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CTRI Number  CTRI/2021/09/036281 [Registered on: 07/09/2021] Trial Registered Prospectively
Last Modified On: 06/09/2021
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   COMPARATIVE EVALUATION OF POSTOPERATIVE ANALGESIC EFFECT OF 0.5% ROPIVACAINE PLAIN OR WITH ADDITION OF DEXAMETHASONE FOR POPLITEAL SCIATIC NERVE BLOCK IN PAEDIATRIC ANKLE AND FOOT SURGERIES. 
Scientific Title of Study   COMPARATIVE EVALUATION OF ANALGESIC EFFECT OF 0.5% ROPIVACAINE WITH OR WITHOUT DEXAMETHASONE FOR POPLITEAL SCIATIC NERVE BLOCK IN PAEDIATRIC ANKLE AND FOOT SURGERIES. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Venkatesh chowdari 
Designation  Post graduate resident 
Affiliation  Vardhaman mahavir medical college and Safdarjung hospital Newdelhi 
Address  Dept of anaesthesia

New Delhi
DELHI
110029
India 
Phone  7892752123  
Fax    
Email  venkateshchowdary.ch@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrRama wason 
Designation  Professor 
Affiliation  Vardhaman mahavir medical college and Safdarjung hospital Newdelhi 
Address  Dept of anaesthesia

New Delhi
DELHI
110029
India 
Phone  7892752123  
Fax    
Email  nupur4@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Venkatesh chowdari 
Designation  Post graduate resident 
Affiliation  Vardhaman mahavir medical college and Safdarjung hospital Newdelhi 
Address  Dept of anaesthesia

New Delhi
DELHI
110029
India 
Phone  7892752123  
Fax    
Email  venkateshchowdary.ch@gmail.com  
 
Source of Monetary or Material Support  
Vardhaman mahavir medical college and Safdarjung hospital Newdelhi 
 
Primary Sponsor  
Name  Vardhaman mahavir medical college and Safdarjung hospital 
Address  Vardhaman mahavir medical college and Safdarjung hospital newdelhi 110029 
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 
Drvenkatesh chowdari  Safdarjung hospital  Operation theatre complex,New emergency building,vmmc and Sjh newdelhi
New Delhi
DELHI 
7892752123

venkateshchowdary.ch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC/VMMC/SJH/Thesis/2020-03/CC-125  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, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.5% ROPIVACAINE PLAIN  Dose of ropivacaine:2mg/kg Route:around division of popliteal sciatic nerve locally Frequency:1 Duration:24hours 
Comparator Agent  0.5%ROPIVACAINE 2MG/KG WITH DEXAMETHASONE 0.1MG/KG   Dose of dexamethasone:0.1mg/kg Route:around division of popliteal sciatic nerve locally Frequency:1 Duration:24hours 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Asa grade 1and2 of either gender undergoing elective foot and ankle surgeries under GA 
 
ExclusionCriteria 
Details  Infection at planned injection site
Existing peripheral neuropathy
Known allergy to LA or dexamethasone 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare duration of analgesia by addition of dexamethasone to 0.5%ropivacaine to using 0.5%ropivacaine plain alone for popliteal sciatic nerve block in children undergoing foot and ankle surgeries as assessed by time to first rescue analgesic requirement
 
at baseline,24hrs. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare quality of analgesia b/w two groups by adding dexamethasone to 0.5% ropivacaine than using 0.5%ropivacaine plain for popliteal sciatic nerve block in children undergoing foot and ankle surgeries using VAS score(6-12years) OPS score(0-6yrs)at rest and movement

Requirement of additional analgesia over 24hrs 
Every 1hourly  
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/09/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
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 - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 [venkateshchowdary.ch@gmail.com].

  6. For how long will this data be available start date provided 23-03-2021 and end date provided 23-03-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
METHODOLOGY:
All patients who meet the inclusion criteria will undergo pre anaesthetic evaluation as per the protocol of the department
A written informed consent from parents will be taken.
All patients will be nil per oral for 6 hours for solid food and 4 hours for clear liquids as per NPO guidelines. Premedication will be given as syrup phenargan0.5mg/kg 30min before surgery
Patient will be shifted to operating room.Standard monitoring  like ECG leads, NIBP, Pulseoximeter will be attached and preoperative baseline parameters recorded.
Inhalational induction with sevoflurane and 100%02 will be done, IV line will be secured,  Fentanyl citrate 2mcg/kg will be given (over 30 second) and After ensuring check ventilation, vecuronium 0.1mg/kg will be administered intravenously. Patient will be ventilated with mixture of oxygen + N2O(50:50) for 3 min and then laryngeal mask airway of appropriate size will be inserted. After confirming bilateral equal air entry, the laryngeal mask airway will be fixed and normocapnic ventilation will be started with monitoring of vitals.
Under all aseptic precaution cleaning and draping will be done, sterile cover for ultrasound probe.The goal is to inject the local anaesthetic within the common connective tissue(VLOKA’S) sheath that envelops the tibial and common peroneal nerve
The Popliteal fossa has semitendinosus, semimembranosus medially and biceps femoris laterally. Linear transducer of straight array[10to14MHz] oriented in the short axis placed in popliteal fossa.Identify Popliteal artery and vein deeper in the region will be identified,The nerves are lateral and superficial to vessels.
The needle will be approached  from lateral to medial with patient in supine position with knee flexed.
LA CHOICE AND DOSAGE:
           Dose of ropivacaine:2mg/kg
           Dose of dexamethasone:0.1mg/kg
If either HR or BP increased to 20% more than post induction or pre block levels, Fentanyl 0.5-1mcg/kg will be administered and repeated as required. 
Patients will be classified as having pain on the basis of tw scoroing systems: OPS[0-6years] and VAS[6-12years].Half an hour before end of surgery patient will receive Inj. Paracetamol 7.5mg/kg for patients <10kg body weight and 15mg/kg for patients >10kg body weight. Reversal will be achieved with inj.neostigmine[50mic/kg] and inj.glycopyrrolate[10mic/kg] prosealLMA removal will be done after return of adequate reflexes. 
Postoperatively pain assessment using VAS[6-12YRS] OR OPS[0-6YRS] AT T0,T30min,T1,2,4,6,12,24hrs respectively will be administered for an age appropriate pain score( VAS/OPS  depending upon the age group) of between 4 TO 6(0–10) and Inj. Tramadol 1mg/kg  intravenously for a score >6 . Before giving Tramadol Inj. Ondansetron 0.1mg/kg administered to prevent vomiting.The same general protocol will be followed in the post operative ward for 24 hour. Time to first resque analgesic requirement will be noted and additional doses of analgesic requirements over 24hrs and side effects like nausea,vomiting etc.will be noted.

 
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