgery will be recorded and compared between the two groups. |