| CTRI Number |
CTRI/2025/02/080511 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the vas score & Post operative Mointoring of Ketoprofen vs Intravenous Ibuprofen in Lower Segemnt Casearen Section |
|
Scientific Title of Study
|
To compare the Efficacy of Ketoprofen patch vs Intravenous Ibuprofen as Post Operative Analgesia in Lower Segment Casearen Section |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sircilla Ananthkumar |
| Designation |
Junior Resident,Department of Anaesthesiology |
| Affiliation |
Dr.D.Y.Patil Medical College,Hospital and Research Centre |
| Address |
Department of Anaesthesia,5th floor, Dr.D.Y.Patil Medical College,Hospital and Research Centre,Sant Tukaram Nagar,Pimpri-Chinchwad
Pune
MAHARASHTRA
411018
India |
| Phone |
9701489085 |
| Fax |
|
| Email |
ananthsircilla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandip Baheti |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Dr.D.Y.Patil Medical College,Hospital and Research Centre |
| Address |
Department of Anaesthesia,5th floor, Dr.D.Y.Patil Medical College,Hospital and Research Centre,Sant Tukaram Nagar,Pimpri-Chinchwad
Pune
MAHARASHTRA
411018
India |
| Phone |
9822014401 |
| Fax |
|
| Email |
snbacademics12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandip Baheti |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Dr.D.Y.Patil Medical College,Hospital and Research Centre |
| Address |
Department of Anaesthesia,5th floor, Dr.D.Y.Patil Medical College,Hospital and Research Centre,Sant Tukaram Nagar,Pimpri-Chinchwad
Pune
MAHARASHTRA
411018
India |
| Phone |
9822014401 |
| Fax |
|
| Email |
snbacademics12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil Medical College,Hospital and Research Centre,Sant Tukaram Nagar,Pimpri-Chinchwad,Pune,Maharashtra 411018 Pune Maharashtra 411018 India |
|
|
Primary Sponsor
|
| Name |
Sircilla Ananthkumar |
| Address |
Department of Anaesthesia,5th floor, Dr.D.Y.Patil Medical College,Hospital and Research Centre,Sant Tukaram Nagar,Pimpri-Chinchwad,Pune,Maharashtra 411018 India |
| 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 |
| DRSircilla Ananthkumar |
Dr.D.Y.Patil Medical College,Hospital and Research Centre |
Department of Anaesthesia,5th floor,Dr.D.Y.Patil Medical College,Hospital and Research Centre,Sant Tukaram Nagar,Pimpri-Chinchwad,Pune,Maharashtra 411018 India
Pune
MAHARASHTRA |
9701489085
ananthsircilla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics sub-committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Ibuprofen
as Post Operative Analgesia in Lower Segment Caesarean Section |
Patients will be given Injection Ibuprofen 400mg Intravenously with 100 mL of NS At time of Sutures |
| Intervention |
To compare the Efficacy of Ketoprofen patch in Lower Segment Caesarean Section |
Ketoprofen Transdermal Patch 30mg will be applied on left shoulder posteriorly 10
minutes before spinal anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade I or II fit patients.
Patients aged between 21 and 45 years of age.
Patients undergoing Lower Segment Caesarean Section under spinal anaesthesia
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 21 and more than 45 years of age.
Patients with known allergy to the study drugs.
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
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the Efficacy of Ketoprofen patch vs Intravenous Ibuprofen
as Post Operative Analgesia in Lower Segment Caesarean Section |
a.To assess the VAS score and Ramsay sedation score at 2,4,6,8,12,16, 24 and 48
hours post operatively.
b. To observe hemodynamic effects of both drugs.
c. To observe any side effects |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the Efficacy of Ketoprofen patch vs Intravenous Ibuprofen
as Post Operative Analgesia in Lower Segment Caesarean Section |
a. VAS score & Ramsay sedation score at 2,4,6,8,12,16, 24 & 48
hours post operatively. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
22/02/2025 |
| 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="2"
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
|
It is a Prospective, randomized, double blinded study,To compare the Efficacy of Ketoprofen patch vs Intravenous Ibuprofen as
Post Operative Analgesia in Lower Segment Caesarean Section Ketoprofen Transdermal Patch 30mg will be applied on left shoulder posteriorly 10
minutes before spinal anaesthesia patients will be given Injection Ibuprofen 400mg Intravenously with 100 mL of NS
|