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CTRI Number  CTRI/2013/08/003915 [Registered on: 23/08/2013] Trial Registered Retrospectively
Last Modified On: 19/08/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the efficacy of two different types of analgesic techniques for postoperative pain relief after lower Abdominal and pelvic surgeries in paediatric surgical cases 
Scientific Title of Study   To compare the efficacy of two different types of analgesic techniques for postoperative pain relief after lower Abdominal and pelvic surgeries in paediatric surgical cases 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aruna Bharti 
Designation  Assistant Professor 
Affiliation   
Address  Department of Anaesthesiology Sanjay Gandhi Post Graduate Institute of Medical Sciences -Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  05222495262  
Fax  91-522-2668017  
Email  arunabha@sgpgi.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aruna Bharti 
Designation  Assistant Professor 
Affiliation   
Address  Department of Anaesthesiology Sanjay Gandhi Post Graduate Institute of Medical Sciences-Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  05222495262  
Fax  91-522-2668017  
Email  arunabha@sgpgi.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Aruna Bharti 
Designation  Assistant Professor 
Affiliation   
Address  Department of Anaesthesiology Sanjay Gandhi Post Graduate Institute of Medical Sciences -Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  05222495262  
Fax  91-522-2668017  
Email  arunabha@sgpgi.ac.in  
 
Source of Monetary or Material Support  
S.P.G.I.M.S. Lucknow 
 
Primary Sponsor  
Name  SPGIMS Lucknow 
Address  S.P.G.I.M.S. Raibarelliroad Lucknow-226014 Uttar Pradesh (India) 
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 Aruna Bharti  Sanjay Gandhi Post Graduate Institute of Medical Sciences- Lucknow  Paediatric Surgery Ward and Paediatric Surgery Operation Theater(O.T.-4),A-Block Sanjay Gandhi Post Graduate Institute of Medical Sciences- Raebarelliroad Lucknow-226014
Lucknow
UTTAR PRADESH 
05222495262
91-522-2668017
arunabha@sgpgi.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Sanjay Gandhi Post Graduate Institute of Medical Sciences,Lucknow Registered with DCGI with registration number of ECR/16/Inst/UP/2013  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  who are undergoing for lower Abdominal and pelvic surgeries in paediatric surgical cases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  preoperative analgesic suppositories of paracetamol which will be given following induction of general anaesthesia  Group II the children’s will be operated under general anaesthesia and will be anesthetized in a standard fashion along with preoperative analgesic suppositories of paracetamol in the dose of 10mg/kg body weight which will be given following induction of general anaesthesia and intermittent bolus doses of intravenous short acting synthetic opioid (fentanyl 2mcg/kg)for control of pain sign/symptoms as rescue analgesic 
Intervention  preoperative caudal epidural block  Group- I, in which the children’s will be operated under general anaesthesia and will be anesthetized in a standard fashion along with preoperative caudal epidural block with 1.5 mg/kg of 0.25% bupivacaine which will be given following induction of general anaesthesia and intermittent bolus doses of intravenous short acting synthetic opioid (fentanyl 2mcg/kg)for control of pain sign/symptoms as rescue analgesic 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1-unpremedicated,
2-ASA class- I paediatric surgical patients of
either sex
3-age between 5-16 yrs
4-can able to understand and comprehend the visual analogue Wong-Baker Faces Scale scoring system
5-undergoing lower abdominal or pelvic surgery  
 
ExclusionCriteria 
Details  1-more than ASA Grade I
2-Age below 5 years and age above 16 years 3-Contraindication to caudal epidural block 4-inability to comprehend the visual analogue Wong-Baker Faces Scale scoring system with visual analogue number rating scoring system  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
outcome of this study will suggest the most effective method of analgesic technique for providing postoperative pain relief in paediatric surgical cases  1, 2, 24 hrs postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
nausea and vomiting will also be noted.Rescue medication (i/v fentanyl 1 microgram/kg) has to be administered if the VAS pain score exceeded 50 at any time. The times from injection to first unsupported standing after anaesthesia and hospital discharge will also be documented  1, 2, 24 hrs postoperatively 
 
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 3/ Phase 4 
Date of First Enrollment (India)   26/10/2012 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   yet not published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Aim: â€œTo compare the efficacy of two different types of analgesic techniques for postoperative pain relief after lower abdominal and pelvic surgeries in paediatric surgical case

Justification for the study:- Here we are trying to study and comparing the efficacy of two different types of analgesic techniques for postoperative pain relief after lower abdominal and pelvic surgeries in paediatric surgical cases.The expected outcome of this study will suggest the most effective method of analgesic technique for providing postoperative pain relief in paediatric surgical cases

methodology - we intend to enrol 80 unpremedicated, ASA class- I paediatric surgical patients of either sex (age between 5–16years) undergoing lower abdominal or pelvic surgery will be included in this study; they will be divided into two groups of 40 each using a randomization chart. Group- I, in which the children’s will be operated under general anaesthesia and will be anesthetized in a standard fashion along with preoperative caudal epidural block which will be given following induction of general anaesthesia and intermittent bolus doses of intravenous short acting synthetic opioid (fentanyl) for control of pain sign/symptoms as rescue analgesic. While in Group II  the children’s will be operated under general anaesthesia and will be anesthetized in a standard fashion along with preoperative analgesic suppositories of paracetamol which will be given following induction of general anaesthesia and intermittent bolus doses of intravenous short acting synthetic opioid (fentanyl) for control of pain sign/symptoms as rescue analgesic. All the recruited patients were instructed on proper use of the visual analogue sliding scale (vas scale) system [0= no pain, 100=worst pain imaginable] at the time PAC a day before surgery as well as again on arrival in the induction room. All the patients were randomized to receive any one of the above two mentioned techniques to get  post operative pain relief .The time of injection of drug (via caudal epidural and via rectal route in the form of suppository) is to be  noted and surgical incision will be allowed after at least 15 minutes had been elapsed subsequently. The pain relief would be deemed unsuccessful if there is a  persistant increase of more than 30% in heart rate or mean arterial blood pressure values above baseline following surgical incision. These patients will be given intravenous fentanyl 1microgm/kg and will be withdrawn from the study. At the end of the surgery all anaesthetics will be stopped and 100% oxygen will be administered.

VAS pain scores will be elicited upon emergence from anesthesia,and at 1 ,2and 24hrs postoperatively after injection of analgesic drug (via caudal epidural and via rectal route in the form of suppository) by blinded investigator. Other adverse events such as nausea and vomiting will also be noted.

Rescue medication (i/v fentanyl 1 microgram/kg) has to be administered if the VAS pain score exceeded 50 at any time.  Other parameters to be studied are quality of night sleep, adverse effects of analgesics, recovery of bowel and bladder function, economic impact and morbidity related to the two techniques.

 


 
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