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CTRI Number  CTRI/2017/01/007714 [Registered on: 16/01/2017] Trial Registered Retrospectively
Last Modified On: 12/01/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational study 
Study Design  Other 
Public Title of Study   A study on Chronic pain in children undergoing inguinal hernia repair 
Scientific Title of Study   An Observational study on Chronic Post Surgical Pain in children undergoing unilateral inguinal hernia surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepika Nagar 
Designation  Post graduate junior resident 
Affiliation  Lady Hardinge Medical College and Associated hospitals 
Address  Room No. 208, RMO-A, Lady Hardinge Medical College, New Delhi

New Delhi
DELHI
110001
India 
Phone  9711674404  
Fax    
Email  deepika151088@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ajai Kumar 
Designation  Director professor 
Affiliation  Lady Hardinge Medical College and Associated hospitals 
Address  Department of Anaesthesiology, Lady Hardinge Medical College, New Delhi, 110001
Department of Anaesthesiology, Lady Hardinge medical college & associated hospitals, New Delhi, 110001
New Delhi
DELHI
110001
India 
Phone  9899589275  
Fax    
Email  drajaikumar11@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deepika Nagar 
Designation  Post graduate junior resident 
Affiliation  Lady Hardinge Medical College and Associated hospitals 
Address  Room No. 208, RMO-A, Lady Hardinge Medical College, New Delhi

New Delhi
DELHI
110001
India 
Phone  9711674404  
Fax    
Email  deepika151088@gmail.com  
 
Source of Monetary or Material Support  
Lady Hardinge Medical College and Associated hospitals,shaheed bhagat singh marg, New Delhi-110001 
 
Primary Sponsor  
Name  Lady hardinge medical college and associated hospitals 
Address  Lady Hardinge Medical College and associated hospitals, Shahid Bhagat Singh Marg, New Delhi 
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 Deepika Nagar  Kalawati saran childrens hospital  KSCH Operation Theater, Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Marg, New Delhi
New Delhi
DELHI 
9711674404

deepika151088@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for human research, Lady Hardinge Medical College and associated hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Children aged 2-8 years undergoing unilateral inguinal hernia surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  ASA grade I & II children aged 2-8 years undergoing unilateral inguinal hernia surgeries under general anaesthesia 
 
ExclusionCriteria 
Details  • Refusal by the parents of the patient.
• Patients having allergy to any drug.
• Patients with previous surgery at same site.
• Patients with any major systemic disease.
• Surgery lasting more than 90 minutes.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of chronic post surgical pain in children aged 2-8 years at 3 months after undergoing unilateral inguinal surgery  3 months postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of acute postoperative pain in children aged 2-8 years undergoing unilateral inguinal hernia surgery  24 hours postoperatively 
Severity and character of chronic postsurgical pain in children aged 2-8years undergoing unilateral inguinal hernia surgery  3 months postoperatively
 
Factors affecting chronic postsurgical pain  Till 3 months postoperatively 
 
Target Sample Size   Total Sample Size="113"
Sample Size from India="113" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is an observational prospective study on chronic postsurgical pain in children undergoing unilateral inguinal hernia surgery. ASA grade I & II children aged 2-8 years undergoing unilateral inguinal hernia surgeries under general anaesthesia were included in the study population. After pre anaesthetic checkup written informed consent was taken from parents/guardian of the patients.  Anaesthesia was administered the institutional protocols including oral midazolam (0.5mg/kg) administered 30 minutes prior to surgery & surgery was conducted under GA with any of the three blocks (Caudal, INB, PVB) as per the choice of the consultant anaesthesiologist. Patients were shifted to the recovery room after surgery and acute post operative pain was assessed by observation of FLACC (Face, Legs, Activity, Cry, Consolability) Score at 0, 2, 4, 6, 12 and 24 hours. They were followed up at three months following surgery for assessment of chronic postsurgical pain using revised Bieri’s faces pain scale. Various factors were studied for any association with chronic postsurgical pain including - age, gender, duration of surgery, surgeon’s experience, anaesthetic technique used, and acute postoperative pain.

 
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