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CTRI Number  CTRI/2024/06/069194 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 14/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Comparing the analgesic efficiency among paracetamol, ibuprofen and paracetamol-ibuprofen given preoperatively by monitoring vitals intraoperatively and VAS score postoperatively in orthopedic surgeries. 
Scientific Title of Study   Comparison of analgesic efficacy of pre-emptive paracetamol, ibuprofen and paracetamol-ibuprofen in orthopedic surgeries. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhinav Rawat 
Designation  Post graduate student 
Affiliation  Govt Medical College and Hospital 
Address  Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9888980472  
Fax    
Email  rawatabhinav1769@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manpreet Singh 
Designation  Professor 
Affiliation  Government Medical College and Hospital 
Address  Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121503  
Fax    
Email  manpreetdawar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manpreet Singh 
Designation  Professor 
Affiliation  Government Medical College and Hospital 
Address  Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121503  
Fax    
Email  manpreetdawar@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care, Block D, Level 5,Government Medical College and Hospital, sector 32-B, Chandigarh, India, Pincode- 160030 
 
Primary Sponsor  
Name  Government Medical College and Hospital 
Address  Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh, India, Pincode- 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 
Abhinav Rawat  Government Medical College and Hospital   Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh
Chandigarh
CHANDIGARH 
09888980472

rawatabhinav1769@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 
Comparator Agent  Ibuprofen  Injection 400 mg intravenously given preoperatively 15 mins before induction 
Intervention  Paracetamol  Injection 1 gm intravenous given preoperatively 15 mins before induction. 
Comparator Agent  Paracetamol and Ibuprofen  Injection paracetamol 1 gm and injection 400 mg intravenously given preoperatively 15 mins before induction. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Inclusion criteria
1 ASA class I or II
2 Age from 18 to 70 years either sex
3 Measuring 150 to 180 cm height, with body mass index BMI of 18 to 35 kg per m2
4 Patients undergoing elective and emergency orthopaedic surgeries requiring spinal anaesthesia
 
 
ExclusionCriteria 
Details  1 All contraindications to spinal analgesia including bleeding diathesis, infection at the puncture site, spinal deformity, patient on anticoagulants, pre existing neurological deficits in lower extremities, unwillingness to give consent.
2 Surgical duration more than 2 hours
3 Sensory blockade inadequate for surgery.
4 Patients having cardiac rhythm abnormalities.
5 History of alcoholism, drug abuse, and psychiatric disorders.
6 History of allergy to any of the study drugs.
7 Hepatic disease, renal disease, cardiopulmonary disease, hypertension, diabetes, central or peripheral nervous system disorders.
8 Chronic pain patients undergoing treatment with opioid analgesic.
9 Pregnant patients.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Pain will be assessed with Visual Analogue Scale between 0 and 10

 
1 Pain will be assessed with Visual Analogue Scale between o and 10 at every 15 minutes till 2 hours and then after every 2 hours till 6 hours and then after 12th hour and at 24th hour in ward.
2 Time of onset of T10 sensory block and time to peak sensory block will be noted
3 Time of onset of Bromage 3 motor block will be noted.
4 Time of supplemental analgesia administered
 
 
Secondary Outcome  
Outcome  TimePoints 
1 To assess the haemodynamics intraoperatively & postoperatively.
2 To assess the adverse effects.
 
1 Haemodynamics like heart rate mean arterial pressure oxygen saturation spo2 will be recorded every 5 minutes during the intraoperative period. Thereafter the parameters will be observed after every 15 minutes till 2 hours postoperatively & thereafter every 2 hours till 6 hours & then at 12th hour & 24th hour postoperatively in ward.
 
 
 
Target Sample Size   Total Sample Size="109"
Sample Size from India="109" 
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)   30/06/2024 
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 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  

The 109 patients will be randomly divided into three groups:

1.     Group B (n=36) will receive 400 mg of Ibuprofen intra-venously 15 minutes before induction

2.     Group D (n=36) will receive 1 gm of Paracetamol intra-venously 15 minutes before induction.

3.     Group P (n=36) will receive 400 mg of Ibuprofen intra-venously and 1 gm of Paracetamol intra-venously 15 minutes before induction.


Procedure on the day of surgery:

15 minutes before induction , the patients in group B will receive 400 mg of inj  ibuprofen intravenously, the  patients in group D will receive 1 gm of inj  paracetamol intravenously, the  patients in group P will receive 400 mg of inj  ibuprofen  and 1 gm of inj paracetamol intravenously.

The operating room will be prepared and anaesthesia machine will be checked. All emergency drugs and equipment will be placed and checked in the operation theatre preoperatively. Standard monitoring with the continuous electrocardiogram , heart rate , non-invasive blood pressure , oxygen saturation  will be done and will be started before induction of anaesthesia. An 18 gauge intravenous cannula will be inserted in large vein of dorsum of non-dominant hand and intravenous line and normal saline at 10 ml/kg will be started for preloading. The study drugs will be administered as a single dose, i.e. 15 minutes before spinal anaesthesia. Under strict asepsis, lumbar puncture will be performed at L3-L 4 or L4-L5 spinal interspace, in sitting position, through a standard midline approach using a 26-G Quincke spinal needle. Hyperbaric, bupivacaine 0.5% 15 mg will be injected intrathecally.

The haemodynamics like  heart rate , mean arterial pressure , oxygen saturation , will be recorded every 5 minutes during the intraoperative period. Thereafter, the parameters will be observed after every 15 minutes till 2 hours postoperatively and thereafter every 2 hours till 6 hours and then at 12th hour and 24th hour postoperatively in ward.

Pain will be assessed using Visual Analogue Scale. It is linear scale, consisting of 10 cm line anchored at one end by a label such as No pain and other end by Worst pain imaginable. Patient simply marks the line to indicate the pain intensity. Pain intensity will be checked when patient is planned to be shifted to postoperative area. It will be baseline pain intensity and patients will be followed up every 15 minutes for next 2 hours in post operative area. Then after every 2 hours till 6 hours and then at 12th hour and finally at 24th hour in wards. Patients with a VAS score of 3 or more will receive injection Diclofenac sodium 75-mg intramuscularly as rescue analgesia whenever it happens. The study will be over when rescue analgesic is administered or after postoperative 24 hours in the ward. The time from administration of spinal anaesthesia to time of rescue analgesia will be total analgesia duration.

The surgery will be conducted as per procedure and no analgesic will be administered intra-operatively. The patient will be shifted to postoperative room and will be monitored there for next 2 hours and then at 6th hour, 12th hour and 24th hour in the ward for post operative pain.



 
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