| CTRI Number |
CTRI/2025/10/095897 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Intravenous Ibuprofen versus Intravenous Paracetamol for Postoperative Pain Management in Vaginal Hysterectomy Patients Under Spinal Anaesthesia. |
|
Scientific Title of Study
|
A prospective randomized study to compare Intravenous Ibuprofen versus Intravenous Paracetamol in post operative pain management of vaginal hysterectomy patients under spinal 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. Pooja Zala |
| Designation |
Resident Doctor (MD Anesthesiology) |
| Affiliation |
GMERS Medical college and Hospital, Gotri, Vadodara |
| Address |
6th floor, Department of Anesthesia, GMERS Medical College and Hospital, Gotri, Vadodara
Vadodara
GUJARAT
390021
India |
| Phone |
7990296116 |
| Fax |
|
| Email |
poojazala999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anup Chandnani |
| Designation |
Professor and Medical Superintendent |
| Affiliation |
GMERS Medical college and Hospital, Gotri, Vadodara |
| Address |
6th floor , Department of Anesthesiology, GMERS Medical College and Hospital, Gotri, Vadodara
Vadodara
GUJARAT
390021
India |
| Phone |
9925436505 |
| Fax |
|
| Email |
anupchandnani29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Pooja Zala |
| Designation |
Resident Doctor (MD Anesthesiology) |
| Affiliation |
GMERS Medical college and Hospital, Gotri, Vadodara |
| Address |
6th floor, Department of Anesthesiology, GMERS Medical College and Hospital, Gotri, Vadodara
Vadodara
GUJARAT
390021
India |
| Phone |
7990296116 |
| Fax |
|
| Email |
poojazala999@gmail.com |
|
|
Source of Monetary or Material Support
|
| GMERS Medical College and Hospital, Gotri, Vadodara , Gujarat, India - 390021 |
|
|
Primary Sponsor
|
| Name |
GMERS Medical College and Hospital Gotri Vadodara |
| Address |
GMERS Medical College and Hospital Gotri,Old TB Hospital, Gotri Main Road,Gotri, Vadodara , Gujarat, India- 390021 |
| Type of Sponsor |
Government 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 Pooja Zala |
GMERS Medical College and Hospital Gotri |
6th floor Department of Anesthesiology, GMERS Medical College and Hospital, Gotri, Vadodara
Vadodara
GUJARAT |
7990296116
poojazala999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
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 |
IV Ibuprofen |
SAB given using Inj Bupivacaine (0.5%) 3.6 ml + Inj Butorphanol 0.2 mg (0.2 ml) to make a total volume of 3.8 ml injected into subarachnoid space using 23G Quincke’s spinal needle
Immediately post operatively a baseline VAS observed
Study drug that is IV Ibuprofen 800 mg administered 30 mins after shifting the patient to a recovery room and thereafter every 8 hourly till 24 hrs
VAS Score assessed at 30 min, 60 min, 90 min, 2 hours and there after every 2 hours following the 1st dose till 24 hours
Rescue analgesia in the form of Inj Tramadol 2 mg/kg is given if VAS score greater than 4 |
| Comparator Agent |
IV Paracetamol |
SAB given using Inj Bupivacaine (0.5%) 3.6 ml + Inj Butorphanol 0.2 mg (0.2 ml) to make a total volume of 3.8 ml injected into subarachnoid space using 23G Quincke’s spinal needle
Immediately post operatively a baseline VAS observed
Study drug that is IV Paracetamol 1 gm administered 30 mins after shifting the patient to a recovery room and thereafter every 8 hourly till 24 hrs
VAS Score assessed at 30 min, 60 min, 90 min, 2 hours and there after every 2 hours following the 1st dose till 24 hours
Rescue analgesia in the form of Inj Tramadol 2 mg/kg is given if VAS score greater than 4 |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Female patient posted for Vaginal hysterectomy under Spinal anesthesia consenting for participating in this study
Patient aged between 35-65 years
All elective surgeries of ASA I and II patients |
|
| ExclusionCriteria |
| Details |
1.Patient’s refusal
2.History of allergy or hypersensitivity to NSAIDs
3.History of Peptic ulcer or intestinal Inflammatory disease.
4.Contraindications for spinal anaesthesia
5.Coagulation disorders
6.Any systemic organ involvement or any other co morbidity.
7.Duration of Surgery more than 2 hours |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total opioid consumption in 24 hours with use of two study drugs |
Total opioid consumption in 24 hours with use of two study drugs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Compare the duration of analgesia with either of the study drug (from first administration to requirement of rescue analgesia)
To assess hemodynamic stability of both drugs
To compare incidence of adverse events |
Immediate postoperatively, a baseline VAS observed
Study drug administered 30 mins after shifting the patient to a recovery room
VAS Score assessed at 30 min,60 min, 90min, 2hrs & there after every 2 hrs following the 1st dose till 24 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
19/11/2025 |
| 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="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
|
This prospective randomized controlled study is designed to compare the efficacy and safety of intravenous ibuprofen versus intravenous paracetamol in the management of postoperative pain in patients undergoing vaginal hysterectomy under spinal anesthesia.
Eligible patients will be randomized into two groups:
Group I (Ibuprofen group): will receive IV ibuprofen 800 mg every 8 hours.
Group P (Paracetamol group): will receive IV paracetamol 1 g every 8 hours.
•SAB using Inj Bupivacaine heavy (0.5%) 3.6 ml + Inj Butorphanol 0.2 mg , to make total volume of 3.8 ml injected into subarachnoid space using 23 Q Quincke’s spinal needle •Immediately post operatively, a baseline VAS observed. •Study drug administered 30 mins after shifting the patient to a recovery room. • VAS Score assessed at 30 min, 60 min, 90 min, 2 hours and there after every 2 hours following the first dose till 24 hours. • Rescue analgesia in the form of Inj Tramadol 2 mg/kg is given if VAS score more than 4 •T0 is the time of giving the first dose of study drug and the time from T0 to first rescue analgesia will be considered as the total duration of analgesia.
The primary outcome is to compare the total opioid consumption in 24 hours with the use of two study drugs.
The secondary outcomes such as to compare the duration of analgesia with either of the study drug (from first administration to requirement of rescue analgesia), assess hemodynamic stability of both drugs and to compare the incidence of adverse events
This study aims to evaluate and compare the analgesic efficacy, duration of pain relief, opioid sparing effect of IV ibuprofen (new formulation) and IV paracetamol in the clinical setting. |