CTRI Number |
CTRI/2025/04/085561 [Registered on: 24/04/2025] Trial Registered Prospectively |
Last Modified On: |
21/04/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Easing Postoperative Pain in Children: Comparing Two Nerve Block Techniques After Hernia Surgery |
Scientific Title of Study
|
Comparative evaluation of postoperative analgesia between ultrasound guided lumbar erector spinae plane block and ilioinguinal-iliohypogastric block in children undergoing inguinal hernia surgeries: A Randomised Controlled trial |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Lavanya S |
Designation |
Fellow in Paediatric Anesthesia |
Affiliation |
Chacha Nehru Bal Chikitsalaya |
Address |
Department of Anaesthesia
Chacha Nehru Bal Chikitsalaya
Raja Ram Kohli Marg
Geeta Colony
New Delhi DELHI 110031 India |
Phone |
9944573104 |
Fax |
|
Email |
lavanyasundaram20@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Geeta Kamal |
Designation |
Senior specialist |
Affiliation |
Chacha Nehru Bal Chikitsalaya |
Address |
Department of Anaesthesia
Chacha Nehru Bal Chikitsalaya
Raja Ram Kohli Marg
Geeta Colony
New Delhi DELHI 110031 India |
Phone |
9643308229 |
Fax |
|
Email |
kmlgeeta@rediff.com |
|
Details of Contact Person Public Query
|
Name |
Geeta Kamal |
Designation |
Senior specialist |
Affiliation |
Chacha Nehru Bal Chikitsalaya |
Address |
Department of Anaesthesia
Chacha Nehru Bal Chikitsalaya
Raja Ram Kohli Marg
Geeta Colony
New Delhi DELHI 110031 India |
Phone |
9643308229 |
Fax |
|
Email |
kmlgeeta@rediff.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Chacha Nehru Bal Chikitsalaya |
Address |
Raja Ram Kohli Marg
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 Lavanya S |
Chacha Nehru Bal Chikitsalaya |
Department of Anaesthesia
Raja Ram Kohli Marg
Geeta Colony
New Delhi 110031 New Delhi DELHI |
9944573104
lavanyasundaram20@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 |
Intervention |
Ilioinguinal- iliohypogastric nerve block |
This is ultrasound guided peripheral nerve block with 0.5ml/kg of 0.25% bupivacaine and 0.5mcg/kg of dexmedetomidine given only once before surgery. |
Intervention |
Lumbar erector spinae plane block |
This is ultrasound guided peripheral nerve block with 0.5ml/kg of 0.25% bupivacaine and 0.5mcg/kg of dexmedetomidine given only once before surgery. |
|
Inclusion Criteria
|
Age From |
3.00 Year(s) |
Age To |
8.00 Year(s) |
Gender |
Both |
Details |
Age 3 to 8 years
ASA physical status I and II
Posted for elective inguinal hernia surgeries under general anaesthesia |
|
ExclusionCriteria |
Details |
• History of developmental delay/ mental retardation
• Patients undergoing laparoscopic herniotomy/ bilateral open herniotomy
• Anomalies of spine and central nervous system
• History of allergy to drugs used in study.
• History of bleeding disorders
• Infection at injection site
• Parent refusal to the procedure
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Time to requirement of first rescue analgesia in the postoperative period |
From the time of administration of the nerve block till the requirement of postoperative analgesia |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the incidence of complications like hypotension, bradycardia, nausea and vomiting, apnea, desaturation
Postoperative sedation scores |
Till 24hours postoperative |
|
Target Sample Size
|
Total Sample Size="58" Sample Size from India="58"
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)
|
02/05/2025 |
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 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
|
Inguinal hernia surgery is a daycare procedure. Paediatric patients who are undergoing inguinal hernia surgeries experience pain intraoperatively and postoperatively which persists as a chronic pain. Caudal analgesia was the preferred regional technique till date. However this technique has its own limitations like short duration of action and complications because of the drug administration in the epidural space. To overcome these we are comparing ultrasound guided Erector spinae plane block and ilioinguinal-iliohypogastric nerve block which are plane blocks. They are simple effective and with less complications. The postoperative anlagesia will be evaluated using Wong bakers faces pain rating scale and postoperative sedation will be evaluated using Ramsay sedation score. ASA I and II patients of age 3 to 8 years are included in the study who are undergoing inguinal hernia surgery on an elective basis. The primary outcome will be to evaluate the time to first rescue analgesia between two groups in the postoperative period. The secondary outcome is to compare the incidence of the complications like apnea, desaturation and hypotension. The study will be conducted for a period of 1 year. Sample size was calculated by assuming mean difference in time to first rescue analgesia between ilioinguinal iliohypogastric nerve block group and Erector spinae plane block group as 250 mins as per El.Emam Em et al. The required sample size will be 26 per group approximately. Considering drop out ratio of 10% 3 patients added to each group making approximately 29 in each group.
|