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CTRI Number  CTRI/2022/03/040794 [Registered on: 04/03/2022] Trial Registered Prospectively
Last Modified On: 31/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Assessment of pain relief in children undergoing hernia surgeries with multiple pain relieving methods using a apin monitor. 
Scientific Title of Study   Evaluation of Multimodal Analgesia Using Analgesia Nociception Index (ANI) Monitoring In Paediatric Patients for Herniotomy under General Anaesthesia: A Prospective Comparative Study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sowmya Madihalli Janardhan Iyengar 
Designation  Professor 
Affiliation  Rajarajeswari Medical College and Hospital 
Address  RajaRajeswari Medical College and Hoapital 202, Mysore Road, Kambipura, Bangalore.
202, Mysore Road, Kambipura, Bangalore 560074
Bangalore
KARNATAKA
560074
India 
Phone  9880574092  
Fax    
Email  drsowmyamj80@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sowmya Madihalli Janardhan Iyengar 
Designation  Professor 
Affiliation  Rajarajeswari Medical College 
Address  RajaRajeswari Medical College, 202, Mysore Road, Kambipura, Bangalore 560074
202, Mysore Road, Kambipura, Bangalore 560074
Bangalore
KARNATAKA
560074
India 
Phone  9880574092  
Fax    
Email  drsowmyamj80@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sowmya Madihalli Janardhan Iyengar 
Designation  Professor 
Affiliation  Rajarajeswari Medical College and Hospital 
Address  RajaRajeswari Medical College and Hospital. 202, Mysore Road, Kambipura, Bangalore 560074
202, Mysore Road, Kambipura, Bangalore 560074
Bangalore
KARNATAKA
560040
India 
Phone  9880574092  
Fax    
Email  drsowmyamj80@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari Medical College and Hospital 
 
Primary Sponsor  
Name  Rajarajeswari Medical College and Hospital 
Address  202,Mysore Road, Kambipura, Bangalore. 560074 
Type of Sponsor  Private 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 
Sowmya M J  Rajarajeswari Medical College and Hospital  Department of Anesthesiology, 2nd Floor, OT Complex, 202, Mysore Road, Kambipura, Bangalore . 560074
Bangalore
KARNATAKA 		 9880574092

drsowmyamj80@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Rajarajeswari medical college and Hospital.  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 
Comparator Agent  Control group- 1.5ml of 0.9% Saline  The surgeon injects 1.5 ml of 0.9% saline at the surgical incision site, 10 minutes before sugical incision. 
Intervention  Local anesthesia with 1.5 ml Injection 0.25% Bupivacaine   The surgeon gives the study drug infiltration at the incision site 10 minutes before the surgical incision.  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1. Children belonging to ASA physical status I aged between 3-8 years.
2. Elective herniotomy
 
 
ExclusionCriteria 
Details  1. Children requiring ketamine, glycopyrrolate, atropine, muscle relaxants, reversal agents
2. Children with fever and recent upper respiratory tract infection
3. Children with cardiac dysrhythmias, neurological diseases, renal, hepatic disease
4. Children with contraindications to regional analgesia (Caudal)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome is adequacy of intraoperative analgesia which is measured by Analgesia Nociceptive index (values between 50 to70 denotes adequate analgesia)
 		 Measured every 5 minutes till the end of surgery.

 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the clinical performance of Analgesia nociceptive Index in the assessment of immediate postoperative analgesia in pediatric patients who have undergone hernia surgeries under general anaesthesia.  intaoperative and immediate post operative period for 2 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   N/A 
Date of First Enrollment (India)   08/03/2022 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This prospective two arm interventional  study will be conducted on pediatric patients undergoing unilateral herniotomy under general anesthesia,  for evaluating the effectiveness of Multimodal analgesia using surgical site skin infiltration along with Caudal analgesia using Analgesia Nociceptive Index (ANI). We hypothesise that multimodal analgeisa provides a superior pain relief and ANI monitor might predict adequacy of postoperative analgesia. 
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