| CTRI Number |
CTRI/2025/04/085658 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the two different regional analgesia techniques in children undergoing lower abdominal surgeries |
|
Scientific Title of Study
|
A Randomized Controlled Trial comparing the analgesic effects of Sacral Erector Spinae Block and Caudal Block in Pediatric Genitourinary and Perineal Surgeries |
| 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 Aikta Gupta |
| Designation |
Specialist Grade 1 |
| Affiliation |
Chacha Nehru Bal Chikitsalaya |
| Address |
Department of Anaesthesiology, Chacha Nehru Bal Chikitsalaya, Geeta Colony, New Delhi,
East
DELHI
110031
India |
| Phone |
9643308230 |
| Fax |
|
| Email |
aiktab@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu |
| Designation |
Fellow Pediatric Anesthesia |
| Affiliation |
Chacha Nehru Bal Chikitsalaya |
| Address |
Department of Anaesthesiology, Chacha Nehru Bal Chikitsalaya, Geeta Colony, New Delhi
East
DELHI
110031
India |
| Phone |
9810544458 |
| Fax |
|
| Email |
drcharu.nov@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charu |
| Designation |
Fellow Pediatric Anesthesia |
| Affiliation |
Chacha Nehru Bal Chikitsalaya |
| Address |
Department of Anaesthesiology, Chacha Nehru Bal Chikitsalaya, Geeta Colony, New Delhi
East
DELHI
110031
India |
| Phone |
9810544458 |
| Fax |
|
| Email |
drcharu.nov@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Chacha Nehru Bal Chikitsalaya, Geeta Colony, New Delhi, 110031. |
|
|
Primary Sponsor
|
| Name |
Chacha Nehru Bal Chikitsalaya |
| Address |
Department of Anesthesiology, Chacha Nehru Bal Chikitsalaya, Geeta Colony, New Delhi, 110031 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Charu |
Chacha Nehru Bal Chikitsalaya |
Department of Anesthesiology, 2nd floor, Ward block, Chacha Nehru Bal Chikitsalaya, Raja Ram Kohli Marg, Geeta Colony, New Delhi, 110031.
East
DELHI |
9810544458
drcharu.nov@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chacha Nehru Bal Chikitsalaya, 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 |
| Comparator Agent |
Caudal Block |
Dose- 0.75ml/kg of 0.25% isobaric bupivacaine, given using landmark technique.
Frequency- single injection
Timing- after induction of general anesthesia
Duration of analgesia- 4-8 hours |
| Intervention |
Sacral Erector Spinae Block |
Dose- 0.75ml/kg of 0.25% isobaric bupivacaine, at the level of S4 under ultrasound guidance
Frequency- single injection
Timing- after induction of general anesthesia
Duration of analgesia- 4-8 hours |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Patients with American Anesthesiology Society (ASA) physical status I and II.
Patients posted for elective genitourinary- like uretheroplasty and perineal surgery- like anoplasty, vaginoplasty and posterior sagittal anorectoplasty (PSARP)
|
|
| ExclusionCriteria |
| Details |
Patients with significant renal, hepatic, bleeding disorder, skeletal muscles disorder or any other neurological deficit e.g. mental retardation.
Patients having known allergy to study drug.
Contraindication to regional block.
Day care surgeries like circumcision, stent removal etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of analgesia between the two groups in the form of time to first rescue analgesia. |
Pain (FLACC) scoring will be done at admission in PACU, then every 30 minutes till 2 hours then at 4, 8 and 24 hours. Time to first rescue analgesia will be noted. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine & compare between the two groups, intraoperative hemodynamic changes, postoperative pain scores & incidence of any complication |
The vitals including HR, NIBP, SpO2 & end tidal carbon dioxide levels (EtCO2) will be recorded intraoperatively from the induction of anesthesia at every 15 minutes. Pain (FLACC) scoring will be done at admission in PACU, then every 30 minutes till 2 hours then at 4, 8 & 24 hours. Any complication like vomiting, bradycardia, respiratory depression will be noted |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
05/05/2025 |
| 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 Yet Recruiting |
| 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
|
Pediatric
perineal and genitourinary surgeries are extensive and painful requiring
adequate analgesia in the perioperative period. Caudal block has remained the
standard and effective method of managing perioperative analgesia, however, it
has few serious risks associated. The newer Erector Spinae Block (ESPB) has
been established in adults as well as in pediatrics at various spinal levels
and has proven to have safer profile with no involvement of any adjacent vital
structures. There is limited literature present comparing the sacral ESPB and
caudal block in pediatric surgeries.
The hypothesis of this study is that sacral ESPB
can provide comparable analgesic effects to caudal block in pediatric patients
undergoing genitourinary and perineal surgeries, as measured by the duration of
postoperative analgesia, pain scores and the need for rescue analgesics with
better safety margin. |