| CTRI Number |
CTRI/2025/02/080883 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing the pain-relieving effects of IV Ibuprofen , Paracetamol and their combination in spine surgery |
|
Scientific Title of Study
|
Comparative evaluation of analgesic efficacy of intravenous ibuprofen, paracetamol and their combination in spine surgery |
| 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 NIKHIL |
| Designation |
PG 1st YEAR RESIDENT |
| Affiliation |
School of medical sciences and research, Sharda Hospital |
| Address |
Department of Anesthesiology , school of medical sciences and research , plot no 32,34, knowledge park 3, greater noida Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9149236591 |
| Fax |
|
| Email |
bhraminikhil1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uttam Chandra Verma |
| Designation |
Professor |
| Affiliation |
School of medical sciences and research |
| Address |
Department of Anesthesiology , school of medical sciences and research , plot no 32,34, knowledge park 3, greater noida Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9968604211 |
| Fax |
|
| Email |
uttam.verma@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uttam Chandra Verma |
| Designation |
Professor |
| Affiliation |
School of medical sciences and research |
| Address |
Department of Anesthesiology , school of medical sciences and research , plot no 32,34, knowledge park 3, greater noida Gautam Buddha Nagar UTTAR PRADESH
UTTAR PRADESH
201310
India |
| Phone |
9968604211 |
| Fax |
|
| Email |
uttam.verma@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
| School of medical sciences and research, plot no 32,34, knowledge park 3, greater noida, Uttar Pradesh, 201310 |
|
|
Primary Sponsor
|
| Name |
School of medical sciences and research |
| Address |
plot no 32, 34 knowledge park 3, greater noida |
| Type of Sponsor |
Private 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 Nikhil Sharma |
School of Medical Sciences and Research ,sharda university |
Department of Anesthesiology ,
second floor , B block , plot no 32,34, knowledge park 3 , Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
9149236591
bhraminikhil1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, School of Medical Sciences and Research, Sharda University, Greater Noida |
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 |
Intravenous Ibuprofen |
Patient will receive intravenous ibuprofen 400 mg (100 ml)8hrly in one IV line and 100 ml NS 8 hourly from another line |
| Intervention |
Intravenous Paracetamol |
Patient will receive IV Paracetamol 1gm (100 ml) 8 hourly in one IV line and 100 ml NS 8 hourly from another line |
| Comparator Agent |
IV IBUPROFEN and IV PARACETAMOL |
Patient will receive IV Ibuprofen 400 mg (100ml ) 8 hourly in one IV line and IV Paracetamol 1gm (100 ml) 8 hourly from another IV line |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade 1-3
2. Age 18-60 years of both gender.
3. Patient scheduled for spine surgery. |
|
| ExclusionCriteria |
| Details |
1. Patient with cardiac and pulmonary disease.
2. Patient with complicated diabetes and hypertension
3. Patient with deranged renal function test and liver function tests.
4. Patients sensitive to propofol, fentanyl, paracetamol, vecuronium, ibuprofen and morphine.
5. Difficulty in the usage of PCA. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the analgesic efficacy of intravenous Ibuprofen and Paracetamol combination on postoperative pain by visual analogue scale. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate and compare the analgesic efficacy of intravenous Ibuprofen and Paracetamol on postoperative pain by visual analogue scale.
2. Postoperative morphine consumption and its side effects.
3. Intraoperative fentanyl consumption in first 4 hrs.
4. Haemodynamic monitoring. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2025 |
| 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
|
Postoperative pain management in spine surgery remains a challenge, with opioids being the primary treatment but associated with significant side effects. Non-opioid alternatives like IV ibuprofen and paracetamol have shown promise in reducing pain and opioid consumption. However, limited research exists on their combined effectiveness.This study aims to compare the analgesic efficacy of IV ibuprofen, IV paracetamol, and their combination in spine surgery patients. The goal is to determine whether a combined approach provides superior pain relief, reduces opioid use, and improves patient outcomes. |