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CTRI Number  CTRI/2024/05/068090 [Registered on: 30/05/2024] Trial Registered Prospectively
Last Modified On: 29/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study of pain relief effect with addition of Dexmedetomidine to Ropivacaine in Paravertebral Block in kidney surgeries in children. 
Scientific Title of Study   Evaluation Of Analgesic Efficacy Of Dexmedetomidine As An Adjuvant To Ropivacaine in Paravertebral Block in Renal Surgeries in Paediatric Population: A Randomized Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhumika Kalra 
Designation  Assistant Professor 
Affiliation  Chacha Nehru Bal Chikitsalaya 
Address  Room no. 244,operation theatre complex,2nd floor,CNBC hopsital,Geeta Colony,New Delhi.
Raja Ram Kohli Marg,Geeta Colony,New DElhi,110031
East
DELHI
110031
India 
Phone  9810847992  
Fax    
Email  bhumikakalra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sinjini Agarwal 
Designation  Fellow,Paedaitric Anaesthesia 
Affiliation  Chacha Nehru Bal Chikitsalaya 
Address  Room no. 244,operation theatre complex,2nd floor,CNBC hopsital,Geeta Colony,New Delhi.
Raja Ram Kohli Marg,Geeta Colony,New DElhi,110031
East
DELHI
110031
India 
Phone  9177855898  
Fax    
Email  drsinjini.02@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bhumika Kalra 
Designation  Assistant Professor 
Affiliation  Chacha Nehru Bal Chikitsalaya 
Address  Room no. 244,operation theatre complex,2nd floor,CNBC hopsital,Geeta Colony,New Delhi.
Raja Ram Kohli Marg,Geeta Colony,New DElhi,110031
East
DELHI
110031
India 
Phone  9810847992  
Fax    
Email  bhumikakalra@gmail.com  
 
Source of Monetary or Material Support  
Chacha Nehru Bal Chikitsalaya,Raja Ram Kohli Marg,Geeta colony,New Delhi,110031 
 
Primary Sponsor  
Name  Chacha Nehru Bal Chikitsalaya 
Address  Raja Ram Kohli Marg,Geeta Colony,New Delhi,110031 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Chacha Nehru Bal Chikitsalaya  Raja Ram Kohli Marg,Geeta Colony,New Delhi,110031 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrBhumika Kalra  Chacha Nehru Bal Chikitsalaya,Hospital  Room no.244,2nd floor,operation theatre complex,Raja Ram Kohli Marg,Geeta Colony,110031
East
DELHI 		 9810847992

bhumikakalra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Chacha Nehru Bal Chikitsalaya  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  Paravertebral block with Ropivacaine plus Dexmedetomidine.   We will be putting paravertebral block with ropivacaine (0.5 ml/kg) plus dexmedetomidine( 1mcg /kg) in test group. -Dose of Ropivacaine : 0.5 ml/kg plus dexmedetomidine 1mcg /kg -Frequency of administration : Single shot drug. -Route of administration:Through Paravertebral block under USG guidance. -Total Duration of intervention : 24 hours in the postoperative period.  
Comparator Agent  Paravertebral block with ropivacaine.  We will be putting paravertebral block with Ropivacaine (0.5 ml/kg) in control group. -Dose of Ropivacaine : 0.5 ml/kg -Frequency of administration : Single shot drug. -Route of administration:Through Paravertebral block under USG guidance. -Total Duration of intervention : 24 hours in the postoperative period.  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1) Children aged 2-12 years undergoing renal surgeries.
2) ASA physical status grade I and II. 
 
ExclusionCriteria 
Details  1) any contraindications for paravertebral block ( infection at the injection site, kyphoscoliosis, history of bleeding disorders,patients on anticoagulants,history of drug allergy.)
2) Patients on chronic analgesics. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Time to first rescue analgesic requirement in the postoperative period.  First 24 hours in post operative period. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Total consumption of analgesics in postoperative period for 24 hours.
2. Intraoperative opioid consumption.
3. Pain scores in the postoperative period for 24 hours.
4. Satisfaction score for pain relief - good /average /poor.
5. Untoward effects if any - hypotension, bradycardia, sedation, vomiting, pneumothorax.
 		 First 24 hours in post operative period 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   20/06/2024 
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="8"
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
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-04-2025 and end date provided 24-09-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
STUDY TITLE: “Evaluation of analgesic efficacy of dexmedetomidine as an adjuvant to ropivacaine in paravertebral block in renal surgeries in paediatric population: A  randomized clinical trial”

 

INTRODUCTION:

Renal surgeries one of the most commonly performed surgical procedures in children are associated with significant amount of pain. Paravertebral block is an effective analgesic technique used in providing excellent intraoperative as well as postoperative analgesia in children undergoing renal surgeries. The use of ultrasound, has further improved the success rate of the block with excellent visualisation of the structures and also allowing us to visualize local anaesthetic spread. In paediatric population, dexmedetomidine has undoubtedly improved the quality of post-operative analgesia in various studies in peripheral nerve blocks and caudal epidurals.

