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CTRI Number  CTRI/2024/05/067317 [Registered on: 14/05/2024] Trial Registered Prospectively
Last Modified On: 14/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the correlation of pre emptive analgesia with ibuprofen with post operative IL-6 levels in patients undergoing elective surgeries under general anaesthesia. 
Scientific Title of Study   Effect of pre-emptive analgesia with ibuprofen on post operative interleukin 6 levels in patients undergoing elective surgical procedure under general anaesthesia. 
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 Simran Raina 
Designation  Post graduate student 
Affiliation  Government medical college and hospital, Sector 32, Chandigarh 
Address  Department of anaesthesia and intensive care, block-D, level-5,GMCH, Sector 32-B Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9877643651  
Fax    
Email  Simranrainaa89@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjeev Palta 
Designation  Professor and head 
Affiliation  Government medical college and hospital,Sector-32,Chandigarh 
Address  Department of anaesthesia and intensive care, block-D, level-5,GMCH, Sector 32-B Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121523  
Fax    
Email  sanjeev_palta@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Richa Saroa 
Designation  Professor 
Affiliation  Government medical college and hospital, Sector-32,  
Address  Department of anaesthesia and intensive care, block-D, level-5,GMCH, Sector 32-B Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121513  
Fax    
Email  richajayant@rediff.com  
 
Source of Monetary or Material Support  
Department of anaesthesia and intensive care,Block-D, level-5,GMCH, Sector-32-B, Chandigarh pin code:160030 
 
Primary Sponsor  
Name  Department of anaesthesia and intensive care GMCH Chandigarh 
Address  Department of anaesthesia and intensive care, block-D, level-5,GMCH, Sector 32-B Chandigarh pin code:160030 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Simran Raina  Government medical college and hospital, Chandigarh  Department of anaesthesia and intensive care, block-D, level-5,GMCH, Sector 32-B Chandigarh
Chandigarh
CHANDIGARH 		 9877643651

Simranrainaa89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, GMCH, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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   administering Iv Ibuprofen 400mg 30 minutes before the surgery in the test group. 
Comparator Agent  Normal saline  Normal saline will be administered intravenously 30 minutes before the surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients undergoing elective surgery of duration less than 120 minutes under general anaesthesia 
 
ExclusionCriteria 
Details  1.Refusal of patients for taking part in the study
2.Patients allergic to ibuprofen
3.Patients with thrombocytopenia
4.Patients with renal impairment
5.Patients with gastric ulcers
6.Patients with severe cardiac, renal and neurological issues.
7.Patients unable to comprehend the post operative pain scores
8.Patients with lateral sinus/ sigmoid sinus/ cavernous sinus thrombosis, petrous apicites, brain abscess

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of pre emptive analgesia with ibuprofen on post operative IL-6 levels in patients undergoing elective surgeries under general anaesthesia.  baseline and at 6 hours after the surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1.To determine IL6 levels in the preoperative and post operative period and draw correlation between them
2.To calculate the time to first analgesic request and total cumulative dose of post operative analgesic over 24 hours
3.To evaluate post operative VAS scores and post operative nausea and vomiting at stipulated time intervals
4.Note any side effect pertaining to the drug administered.
5.To evaluate post operative hemodynamics 		 baseline,30 minutes,60 minutes, 6 hours, 12 hours, 24 hours 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   02/06/2024 
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 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   Pre emptive analgesia with ibuprofen is an evolving clinical concept for post operative pain management.IL6 indicates the extent of tissue damage and is a reliable indicator for post operative pain and inflammation.
Therefore the present study is being conducted to study the effect of pre emptive analgesia with ibuprofen on post operative IL6 levels.
Sample size calculation
The sample size was deduced to be 62. It was decided to enroll 80 patients of either gender within the age group of 18 to 65  according to the inclusion and exclusion crireria.
All the patients will be kept fasting for 8 hours before the surgery. Pre medications will be given as per the standard instituitiional protocol.
In the pre operative area a venous blood sample will be withdrawn to assess the pre operative IL6 levels
30 minutes prior to the surgery the patients will be administered either ibuprofen 400 mg or normal saline intravenously.
The surgery will be conducted as per the requirement.
In the post operative area pain using VAS scores nausea using CSS and heamodynamics will be assessed at 0 mins 30 mins 60 mins 6 hours 12 hours and 24 hours after the surgery.
Cummulative consumption of post operative analgesia using IV PCA pump and the time to first analgesic request will also be assessed.
Post operative sample of venous blood will be withdrawn 6 hours after the surgery for assessing the post operative IL6 levls.
All the observations will be noted in the prescribed performa and pre and post operative levels of IL6 will be correlated to study the effect of pre emptive analgesia with ibuprofen on post operative IL6 levels.
 
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