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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
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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 |
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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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [venkateshchowdary.ch@gmail.com].
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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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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