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CTRI Number  CTRI/2025/05/086263 [Registered on: 05/05/2025] Trial Registered Prospectively
Last Modified On: 02/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Finding the Best Dose of a Sedative i.e. Dexmedetomidine Added to a Numbing Medicine i.e. Ropivacaine for Pain Relief in Children After Surgery by caudal block technique: A Controlled Study 
Scientific Title of Study   Optimal dose of Dexmedetomidine added to 0.2 percent Ropivacaine in Caudal Block for post operative analgesia in paediatric patients: a randomised prospective controlled study 
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 Naresh Kumar Murmu 
Designation  Junior Resident 
Affiliation  RAJENDRA INSTITUTE OF MEDICAL SCIENCES 
Address  Department of Anesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand Rajendra Institute Of Medical Sciences

Ranchi
JHARKHAND
834009
India 
Phone  9905832269  
Fax    
Email  nkumar1416@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mukesh Kumar 
Designation  Associate Professor 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of Anesthesiology, RIMS, Bariatu

Ranchi
JHARKHAND
834009
India 
Phone  8709135297  
Fax    
Email  drkmukesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramesh Kumar Kharwar 
Designation  Assistant Professor 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of Anesthesiology, RIMS, Bariatu

Ranchi
JHARKHAND
834009
India 
Phone  8294044274  
Fax    
Email  rameshrims02@yahoo.in  
 
Source of Monetary or Material Support  
Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, India. Pin code 834009 
 
Primary Sponsor  
Name  Rajendra Institute of Medical Sciences 
Address  Department of Anesthesiology, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand 
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 
Dr Naresh Kumar Murmu  Rajendra Institute of Medical Sciences  Department of Anesthesiology RIMS, Bariatu, 834009
Ranchi
JHARKHAND 		 9905832269

nkumar1416@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RIMS, Ranchi  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 
Intervention  Caudal Block  Caudal block given in pediatric patient undergoing lower abdominal and perineal surgery under general anaesthesia at the end of surgery before extubation. It is given in caudal epidural space, accessed through the sacral hiatus and injecting with 0.2 percent of ropivacaine at 0.75 ml per kg diluted with 0.5ml of normal saline. Each intervention takes upto 15 min. 
Comparator Agent  Caudal block with dexmedetomidine 0.5 mcg per kg  Caudal block given in pediatric patient undergoing lower abdominal and perineal surgery under general anaesthesia at the end of surgery before extubation. It is given in caudal epidural space, accessed through the sacral hiatus and injecting with 0.2 percent ropivacaine 0.75 ml per kg with dexmedetomidine 0.5 mcg per kg diluted with normal saline to 0.5ml. Each intervention takes upto 15 min. 
Comparator Agent  Caudal block with dexmedetomidine 1 mcg per kg  Caudal block given in pediatric patient undergoing lower abdominal and perineal surgery under general anaesthesia at the end of surgery before extubation. It is given in caudal epidural space, accessed through the sacral hiatus and injecting with 0.2 percent ropivacaine 0.75 ml per kg with dexmedetomidine 1 mcg per kg diluted with normal saline to 0.5ml. Each intervention takes upto 15 min. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  a. Assessed patients of ASA physical status I and II.
b. Normal biochemical and hematological parameters.
c. Age group between 2-6 years.
d. Lower abdominal and perineal surgeries, lasting one to three hours under general anaesthesia
f. Informed written conset from legal guardian 
 
ExclusionCriteria 
Details  a. Parent/legal guardian not willing
b. Sacral abnormalities
c. Patients with coagulopathies
d. History of allergy to study drug
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To record the time of requirement of first rescue
analgesic 		 Visual Analogue Scale Score
Just after extubation
1hours post surgery
2hours post surgery
6hours post surgery
12hours post surgery
24hours post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
a) To record the hemodynamic parameters systolic blood pressure, diastolic blood pressure, heart rate and MAP

b) To record incidence of adverse effects i.e. hypotension, bradycardia and sedation 		 Baseline
5 minutes after caudal block
10 minutes after caudal block
15 minutes after caudal block
30 minutes after caudal block
60 minutes after caudal block
2 hours after caudal block
6 hours after caudal block
12 hours after caudal block
24 hours after caudal block 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   13/05/2025 
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   Pediatric patients require specific attention when it comes to postoperative analgesia and  caudal block as a central nerve block technique, is one of the common methods performed to  manage perioperative pain in pediatric lower abdominal and perineal surgeries. Local  anesthetics have usually been the main drug in such cases, and if administered alone in the  caudal blockade, they do not usually provide prolonged analgesia. Ropivacaine is one of the most common drugs in this group. The addition of dexmedetomidine to local anesthetics or its administration as  an adjunct for pain management in a variety of techniques enhances their effects. This study will be carried out to compare the efficacy of ropivacaine with different doses of  dexmedetomidine in caudal block for pediatric lower abdominal and perineal surgeries. 
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