| CTRI Number |
CTRI/2022/10/046425 [Registered on: 12/10/2022] Trial Registered Prospectively |
| Last Modified On: |
06/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARATIVE STUDY OF TRANSDERMAL DICLOFENAC PATCH AND INJECTION DICLOFENAC IN PATIENTS WITH INGUINAL HERNIA SURGERY FOR POSTOPERATIVE PAIN RELIEF. |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF TRANSDERMAL DICLOFENAC PATCH VERSUS IM INJECTION DICLOFENAC IN PATIENTS WITH INGUINAL HERNIA SURGERY:POST OPERATIVE PAIN RELIEF. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR BHAVINI SHAH |
| Designation |
PROFESSOR |
| Affiliation |
DR DY PATIL MEDICAL COLLEGE , PIMPRI , PUNE. |
| Address |
DEPARTMENT OF ANEASTHESIOLOGY, DR DY PATIL MEDICAL COLLEGE, PIMPRI, PUNE
DEPARTMENT OF ANEASTHESIOLOGY, DR DY PATIL MEDICAL COLLEGE, PIMPRI, PUNE
Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BHAVINI SHAH |
| Designation |
PROFESSOR |
| Affiliation |
DR DY PATIL MEDICAL COLLEGE , PIMPRI , PUNE. |
| Address |
DEPARTMENT OF ANEASTHESIOLOGY, DR DY PATIL MEDICAL COLLEGE, PIMPRI, PUNE
DEPARTMENT OF ANEASTHESIOLOGY, DR DY PATIL MEDICAL COLLEGE, PIMPRI, PUNE
Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AFREEN SHAMSUDDIN BOAT |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR DY PATIL MEDICAL COLLEGE , PIMPRI , PUNE. |
| Address |
DEPARTMENT OF ANEASTHESIOLOGY, DR DY PATIL MEDICAL COLLEGE, PIMPRI, PUNE
DEPARTMENT OF ANEASTHESIOLOGY, DR DY PATIL MEDICAL COLLEGE, PIMPRI, PUNE
Pune
MAHARASHTRA
411018
India |
| Phone |
8976176796 |
| Fax |
|
| Email |
aaffiisb@gmail.com |
|
|
Source of Monetary or Material Support
|
| dr dy patil medical college and hospital, pimpri , pune. |
|
|
Primary Sponsor
|
| Name |
DR AFREEN SHAMSUDDIN BOAT |
| Address |
dr dy patil medical college, pimpri, pune. 411018. |
| Type of Sponsor |
Other [] |
|
|
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 BHAVINI SHAH |
DR DY PATIL MEDICAL COLLEGE AND HOSPITAL , PIMRI , PUNE |
DEPATMENT OF ANEATHESIOLOGY, DR DY PATIL MEDICAL COLLEGE AND HOSPITAL , PIMRI , PUNE. 411018.
Pune
MAHARASHTRA |
9850829994
drbhavinishah71@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics sub- committee, DR DY PATIL MEDICAL COLLGE, PIMPRI , PUNE. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
diclofenac intramuscular injection 75 mg |
diclofenac intramuscular injection 75 mg in group DI will be injected just after spinal anesthesia on contralateral side. |
| Intervention |
diclofenac patch 100 mg |
diclofenac patch 100 mg in group DP will be applied just after induction of spinal anesthesia in on contralateral side .
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing inguinal hernia correction surgeries who are hemodynamically stable, with all routine investigations within normal limits without any other co morbidities. |
|
| ExclusionCriteria |
| Details |
Patients with ASA physical status III or more.
Patients contraindicated for spinal anesthesia.
Patients with co- morbidities like diabetes, hypertension, neurological, psychiatric or neurovascular disorders.
Patients with drug allergies.
Patient refusal.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS SCORE 0-1 |
12 hours post operative. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS SCORE 1-2 |
at 24 hours post operative. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/11/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
this is a comparitive study of transdermal diclopatch 100 mg and IM diclofenac injection 75 mg in patient undergoing inguinal hernia surgeries for post operative pain relief. |