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CTRI Number  CTRI/2025/08/092465 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 05/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study in children undergoing keyhole chest surgery to compare two types of pain relief blocks Rhomboid Intercostal and Sub Serratus Plane Block verses Erector Spinae Plane Block to see which provides better pain control after surgery. 
Scientific Title of Study   Comparison of Rhomboid Intercostal and Sub Serratus Plane Block with Erector Spinae Plane Block for perioperative analgesia in children undergoing Video Assisted Thoracoscopic Surgery under 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 Laxmi Meena  
Designation  Post Graduate Anaesthesia Resident 
Affiliation  Maulana Azad Medical College  
Address  Department of Anaesthesiology, Maulana Azad Medical College, 2, Bahadur Zafar Marg, New Delhi-110002
2, Bahadur Zafar Marg, New Delhi-110002
Central
DELHI
110002
India 
Phone  8178064179  
Fax    
Email  5.106.laxmimeena@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonia Wadhawan 
Designation  Director Professor,Department of Anaesthesiology 
Affiliation  Maulana Azad Medical College  
Address  Department of Anaesthesiology, Maulana Azad Medical College, 2, Bahadur Zafar Marg, New Delhi-110002
2, Bahadur Zafar Marg, New Delhi-110002
Central
DELHI
110002
India 
Phone  9810946845  
Fax    
Email  soniawadhawan@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sonia Wadhawan 
Designation  Director Professor,Department of Anaesthesiology 
Affiliation  Maulana Azad Medical College  
Address  Department of Anaesthesiology, Maulana Azad Medical College, 2, Bahadur Zafar Marg, New Delhi-110002
2, Bahadur Zafar Marg, New Delhi-110002
Central
DELHI
110002
India 
Phone  9810946845  
Fax    
Email  soniawadhawan@hotmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, 3rd Floor no.308, BL Taneja Block, MAMC Campus,2 Bahadurshah Zafar Marg,New Delhi-110002,India 
 
Primary Sponsor  
Name  MAULANA AZAD MEDICAL COLLEGE 
Address  Department of Anaesthesiology, 3rd Floor no.308, BL taneja block, MAMC Campus 
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 Laxmi Meena  LOK NAYAK HOSPITAL ,Maulana Azad Medical College   Department of Anaesthesiology, 3rd Floor no.308, BL Taneja Block, MAMC Campus,2 Bahadurshah Zafar Marg,New Delhi-110002,India.
Central
DELHI 		 8178064179

5.106.laxmimeena@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee F.1/IEC/MAMC/MD/MS/114/02/2025/No.127  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Erector Spinae Plane Block (ESP)  18 children undergoing VATS Procedure will receive Erector Spinae Plane Block along with standard technique. 
Intervention  Rhomboid Intercostal and Sub Serratus Plane Block (RISS)  18 children undergoing VATS Procedure will receive Rhomboid Intercostal and Sub Serratus Plane Block along with standard GA technique. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1.American Society of Anesthesiologists(ASA)grades I,II,III . 
 
ExclusionCriteria 
Details  1.History of bleeding diathesis.
2.Children receiving anticoagulant treatment.
3.Infection at the region of block.
4.Any known allergies to local anaesthetics or opioids. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Total mean intraoperative fentanyl consumption in children undergoing VATS under general anaesthesia receiving either RISS block or ESP block.  Just after completion of Surgery  
 
Secondary Outcome  
Outcome  TimePoints 
Total mean intraoperative consumption of sevoflurane.  Just after completion of Surgery. 
Time at which first rescue dose of analgesia is given.  Post operatively after completion of Surgery. 
Mean post operative pain score using visual analogue scale and FLACC behavioral scale.  At 0, 3, 6, 12 and 24 hrs post operatively. 
Mean serum cortisol and interleukin 6 levels   Preoperative baseline and 6 hrs post block administration. 
Total number of doses of rescue analgesia doses required.  24 hrs post operatively. 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   16/08/2025 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [5.106.laxmimeena@gmail.com].

  6. For how long will this data be available start date provided 27-07-2027 and end date provided 27-07-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Title of the thesis is Comparison of Rhomboid Intercostal and Sub Serratus Plane Block with Erector Spinae Plane Block for perioperative analgesia in children undergoing Video Assisted Thoracoscopic Surgery .Target population is children aged 3-10 yrs old.Study design is Randomized Controlled Trial with sample size 36 (18 in each group).Primary outcome includes total intraoperative fentanyl consumption.Secondary outcomes includes total intraoperative sevoflurane usage, Time to first rescue analgesic usage in post op, post op pain scores, Serum cortisol and IL 6 levels, number of rescue analgesic doses in first 24 hours. 
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