| CTRI Number |
CTRI/2026/02/104394 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the pain relief by diclofenac given as intravenous or skin patch to patients undergoing middle ear surgery |
|
Scientific Title of Study
|
An observational study to compare the effect of intravenous versus transdermal diclofenac on post operative pain in middle ear surgeries under General Anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi Shadija |
| Designation |
PG Resident |
| Affiliation |
PCMS and RC Bhopal |
| Address |
Room No 1 Dept of Anesthesia 1st floor Peoples Hospital PCMS and RC Bhanpur Bhopal
Peoples college of medical sciences and research centre bhanpur bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9130640288 |
| Fax |
|
| Email |
ruchishadijasatna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahima Batra |
| Designation |
Professor and Head of Department |
| Affiliation |
PCMS and RC Bhopal |
| Address |
Room No 1 Dept of Anesthesia 1st floor Peoples Hospital PCMS and RC Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9752075418 |
| Fax |
|
| Email |
drmahimabatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahima Batra |
| Designation |
Professor and Head of Department |
| Affiliation |
PCMS and RC Bhopal |
| Address |
Room No 1 Dept of Anesthesia 1st floor Peoples Hospital PCMS and RC Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9752075418 |
| Fax |
|
| Email |
drmahimabatra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples Hospital Peoples College of Medical Sciences and Research Centre Bhopal Madhya Pradesh |
|
|
Primary Sponsor
|
| Name |
Peoples Hospital Bhopal |
| Address |
Peoples College of Medical Sciences and Research Centre Bhanpur Bhopal |
| Type of Sponsor |
Private 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 Ruchi Shadija |
Peoples Hospital |
Peoples College Of Medical Sciences and Research Centre Bhanpur Bhopal
Bhopal
MADHYA PRADESH |
9130640288
ruchishadijasatna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee peoples college of medical sciences and researc centre bhanpur bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous diclofenac |
Patients in group I will be given intravenous diclofenac 8 hourly postoperatively |
| Comparator Agent |
Transdermal diclofenac patch |
Patients in group T will be applied transdermal diclofenac patch preoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age between 18-45 years of both female and male gving informed consent |
|
| ExclusionCriteria |
| Details |
1)Patients not giving informed consent
2)Patients with history of hypersensitivity with diclofenac
3)ASA grade more than II
4)History of peptic ulcer disease
5)Known case or history of renal dysfunction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain after middle ear surgery |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic parameters |
48 hours |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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="0"
Months="6"
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
|
Patients posted for middle ear surgery will be divided randomly into 2 groups one group will be given intravenous diclofenac 8 hourly postoperatively and other group will be applied transdermal diclofenac patch preoperatively and pain will be assessed using visual analog scale postoperatively upto 48 hours |