| CTRI Number |
CTRI/2024/07/071128 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to compare bupivacaine alone and bupivacaine- dexamethasone combination in caudal block for pediatric patients undergoing elective infraumbilical surgery |
|
Scientific Title of Study
|
Comparison of caudal bupivacaine alone and caudal bupivacaine- dexamethasone combination for pediatric patients undergoing elective infraumbilical surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bharath T |
| Designation |
PG Resident |
| Affiliation |
|
| Address |
Department of Anesthesia and Intensive Care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8072238544 |
| Fax |
|
| Email |
bharaththanigaivelan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PS Bhatia |
| Designation |
Professor and Consultant |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care, ground floor, main
operation theatre building, Safdarjung Hospital Campus, Ansari
Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7042142230 |
| Fax |
|
| Email |
psbhatia2@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PS Bhatia |
| Designation |
Professor and Consultant |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care, ground floor, main
operation theatre building, Safdarjung Hospital Campus, Ansari
Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7042142230 |
| Fax |
|
| Email |
psbhatia2@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi |
| 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 Bharath |
Vardhman Mahavir medical college and Safdarjung hospital |
Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi
New Delhi
DELHI |
8072238544
bharaththanigaivelan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir medical college and Safdarjung hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison of bupivacaine vs bupivacaine-dexamethasone in caudal block |
By adding dexamethasone to bupivacaine and trying to see whether it prolongs the duration of post operative analgesia in paediatric patients undergoing infra-umbilical surgeries when compared to dexamethasone alone in caudal block |
| Intervention |
Conventional Caudal block for Postoperative analgesia |
pediatric patients undergoing infraumbilical surgery under general anaesthesia will be given caudal block for postoperative analgesia |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged 2-10 years with American society of Anesthesiologists physical status I, II scheduled for elective infraumbilical surgeries |
|
| ExclusionCriteria |
| Details |
1.Infection at the site of the block.
2.Coagulopathy.
3.Allergy to local anesthetics.
4.Pre-existing neurological or spinal disease and abnormalities of the sacrum.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of postoperative analgesia in caudal block using bupivacaine and bupivacaine with dexamethasone by time taken to first rescue analgesia in paediatric patients undergoing elective infraumbilical surgery |
To compare the duration of postoperative analgesia in caudal block using bupivacaine and bupivacaine with dexamethasone by time taken to first rescue analgesia in paediatric patients undergoing elective infraumbilical surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Intraoperative haemodynamic parameters.
2. Total analgesia requirement in the first 24 hours.
|
Intraoperatively every 10 mins the vital parameters will be assessed |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This study is a randomised comparative study to compare the postoperative analgesia between caudal bupivacaine alone and caudal bupivacaIne-dexamethasone in pediatric patients undergoing elective infraumbilical surgery under general anaesthesia, with the hypothesis that the bupivacaine-dexamethasone combination provides better postoperative analgesia than bupivacaine alone in caudal block. Primarily postoperative pain scores (FLACC score) will be recorded at 0hr, 1hr, 2hrs, 4hrs, 8hrs, 12hrs and 24 hrs. Secondarily intraoperative hemodynamic parameters and total analgesic requirement in 24 hrs will be recorded. |