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CTRI Number  CTRI/2019/08/020998 [Registered on: 30/08/2019] Trial Registered Prospectively
Last Modified On: 25/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two different blocks and pain relief provided by them in children. 
Scientific Title of Study   Comparison of single injection of erector spinae plane block and paravertebral block in reducing post operative pain in children: a prospective, double blinded, randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arlin Baby Thomas 
Designation  PG Registrar in Anaesthesiology 
Affiliation  Christian Medical College, Vellore 
Address  Department of Anaesthesiology, Christian Medical College and Hospital, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8628030418  
Fax    
Email  arlinthomas@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ekta Rai 
Designation  Professor in Anaesthesiology 
Affiliation  Christian Medical College, Vellore 
Address  Department of Anaesthesiology, Christian Medical College and Hospital, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9789250113  
Fax    
Email  drektarai@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ekta Rai 
Designation  Professor in Anaesthesiology 
Affiliation  Christian Medical College, Vellore 
Address  Department of Anaesthesiology, Christian Medical College and Hospital, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9789250113  
Fax    
Email  drektarai@yahoo.com  
 
Source of Monetary or Material Support  
Seed Research Grant, Research committee, Christian Medical College, Vellore - 632004 
 
Primary Sponsor  
Name  Fluid Research Grant 
Address  Christian Medical College, Vellore 
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 
Arlin Baby Thomas  christian medical college  department of anaesthesiology, paediatric division
Vellore
TAMIL NADU 
8628030418

arlinthomas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE CMC VELLORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q623||Other obstructive defects of renalpelvis and ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intervention agent 1   Erector spinae plane block 
Comparator Agent  Intervention agent 2  Paravertebral Block 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. ASA I, II
2. children of age group 1-15 years
3. patients undergoing pyeloplasty or simple nephrectomy 
 
ExclusionCriteria 
Details  1. Infection at the site of injection
2. Coagulopathy
3. Abnormal anatomy
4. Allergy to local anesthetics 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the difference in the pain in children aged 1 to 15 years undergoing open pyeloplasty or simple nephrectomy, after receiving single injection of either erector spinae plane block or paravertebral block intra operatively.  upto 48 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the time to first post operative rescue analgesia and the total dose of post operative analgesics needed in the first 48 hours after operation in both groups.  upto 48 hours postoperatively 
To compare the time needed to perform the blocks under ultrasound.  intraoperatively 
To compare the effect of the blocks on hemodynamic changes from baseline, during skin incision, at 15 minutes interval intraoperatively till the procedure is over.  intraoperatively 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3 
Date of First Enrollment (India)   02/09/2019 
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)
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)?  

Brief Summary  

BACKGROUND: Post operative pain is an inevitable consequence of surgery even in children. The length of the incision causes significant post operative pain in children after pyeloplasty and simple nephrectomy. Both erector spinae plane block and paravertebral block have been proven to be effective in providing post operative analgesia. However no comparison studies have been done on their analgesic efficacy.

AIM: We aim to compare the effects of single injection of erector spinae plane block and paravertebral block on post operative pain and analgesic requirements in children after open pyeloplasty and simple nephrectomy.

STUDY DESIGN: double blinded, prospective, randomised controlled trial

MATERIAL AND METHODS: a total of 100 American society of Anesthesiologists physical status 1 and 2  paediatric patients, aged 1-15 years,  scheduled to undergo open pyeloplasty or simple nephrectomy will be randomly allocated to receive either erector spinae plane block (Group A: n = 50) or paravertebral block (Group B: n=50) with 0.2% ropivacaine 0.8ml/kg and 0.5ml/kg respectively pre operatively post induction of general anesthesia. A standard protocol will be used to provide general anesthesia. Post operatively FLACC (faces, legs, activity, cry, consolability) score or VAS (visual analog score) will be used for pain assessment according to age of the patient at 0, 1, 2, 6, 12, 18, 24, 36, 48 hours and one week later on follow up. The time to first rescue analgesia, total analgesic requirement, time taken to perform the blocks, intraoperative hemodynamic changes and post operative parental and surgeon satisfactions will be assessed. Data collected will be entered in Epidata software and analysed.

 
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