| CTRI Number |
CTRI/2020/07/026307 [Registered on: 02/07/2020] Trial Registered Prospectively |
| Last Modified On: |
28/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to compare the painless duration after surgeries which are performed below navel when a nerve block is given with or without drug dexamethasone through a vein along with complete loss of consciousness |
|
Scientific Title of Study
|
Comparison of duration of postoperative analgesia after caudal block with or without intravenous dexamethasone in paediatric day care infraumbilical surgeries under general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nidhi Sharma |
| Designation |
post graduate resident |
| Affiliation |
ABVIMS and Dr. RML hospital |
| Address |
Department of anaesthesia
ABVIMS and Dr. RML hospital
New delhi -110001
Central
DELHI
110001
India |
| Phone |
7792884099 |
| Fax |
|
| Email |
nidhisharma89201@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha Kachru |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. RML hospital |
| Address |
Department of anaesthesia
ABVIMS and Dr. RML hospital
New delhi -110001
Central
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
nishakachru@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Sharma |
| Designation |
post graduate resident |
| Affiliation |
ABVIMS and Dr. RML hospital |
| Address |
Department of anaesthesia
ABVIMS and Dr. RML hospital
New delhi -110001
Central
DELHI
110001
India |
| Phone |
7792884099 |
| Fax |
|
| Email |
nidhisharma89201@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr. RML hospital
New delhi-110001 |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr RML Hospital |
| Address |
ABVIMS and Dr. RML Hospital
baba kharak singh road
type-iii,connaught place,
new delhi-110001 |
| 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 |
| Dr Nidhi Sharma |
ABVIMS and Dr. RML hospital |
Department of anaesthesia
ABVIMA and Dr. RML hospital
connaught place ,New delhi-110001
Central
DELHI |
7792884099
nidhisharma89201@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| institutional ethical committee ,PGIMER ,Dr.RML hospital |
Approved |
| institutional ethical committee ,PGIMER ,Dr.RML hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Effect of intravenous Dexamethasone on addition to caudal block is compared with just caudal block n paediatric patient. |
Two groups are being compared with and without dexamethasone being added to caudal block. |
| Intervention |
Intravenous Dexamethasone given to patient along with caudal block |
A total of 30 pediatric patients will be given i.v. Dexamethasone in a dose of 0.2 mg/kg in 5 ml normal saline along with caudal block with 0.75 ml/kg of 0.25% bupivacaine in one group
And other group of patient will not be given dexamethasone . Only bupivacaine will be given in 0.75 ml/kg of 0.25% bupivacaine
Frequency -once for a patient . Dose will not be repeated .
Duration of therapy-only once at the beginning of surgery, drug will be given . |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2
patients undergoing elective infra umbilical surgeries
duraion of surgery within 120 minutes
|
|
| ExclusionCriteria |
| Details |
allergic to local anaesthetic drugs
coagulopathy and bleeding disorders
local site infection
preexisting neuromuscular disorders
congenital anomaly of lower back
mental retardation/delayed development |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of post operative analgesia and time for first rescue analgesia. |
Baseline, and then every 15 minutes intraoperatively and hourly postoperatively,until FLACC score is greater than or equal to 4. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
total duration of post operative analgesia until rescue analgesia s given.
Incidence of PONV
parent satisfaction using Likert scale. |
first time when rescue analgesia is given.
Any occasion of nausea or vomiting reported untilthe effect of caudal block is present |
|
|
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)
|
15/07/2020 |
| 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)
|
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)?
|
|
Brief Summary
|
The aim of the study is to study the effect of intravenous dexamethasone on duration of post operative analgesia after intra operative caudal block in paediatric day care infra umbilical surgeries under general anaesthesia. primary objective of which is to determine the duration of post operative analgesia and secondary objective is to assess the incidence of Post operaive nausea and vomiting. |