An extensive search of literature revealed very few studies with regards to the use of dexmedetomidine in paravertebral block in paediatric renal surgeries. Hence the present study is being planned to evaluate the analgesic efficacy of ultrasound guided paravertebral block using dexmedetomidine with ropivacaine in paediatric patients undergoing renal surgeries.

 

AIM:

·       Evaluation of the analgesic efficacy of dexmedetomidine in combination with ropivacaine for single-shot paravertebral block in pediatric patients undergoing renal surgeries.

 

OBJECTIVES:

Primary Objective:

·        To compare the time to first rescue analgesia in patients receiving paravertebral block with ropivacaine with or without dexmedetomidine after receiving general anaesthesia(GA) for renal surgeries.

Secondary objectives:

1.      To compare the postoperative pain scores in patients receiving paravertebral block with ropivacaine with or without dexmedetomidine after receiving GA for renal surgeries.

2.      To compare the incidence of any complications (hypotension, bradycardia, pneumothorax, nausea and vomiting) related to the anaesthetic techniques in the two groups.STUDY TITLE: “Evaluation of analgesic efficacy of dexmedetomidine as an adjuvant to ropivacaine in paravertebral block in renal surgeries in paediatric population: A  randomized clinical trial”

 

INTRODUCTION:

Renal surgeries one of the most commonly performed surgical procedures in children are associated with significant amount of pain. Paravertebral block is an effective analgesic technique used in providing excellent intraoperative as well as postoperative analgesia in children undergoing renal surgeries. The use of ultrasound, has further improved the success rate of the block with excellent visualisation of the structures and also allowing us to visualize local anaesthetic spread. In paediatric population, dexmedetomidine has undoubtedly improved the quality of post-operative analgesia in various studies in peripheral nerve blocks and caudal epidurals.

An extensive search of literature revealed very few studies with regards to the use of dexmedetomidine in paravertebral block in paediatric renal surgeries. Hence the present study is being planned to evaluate the analgesic efficacy of ultrasound guided paravertebral block using dexmedetomidine with ropivacaine in paediatric patients undergoing renal surgeries.

 

AIM:

·       Evaluation of the analgesic efficacy of dexmedetomidine in combination with ropivacaine for single-shot paravertebral block in pediatric patients undergoing renal surgeries.

 

OBJECTIVES:

Primary Objective:

·        To compare the time to first rescue analgesia in patients receiving paravertebral block with ropivacaine with or without dexmedetomidine after receiving general anaesthesia(GA) for renal surgeries.

Secondary objectives:

1.      To compare the postoperative pain scores in patients receiving paravertebral block with ropivacaine with or without dexmedetomidine after receiving GA for renal surgeries.

2.      To compare the incidence of any complications (hypotension, bradycardia, pneumothorax, nausea and vomiting) related to the anaesthetic techniques in the two groups.

MATERIALS AND METHODS:

Study Design: Hospital-based, prospective, randomized, double-blind controlled study.

Study Period: April 2024 to December 2024

Place of Study: Department of Anaesthesia, Chacha Nehru Bal Chikitsalaya, New Delhi

 

Inclusion Criteria:

1.     Children aged 2-12 years undergoing renal surgeries.

2.     ASA  physical status grade I and II

 

Exclusion Criteria:

1.     Any contraindications for paravertebral block (infection at the injection site, kyphoscoliosis, history of bleeding disorders, patients on anticoagulants, history of drug allergy.)

2.     Patients taking chronic analgesics.

 

Methodology: 40 patients will be allocated in two groups of 20 each.

Group A         Patients will receive ultrasound guided paravertebral block with 0.2% ropivacaine 0.5 ml/kg with 0.5 ml normal saline.

Group B         Patients will receive ultrasound guided paravertebral block with 0.2% ropivacaine 0.5 ml/kg + 1 mcg/kg of dexmedetomidine in a volume of 0.5 ml. 

We will compare the two groups in terms of time to first analgesic request, pain scores and the total consumption of analgesics in the postoperative period for 24 hours.

 

Outcomes Measures:

Primary Outcome:

Time to first analgesic requirement in the postoperative period.

Secondary Outcome:

1. Total consumption of analgesics in postoperative period for 24 hours.

2. Intraoperative opioid consumption.

3. Pain scores in the postoperative period for 24 hours.

4. Satisfaction score for pain relief - good /average /poor.

5. Untoward effects if any - hypotension, bradycardia, sedation, vomiting, pneumothorax.

Statistical Tests:

Statistical analysis will be performed by the freely available statistics software on the internet. Normally distributed continuous variables will be compared using the unpaired t test, whereas the Mann-Whitney U test will be used for those variables that will not be normally distributed. Categorical variables will be analysed using either the chi square test or Fisher’s exact test. P<0.05 will be considered statistically significant.

 

 

                                   

       

 
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