| CTRI Number |
CTRI/2024/06/069037 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of ketoprofen patch vs diclofenac patch for post operative analgesia in patients operated for Percutaneous Nephrolithotomy (PCNL) and to assess their effect on serum creatinine. |
|
Scientific Title of Study
|
To Compare the Efficacy Of Diclofenac Patch vs Ketoprofen Patch As Post-operative
Analgesia And Effect On Serum Creatinine In Patients Undergoing Percutaneous Nephrolithotomy (PCNL) |
| 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 Vaibhavi Singh |
| Designation |
Junior resident, Department of Anesthesiology |
| Affiliation |
Dr. D. Y. Patil Medical College, Hospital And Research Centre, Pimpri, Pune |
| Address |
Department Of Anesthesia
Old Building, Ground Floor
Dr. D. Y. Patil Medical College, Hospital And Research Centre
Sant Tukaram Nagar
Pimpri
Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7064168997 |
| Fax |
|
| Email |
baibhavis19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandip Baheti |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
Dr. D. Y. Patil Medical College, Hospital And Research Centre, Pimpri, Pune |
| Address |
Department Of Anesthesia
Old Building, Ground Floor
Dr. D. Y. Patil Medical College, Hospital And Research Centre
Sant Tukaram Nagar
Pimpri
Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9822014401 |
| Fax |
|
| Email |
sandipbaheti1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandip Baheti |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
Dr. D. Y. Patil Medical College, Hospital And Research Centre, Pimpri, Pune |
| Address |
Department Of Anesthesia
Old Building, Ground Floor
Dr. D. Y. Patil Medical College, Hospital And Research Centre
Sant Tukaram Nagar
Pimpri
Pune 411018
MAHARASHTRA
411018
India |
| Phone |
9822014401 |
| Fax |
|
| Email |
sandipbaheti1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Pharmacy, HI Tech Building, Ground Floor, Dr. D.Y. Patil Medical College Hospital And Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India 411018 |
|
|
Primary Sponsor
|
| Name |
Vaibhavi Singh |
| Address |
Department Of Anesthesia, OT Complex, HI Tech Building, 5th Floor Floor, Dr. D.Y. Patil Medical College Hospital And Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India 411018 |
| 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 Vaibhavi Singh |
Dr. D. Y. Patil Medical College, Hospital And Research Centre, Pimpri, Pune |
Dr. D. Y. Patil Medical College, Hospital And Research Centre
Ot Complex, 5th Floor
Sant Tukaram Nagar
Pimpri
Pune 411018
Pune
MAHARASHTRA |
7064168997
baibhavis19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS SUB COMMITTEE DR. D. Y. PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
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 |
Diclofenac |
Diclofenac transdermal Patch 100 MG for 48 hours |
| Comparator Agent |
Ketoprofen |
Ketoprofen transdermal Patch 30 MG for 48 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I or II fit patients.
Patients aged between 18 and 60 years of age.
Patients undergoing surgeries under spinal anesthesia.
Hemodynamically stable patients with all routine investigations within normal limits and
without any comorbidities.
Written informed consent from the concerned patient. |
|
| ExclusionCriteria |
| Details |
Patients who are not willing to participate in the study.
Patients with ASA grade III and above physical status.
Patients who are aged less than 18 and more than 60 years of age.
Patients who are posted for emergency procedures.
Patients with known allergy to the study drugs.
Patients who are obese.
Patients who have psychiatric, coagulopathies, neurological, neuromuscular, or
cardiovascular disease or impairment of hepatic or renal function.
Patients with coagulopathies and contraindication to SA |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the Efficacy of Diclofenac patch vs Ketoprofen patch- As Post-op
Analgesia and effect on serum creatinine in Patients Undergoing PCNL. |
To assess the VAS score at 0,4,8,12,16, 24 and 48 hours Post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the Efficacy of Diclofenac patch vs Ketoprofen patch on serum creatinine in Patients Undergoing PCNL. |
Post operatively after 24 hours serum creatinine will be repeated. |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/06/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/09/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
It is a Prospective, randomized, double blinded study to compare the Efficacy of Diclofenac patch vs Ketoprofen patch- As Post-op
Analgesia and effect on serum creatinine in Patients Undergoing PCNL. Post op monitoring of VAS scoring will be recorded at rest, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours and 48 hours postoperatively.
Post operatively after 24 hours serum creatinine will be repeated |