| CTRI Number |
CTRI/2025/09/095411 [Registered on: 25/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| 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 comparing pain relief from two techniques an ultrasound guided sacral erector spinae block and a caudal epidural block in children undergoing urethroplasty surgery under general anesthesia |
|
Scientific Title of Study
|
Analgesic efficacy of ultrasound guided Sacral Erector Spinae Plane Block versus Caudal epidural Block in pediatric patients undergoing urethroplasty under general anesthesia: a randomized controlled study |
| 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 Roopa |
| Designation |
Senior Resident |
| Affiliation |
All Institute Of Medical Sciences Bhopal |
| Address |
Department of Anesthesiology, AIIMS Bhopal. 462020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9986588673 |
| Fax |
|
| Email |
roopagalag97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zainab Ahmad |
| Designation |
Additional Professor |
| Affiliation |
All Institute Of Medical Sciences Bhopal |
| Address |
Department of Anesthesiology, AIIMS Bhopal. 462020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8860048951 |
| Fax |
|
| Email |
drzainabhaq@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zainab Ahmad |
| Designation |
Additional Professor |
| Affiliation |
All Institute Of Medical Sciences Bhopal |
| Address |
Department of Anesthesiology, AIIMS Bhopal. 462020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8860048951 |
| Fax |
|
| Email |
drzainabhaq@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences Bhopal |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences Bhopal |
| Address |
AIIMS campus Saket Nagar Habib Ganj Bhopal Madhya Pradesh 462020 |
| 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 Roopa |
AIIMS Bhopal |
Department of Anesthesiology, 2nd floor modular OT, saket nagar AIIMS Bhopal
Bhopal
MADHYA PRADESH |
9986588673
roopagalag97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee- Student Research (IHEC-SR) Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N37||Urethral disorders in diseases classified elsewhere, (2) ICD-10 Condition: N365||Urethral false passage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound guided Caudal Epidural block |
Patient will be positioned in the lateral position for
the caudal block. Under all aseptic precautions USG guided caudal epidural block will be given using 0.25 percent bupivacaine 1 ml per kg volume with dexmedetomidine 1 microgram per kg |
| Intervention |
Ultrasound guided Sacral Erector Spinae Plane Block |
Patient will be positioned in the lateral position
for block. Under all aseptic precautions USG guided (7–13 MHz linear probe on the
Sonosite™ MTurbo) erector spinae plane block will be given with echogenic 5 cm 22 G needle at the 3rd - 4th median crest with 0.25 percent bupivacaine (1ml perk kg) combined with dexmedetomidine 1microgram per kg after negative aspiration. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Male |
| Details |
• Consenting parents or guardians
• Children from 1 to 8 years of age
• Undergoing urethroplasty surgery with plan of anesthesia as general anesthesia with a regional block
• ASA 1 and 2 patients |
|
| ExclusionCriteria |
| Details |
• Allergy to the study drugs
• Infection or skin changes at the puncture site
• Vertebral anomalies
• Syndromic association
• We wish to exclude age less than 1 year due to technical difficulties expected in this
age group and more than 8yrs due to the expected anatomical difficulties during caudal
epidural block because of progressive ossification of sacrococcygeal ligament) |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
FLACC that is face legs activity cry consolability scale score at different time
points |
at 0hour 1h 2 6 12 and 24 36 48 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine and compare between above 2 groups
• Intra operative opioid consumption
• Time to rescue analgesia in post operative period (in hours)
• Parental satisfaction score
• Stress response measured by taking baseline and 24 hrs salivary cortisol levels
• Occurrence of bladder spasm post operatively in the first 24 hours postoperatively
• Time to achieving DrEaMing bundle (Drinking, eating and mobilising bundle) |
Upto 24hours |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/10/2026 |
| 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="2"
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
|
Analgesic efficacy of ultrasound guided Sacral Erector Spinae Plane Block versus Caudal epidural Block in pediatric patients undergoing urethroplasty under general anesthesia: a randomized controlled study is my study title. Aim of our study is to compare the analgesic efficacy of ultrasound guided sacral erector spinae plane block versus caudal epidural block in pediatric patients undergoing urethroplasty under general anesthesia. Primary objective is to determine and compare effect on intra and post-operative analgesia over the 1st 24 hrs after surgery. A total sample size of 60 patients with age group 1-8yrs will be recruited in the study and divided into two groups one with ultrasound guided sacral Erector Spinae Plane Block and the other with ultrasound guided caudal block each group consisting of 30 patients. Erector Spinae Plane Block group patient will be positioned in the lateral position for block. Under all aseptic precautions, USG guided (7–13 MHz linear probe on the Sonosite™ MTurbo) erector spinae plane block will be given with echogenic 5 cm 22 G needle at the 3rd - 4th median crest with 0.25% bupivacaine (1ml/kg) combined with dexmedetomidine 1mcg/kg after negative aspiration. In caudal epidural block group patient will be positioned in the lateral position for the caudal block. Under all aseptic precautions USG guided caudal epidural block will be given using 0.25% bupivacaine 1 ml/kg volume with dexmedetomidine 1mcg/kg. FLACC (face, legs, activity, cry, consolability) scale score at different time points- 0 h, 1 h, 2, 6, 12 and 24, 36, 48 h postoperatively. Will determine and compare intra operative opioid consumption , time to rescue analgesia in post operative period (in hours) , Parental satisfaction score, Stress response measured by taking baseline and 24 hrs salivary cortisol levels, Occurrence of bladder spasm post operatively in the first 24 hours postoperatively , Time to achieving DrEaMing bundle (Drinking, eating and mobilising bundle). |