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CTRI Number  CTRI/2020/08/026972 [Registered on: 04/08/2020] Trial Registered Prospectively
Last Modified On: 03/11/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Measurement of pain severity and its relation with the different pain relieving methods in patients undergoing spinal instrumentation surgery 
Scientific Title of Study   Assessment of pain intensity and the association of patient satisfaction with analgesic therapy in patients undergoing spinal instrumentation surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rudrashish Haldar 
Designation  Assistant Professor 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences 
Address  Dept. of Anaesthesiology, First Floor , A Block,Sanjay Gandhi Post Graduate Institute of Medical Sciences, Rae Bareli Road, Lucknow
Rae Bareli Road, Lucknow,Uttar Pradesh
Lucknow
UTTAR PRADESH
226014
India 
Phone  9256543256  
Fax    
Email  rudrashish@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Rudrashish Haldar 
Designation  Assistant Professor 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences 
Address  Dept. of Anaesthesiology, First Floor , A Block,Sanjay Gandhi Post Graduate Institute of Medical Sciences, Rae Bareli Road, Lucknow
Rae Bareli Road, Lucknow,Uttar Pradesh

UTTAR PRADESH
226014
India 
Phone  9256543256  
Fax    
Email  rudrashish@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Rudrashish Haldar 
Designation  Assistant Professor 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences 
Address  Dept. of Anaesthesiology, First Floor , A Block,Sanjay Gandhi Post Graduate Institute of Medical Sciences, Rae Bareli Road, Lucknow
Rae Bareli Road, Lucknow,Uttar Pradesh

UTTAR PRADESH
226014
India 
Phone  9256543256  
Fax    
Email  rudrashish@yahoo.com  
 
Source of Monetary or Material Support  
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Rae Bareli Road,Lucknow,Uttar Pradesh,226014 
 
Primary Sponsor  
Name  Sanjay Gandhi Post Graduate Institute of Medical Sciences 
Address  Rae Bareli Road, Lucknow,Uttar Pradesh 
Type of Sponsor  Research institution and hospital 
 
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 Rudrashish Haldar  Sanjay Gandhi Post Graduate Institute of Medical Sciences  Dept. of Anaesthesiology,First Floor, A Block, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Rae Bareli Road, Lucknow
Lucknow
UTTAR PRADESH 
9256543256

rudrashish@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients (18-65 years)
Patients of either gender
ASA I and II patients
Single or two levels spinal instability requiring fusion
 
 
ExclusionCriteria 
Details  Patients who are unable to communicate in Hindi

Patients suffering from chronic pain

Patients receiving antipsychotic drugs

Patients consuming analgesics on regular basis

Patients undergoing surgery for malignant disorders and trauma
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the prevalence and the perceived intensity of pain in the immediate post operative period (PACU), on the second and the third post operative day in patients undergoing spinal instrumentation surgery  6 hours after arrival in Post Anaesthesia Care Unit, 2nd post operative day and 3rd post operative day 
 
Secondary Outcome  
Outcome  TimePoints 
1) To determine the correlation between the intensity of pain experienced by the patients and their satisfaction with the pain control measures undertaken by the caregivers  6 hours after arrival in Post Anaesthesia Care Unit, 2nd post operative day and 3rd post operative day 
 
Target Sample Size   Total Sample Size="65"
Sample Size from India="65" 
Final Enrollment numbers achieved (Total)= "65"
Final Enrollment numbers achieved (India)="65" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/08/2020 
Date of Study Completion (India) 27/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  
Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Spinal instrumentation surgeries are intensely painful procedures. Incongruence exists regarding severity of pain following spinal surgeries and the level of satisfaction of patients with respect to their pain control measures. We attempt to assess the intensity of the pain perceived by patients in the post operative period and dereive whether any correlation exist between the severity of pain perceived and the levels of satisfaction to their pain control measures 
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