| CTRI Number |
CTRI/2025/04/084571 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
10/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the pain relieving action of Ibuprofen vs Paracetamol in patients undergoing abdominal hysterectomy after the surgery |
|
Scientific Title of Study
|
To Compare the Efficacy of Intravenous Ibuprofen Vs Intravenous Paracetamol as Post Operative Analgesia in Patients Undergoing Abdominal Hysterectomy |
| 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 Sangeetha Arunachalam |
| Designation |
Junior Resident |
| Affiliation |
Dr. DY Patil Medical College, Hospital and Research Centre, Pimpri, Pune |
| Address |
Department of Anaesthesiology,
5th floor, Hi-tech building,
Dr. DY Patil Medical College, Hopital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9538096287 |
| Fax |
|
| Email |
asangeetha998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandip baheti |
| Designation |
Associate Professor |
| Affiliation |
Dr. DY Patil Medical College, Hospital and Research Centre, Pimpri, Pune |
| Address |
Department of Anaesthesiology,
5th floor, Hi-tech building,
Dr. DY Patil Medical College, Hopital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822014401 |
| Fax |
|
| Email |
snbacademics12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandip baheti |
| Designation |
Associate Professor |
| Affiliation |
Dr. DY Patil Medical College, Hospital and Research Centre, Pimpri, Pune |
| Address |
Department of Anaesthesiology,
5th floor, Hi-tech building,
Dr. DY Patil Medical College, Hopital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822014401 |
| Fax |
|
| Email |
snbacademics12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Pharmacy, Hi-tech building, 5th floor, Dr. D.Y.Patil Medical College, hospital and Research Centre, Pimpri, Pune
Maharashtra
India
Pin code: 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Sangeetha Arunachalam |
| Address |
Dr. DY Patil Medical College, Hospital and Research Centre, Pune, Maharashtra
Pin Code- 411018
India
|
| Type of Sponsor |
Other [The study will be sponsored by the primary investigator I.e. Dr. Sangeetha Arunachalam (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 Sangeetha Arunachalam |
Dr. D.Y.Patil Hospital, Pimpri, Pune, Maharashtra - 411018 |
Department of Anaesthesiology,
Hi-tech building, 5th floor,
Dr. D.Y.Patil Medical College, Hospital and Research Centre, Pimpri, Pune
Maharashtra
Pin Code: 411018
Pune
MAHARASHTRA |
9538096287
asangeetha998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Ibuprofen |
Injection Ibuprofen 400 mg administered intravenously post operatively in patients who have undergone abdominal hysterectomy |
| Comparator Agent |
Injection Paracetamol |
Injection Paracetamol 1g administered intravenously post operatively in patients who have undergone abdominal hysterectomy |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA grade 1 or 2 fit patients.
2. Patients undergoing abdominal hysterectomy.
3. Haemodynamically stable patients with all investigations within normal limits.
4. Written informed consents from concerned patients. |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to participate in study
2. Patients with ASA grade 3 and above
3. Patients aged less than 30 and more than 60 years.
4. Patients posted for emergency procedures.
5. Patients with known allergy to the study drugs.
6. Patients with difficult intubation.
7. Patients with psychiatric conditions, coagulopathies, naurological, neuromuscular or cardiovascular disease or impairment of hepatic or renal function.
8. Patients with coagulopathies and contraindications to spinal anaesthesia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic effect of Intravenous Ibuprofen versus Intravenous Paracetamol as post operative analgesia in patients who have undergone abdominal hysterectomy. |
After administration of intravenous analgesic, comparison between 2 groups of efficacy and duration of action by monitoring VAS scores at 0,2,4,6,8,12,24,48 hours respectively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic effect of Intravenous Ibuprofen versus Intravenous Paracetamol as post operative analgesia in patients who have undergone abdominal hysterectomy. |
At baseline, 2 hrs, 4 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs & 48 hrs after administration of medication |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/05/2025 |
| 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="6"
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
|
It is a prospective, randomized, double blinded comparative study to compare the analgesic efficacy of Intravenous Ibuprofen versus Intravenous Paracetamol as post operative analgesics in patients who have undergone abdominal hysterectomy.
Parameters that will be compared between the two groups will be the efficacy, duration of analgesia and time to rescue analgesia between the two groups. |