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CTRI Number  CTRI/2025/07/090057 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 27/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinic trial to study the analgesic effect of fentanyl as an adjuvant to ropivacaine in paediatric patients undergoing infraumbilical surgeries in general anaesthesia  
Scientific Title of Study   A randomized controlled study for analgesic efficacy of fentanyl as an adjuvant to ropivacaine in caudal epidural block in paediatric patients undergoing infraumbilical surgeries in 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 Bhawna meena  
Designation  Junior resident  
Affiliation  S.M.S medical college and hospital jaipur 
Address  Room no.3 pediatric department of anaesthesia
SMS medical college and hospital jaipur
Jaipur
RAJASTHAN
302004
India 
Phone  09672353364  
Fax    
Email  bhawnajagrawal3410@GMAIL.COM  
 
Details of Contact Person
Scientific Query  
Name  Dr Rama chatterjee 
Designation  senior professor 
Affiliation  S.M.S medical college and hospital jaipur 
Address  Room no.8 pediatric anaesthesia department
SMS medical college and hospital jaipur
Jaipur
RAJASTHAN
302004
India 
Phone  9828622026  
Fax    
Email  chatterjeerama30@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rama chatterjee 
Designation  senior professor 
Affiliation  S.M.S medical college and hospital jaipur 
Address  Room no.8 pediatric anaesthesia department
SMS medical college and hospital Jaipur
Jaipur
RAJASTHAN
302004
India 
Phone  9828622026  
Fax    
Email  chatterjeerama30@gmail.com  
 
Source of Monetary or Material Support  
DR. Bhawna meena Room no. 402 P.G girls hostel department of anaesthesia S.M.S medical college and hospital jaipur contact no. 9672353364 
 
Primary Sponsor  
Name  Dr Bhawna meena 
Address  Room No.3 pediatric department of anaesthesia S.M.S medical college and hospital jaipur. 
Type of Sponsor  Other [self] 
 
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 
DrRama chatterjee  S.M.S medical college and hospital jaipur  Pediatric anaesthesia O.T no. 1,2,3 pediatric ward 1,2
Jaipur
RAJASTHAN 		 09828622026

chatterjeerama30@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee S.M.S medical college and hospital jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: N37||Urethral disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Caudal epidura block   analgesic efficacy of fentanyl as an adjuvant to ropivacaine in Caudal epidural block in pediatric patients undergoing infraumbilical surgeries in general anaesthesia in department of anaesthesia, Total duration of intervention is 24 hours. dose of ropivacain 0.2% 1m/kg dose of fentanil 0.5 micrigm/kg route; caudal epidural 
Intervention  Caudal epidural block  analgesic efficacy of fentanyl as an adjuvant to ropivacaine in Caudal epidural block in pediatric patients undergoing infraumbilical surgeries in general anaesthesia .Total duration of intervention is 24 hours. ropivacain 0.2% 1ml/kg stat dose plus fenatnil 0.5 microgramme/kg stat route caudal epidural 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1. Paediatric Patients undergoing Infraumbilical surgeries in general anaesthesia.
2. Patients with written & informed parental consent/ assent (where able applicable).
3. Weight between 16kg to 25 kg
4. ASA grade I and II.  
 
ExclusionCriteria 
Details  1. Noncooperative patient.
2. Patient should not be part of other study.
3. History of hypersensitivity to study drugs.
4. Patients having bleeding/clotting diseases, local infection, sepsis deformity, pre
existing neurological diseases. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To assess and compare time to first rescue analgesic requirement [duration of
postoperative analgesia ] in both the groups .
2. To assess and compare the severity of pain using CHOPS score and RAMSAY
score in both the group. 		 WITHIN 24 HOURS 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess and compare the changes in hemodynamic
variables(SBP,DBP,MAP,HR,SpO2) in the intraoperative period in both groups within
24 hours.
2.To asses and compare the proportion of cases having side effects in both groups 		 WITHIN 24 HOURS 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   20/07/2025 
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="0"
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   • STUDY PERMISSION: Due permission from the institution ethics committee and research review board will be obtained. • STUDY AREA: The study will be conducted in the Department of paediatric Anaesthesia, JK Lone Hospital attached to S.M.S. Hospital, Jaipur. • STUDY DESIGN: Prospective , Randomized, Double blind, Interventional study. • STUDY PERIOD: After approval of the plan from the research review board till the completion of desired sample size. • SAMPLE SIZE: sample size is calculated at 80% study power and error of 0.05 assuming standard deviation of 312.84 minutes of duration of analgesia in ropivacaine + fentanyl group as found in seed article(1)for minimum detectable mean difference of 240 minutes in duration of analgesia between the groups , 27 patients in each group are required as sample size which is further enhanced to 30 patients in each group as final sample size for present study expecting 10% attrition. • RANDOMIZATION – opaque sealed envelope method. • DOUBLE BLINDING- The anaesthesiologist who would give caudal block would be different from the anaesthesiologist who would record study variables. • STUDY UNIVERSE: Pediatric Patients undergoing infraumbilical surgeries under general anaesthesia. 
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