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CTRI Number  CTRI/2018/03/012527 [Registered on: 13/03/2018] Trial Registered Prospectively
Last Modified On: 12/03/2018
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   Comparison of analgesia with erector spine and quadratus lumborum block in pyeloplasty surgery in children 
Scientific Title of Study   Comparison of analgesic efficacy of Ultrasound Guided QuadratusLumborum Block (QL) versus Erector Spinae Plane (ESP) Block in children undergoing open pyeloplasty – Randomized Double Blinded Control  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Isaac Lalfakzuala Ralte 
Designation  Junior Resident 
Affiliation  AIIMS , New Delhi 
Address  Department of Anesthesiology , Pain Medicine And Critical Care AIIMS , New Delhi

South
DELHI
110029
India 
Phone  9910129163  
Fax    
Email  isaaclalfakzuala@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Praveen Talawar 
Designation  Assisstant Professor 
Affiliation  AIIMS , New Delhi 
Address  Department of Anesthesiology , Pain Medicine And Critical Care

South
DELHI
110029
India 
Phone  9654162941  
Fax    
Email  praveenrt64@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Praveen Talawar 
Designation  Assisstant Professor 
Affiliation  AIIMS , New Delhi 
Address  Department of Anesthesiology , Pain Medicine And Critical Care

South
DELHI
110029
India 
Phone  9654162941  
Fax    
Email  praveenrt64@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology , Pain Medicine and Critical Care , AIIMS New Delhi 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Department of Anesthesiology , Pain Medicine and Critical Care 
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 Isaac  AIIMS New Delhi  Room No 5011 5th Floor Teaching Block AIIMS Ansari Nagar New Delhi 110029
South
DELHI 		 9910129163

isaaclafakzuala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee , AIIMS , New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Children age 1 to 6 years old undergoing pyeloplasty,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Quadratus lumborum (QL) block versus Erector spinae plane (ESP) block  both groups will receive 0.5ml/kg of 0.25% ropivacaine patient is observed till 24 hour post operative period 
Comparator Agent  Ultrasound guided Erector Spine Plane (ESP) block   0.5ml/kg of 0.25% ropivacaine 
Comparator Agent  Ultrasound guided Quadratus lumborum (QL) block- Trans muscular approach  0.5ml/kg of 0.25% ropivacaine 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1.ASA I & II
2. Elective Open Pyeloplasty 
 
ExclusionCriteria 
Details  1.Refusal by parents or guardians to participate in the study
2.Developmental delay and mental retardation
3.Coagulopathy
4.Infection at the puncture site
5.Significant cardiac, renal and liver diseases
6.Obesity

 
 
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 
Pain scores as measured by Modified Objective Pain Scale in first 24 hour after the surgery
 		 0, 1, 2, 4, 6, 12 and 24 hour after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Intraoperative fentanyl (rescue analgesia) requirements

Post operative fentanyl (rescue analgesia) requirements

Haemodynamic measurements among the groups

Post operative nausea, vomiting and any complications related to the block 		 Intra-operatively- every 5 minutes

Post operatively- 0, 1, 2, 4, 6, 12 and 24 hours after surgery 
 
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)   01/05/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/04/2018 
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)  Not Yet Recruiting 
Publication Details   1. Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7 2. Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. 3. Jadon A, Jain P and Sinha N . A Case Report : The Erector Spinae Plane Block for Postoperative Analgesia in Abdominoplasty - BAOJ Anesthesia 2017 Vol 1 Issue 1 ; 001 .  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Comparision of analgesic efficacy of ultrasound guided Quadratus Lumborum Block versus Erector Spinae Block in pediatric pyeloplasty
We hypothesize that ESP Block provides superior analgesia compared to QL Block due to its wider spread 
 
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