| CTRI Number |
CTRI/2024/09/073379 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study in which the participants are paediatric patients undergoing infraumbilical surgery with main outcome of the study being postoperative pain relief between ultrasound guided erector spinae plane block and caudal block. |
|
Scientific Title of Study
|
Comparison of ultrasound guided erector spinae plane block and caudal block for postoperative analgesia in paediatric patients undergoing 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. Sumegha Dadala |
| Designation |
Post Graduate Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care
Ground Floor
OT Complex
Vardhman Mahavir Medical College and Safdarjung Hospital
New Delhi
South West
DELHI
110029
India |
| Phone |
9718183039 |
| Fax |
|
| Email |
sumeghadadala25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shipra Aggarwal |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care
Ground Floor
OT Complex
Vardhman Mahavir Medical College and Safdarjung Hospital
DELHI
110029
India |
| Phone |
9811420866 |
| Fax |
|
| Email |
shipra.mamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sumegha Dadala |
| Designation |
Post Graduate Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care
Ground Floor
OT Complex
Vardhman Mahavir Medical College and Safdarjung Hospital
South West
DELHI
110029
India |
| Phone |
9718183039 |
| Fax |
|
| Email |
sumeghadadala25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital
Ansari Nagar East , Near AIIMS metro station
New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital
Ansari Nagar East
Near AIIMS metro station
New Delhi - 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 |
| Dr Sumegha Dadala |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia and Intensive Care
Ground Floor
OT Complex
Ansari Nagar East
Near AIIMS Metro Station
New Delhi - 110029
South West
DELHI |
9718183039
sumeghadadala25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K403||Unilateral inguinal hernia, with obstruction, without gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided caudal block |
A high frequency linear ultrasound will be placed transversely at the midline to obtain a transverse view of the 2 cornua, the sacrococcygeal ligament, sacral bone and sacral hiatus. At the visualization of the frog sign, the ultrasound transducer will be twisted to 90 degrees to obtain longitudinal views of the sacrococcygeal ligament and sacral hiatus, and a 22G 5 cm long stimuplex needle will be inserted into the sacral canal under direct in plane visualization. Then 0.25% bupivacaine 0.5ml/kg will be injected slowly (maximum 2mg/kg). |
| Intervention |
Ultrasound guided erector spinae muscle block |
After identifying the erector spinae muscles and transverse process of the T10 vertebra with a high frequency linear ultrasound transducer, a needle will be inserted with an in-plane technique in the craniocaudal direction. Then a total of 0.25% bupivacaine will be administered between the 10th transverse process and erector spinae muscles using a 22 G, 5 cm long stimuplex needle. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists-Physical Status 1 & 2 patients between 2-7 years of age, weighing 5-20kgs scheduled for elective unilateral infraumbilical surgery requiring less than 90 minutes. |
|
| ExclusionCriteria |
| Details |
1. Children with known spinal anomalies, altered mental status, history of developmental delay.
2. Known drug allergy.
3. Contraindication to the block. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative analgesia by FLACC score |
1 hour postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FLACC score |
0,2,4,6,12 and 24 hours postoperatively |
| First analgesic request |
Postoperatively when required |
| Total analgesic requirement |
first 24 hours postoperatively |
| Intraoperative analgesic requirement |
Intraoperative time when required |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/10/2024 |
| 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 - 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 - Informed Consent Form
Response - Clinical Study Report
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shipra.mamc@gmail.com].
- For how long will this data be available start date provided 05-10-2026 and end date provided 05-10-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a prospective comparative study to compare ultrasound guided erector spinae plane block using 0.5ml/kg of 0.25% bupivacaine and caudal block using 0.5 ml/kg of 0.25% bupivacaine for postoperative analgesia in paediatric patients undergoing infraumbilical surgery that will be conducted in Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi. The primary outcome will be to compare the postoperative analgesia by FLACC score at 1 hour in paediatric patients undergoing infraumbilical surgery receiving ultrasound guided erector spinae plane block and caudal block. The secondary outcomes will be to compare the FLACC score at 0,2,4,6,12 and 24 hours postoperatively, time to first rescue analgesic request, total analgesic requirement in the first 24 hours postoperatively and intraoperative analgesic requirement. |