| CTRI Number |
CTRI/2024/03/064739 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of local anaesthetic volume requirement for paediatric caudal block when given based on armitage formula and under ultrasound guided assessment. |
|
Scientific Title of Study
|
To study the difference in the volume of local anaesthetic required for cranial spread during caudal block in children using ultrasound guided assessment as compared to a precalculated volume. |
| 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 Mikhila Lizbet |
| Designation |
Resident |
| Affiliation |
Aster CMI Hospital, Banglore |
| Address |
Second floor,Department of Anaesthesia,Aster CMI Hospital,Hebbal,Bangalore, Karnataka
Bangalore
KARNATAKA
560092
India |
| Phone |
9400418140 |
| Fax |
|
| Email |
mikhilla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Gaurang J Kothari |
| Designation |
Consultant |
| Affiliation |
Aster CMI Hospital, Banglore |
| Address |
Department of Anaesthesia, Aster CMI Hospital, Benguluru, 560092
Bangalore
KARNATAKA
560092
India |
| Phone |
|
| Fax |
|
| Email |
gaurangkothari29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shyamala |
| Designation |
DNB coordinator |
| Affiliation |
Aster CMI Hospital, Banglore |
| Address |
Aster CMI Hospital, Benguluru, 560092
Bangalore
KARNATAKA
560092
India |
| Phone |
|
| Fax |
|
| Email |
academics.blr@asterhospital.com |
|
|
Source of Monetary or Material Support
|
| Aster CMI Hospital
Hebbal, Bangalore
560092 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Gaurang J Kothari |
ASTER CMI HOSPITAL |
Department of Anaesthesia,Second Floor.
Benguluru
BANGLORE , 560092
Bangalore
KARNATAKA |
8105885778
gaurangkothari29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aster CMI Institutional Ethics Committee |
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 |
| Intervention |
Ultrasound guided caudal block. |
Ultrasound guided injection of 0.2% Ropivacaine into caudal space/epidural space from a syringe loaded with precalculated volume of local anesthetic based on Armitage formula that is 0.5ml/kg for sacral level,1ml/kg for lumbar level and 1.25ml/kg for lower thoracic postoperative pain is assessed for 8 hours after surgery. |
| Comparator Agent |
Volume of local anaesthetic agent |
Comparison of volume of local anesthetic agent required under ultrasound guided caudal block and Armitage formula based precalculated volume and the postoperative pain is assessed for 8 hours after surgery. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children between the age group of neonates to 6 years under ASA I-II undergoing abdominal, perineal and lower limb surgeries. |
|
| ExclusionCriteria |
| Details |
PARENTAL REFUSAL
COAGULATION DISORDER
LOCAL SITE INFECTION
ANATOMICAL ABNORMALITIES |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Comparison of Local anaesthetic volume requirement as per Armitage formula and Ultrasound guided caudal block. |
Comparison of local anaesthetic volume is done during the procedure and the pain assessment is done after one hour, three hours and lastly after 8 hours after the surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain assessment using FLACC score & Heartrate |
First hour Third hour & Sixth hour after surgery. |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
Final Enrollment numbers achieved (Total)= "65"
Final Enrollment numbers achieved (India)="65" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/03/2024 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/04/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 comparison of difference in the volume of local anaesthetic required for caudal block in paediatric population under ultrasound guidance and Armitage formula based precalculated volume. Thereby reducing the complications assosciated with local anesthetic , same time ensuring adequate postop analgesia. |