| CTRI Number |
CTRI/2025/09/094973 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare different concentrations and volumes of bupivacaine for open inguinal hernia surgery in children |
|
Scientific Title of Study
|
Comparison of Post Operative Analgesic Efficacy of Quadratus Lumborum Block With Bupivacaine of Same Dose and Different Concentrations in Paediatric Patients Undergoing Unilateral Open Inguinal Hernia Repair |
| 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 Mayank Singh |
| Designation |
PG Resident |
| Affiliation |
VMMC and Safdarjung Hopital |
| Address |
Department of Anaesthesia and Intensive care , Vardhman Mahavir medical college and Safdarjung Hospital, Ansari Nagar West, New Delhi,
South West
DELHI
110029
India |
| Phone |
7023799729 |
| Fax |
|
| Email |
mayank07singh007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arushi Gupta |
| Designation |
Professor |
| Affiliation |
VMMC and Safdarjung Hopital |
| Address |
Department of Anaesthesia and Intensive care , Vardhman Mahavir medical college and Safdarjung Hospital, Ansari Nagar West, New Delhi,
South West
DELHI
110029
India |
| Phone |
8800660246 |
| Fax |
|
| Email |
drarushigupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arushi Gupta |
| Designation |
Professor |
| Affiliation |
VMMC and Safdarjung Hopital |
| Address |
Department of Anaesthesia and Intensive care , Vardhman Mahavir medical college and Safdarjung Hospital, Ansari Nagar West, New Delhi,
South West
DELHI
110029
India |
| Phone |
8800660246 |
| Fax |
|
| Email |
drarushigupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital ,Ansari Nagar East , New Delhi , Pincode- 110029 |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
VMMC and Safdarjung Hospital ,Ansari Nagar East , New Delhi , Pincode- 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 Mayank Singh |
First floor, Main OT building , Safdarjung Hospital |
Department of Anaesthesia and Intensive care , Vardhman Mahavir medical college and Safdarjung Hospital, Ansari Nagar West, New Delhi,
South West
DELHI |
7023799729
mayank07singh007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, VMMC and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound guided Quadratus lumborum block with 0.3ml/kg of 0.25% bupivacaine |
Ultrasound-guided Quadratus Lumborum block will be administered after induction of anesthesia using 0.3 ml/kg of 0.25% bupivacaine (single-shot). The route of administration will be peripheral nerve block under ultrasound guidance. Only a single dose will be given, with no repeat dosing planned. The expected duration of analgesic effect is approximately 12–18 hours postoperatively, depending on patient response.
|
| Intervention |
Ultrasound guided Quadratus lumborum block with 0.6ml/kg of 0.125% bupivacaine |
Ultrasound-guided Quadratus Lumborum block will be administered after induction of anesthesia using 0.6 ml/kg of 0.125% bupivacaine (single-shot). The route of administration will be peripheral nerve block under ultrasound guidance. Only a single dose will be given, with no repeat dosing planned. The expected duration of analgesic effect is approximately 12–18 hours postoperatively, depending on patient response. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 1 – 7 years with American Society of Anesthesiologists physical status
I-II scheduled for unilateral open inguinal hernia surgery. |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
1. Infection at the site of block
2. Coagulopathy
3. Pre-existing neurological disease
4. Allergy to local anesthetics |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare post operative analgesic efficacy of Quadratus lumborum block with bupivacaine
of same dose and different concentrations in paediatric patients undergoing open inguinal
hernia repair using the CHEOPS score at 6 hours. |
CHEOPS score at 6 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare CHEOPS score at 0,3,8,18 and 24 hours.
2.To compare time to first rescue analgesia
3.To compare Total doses of analgesics over 24 hours duration .
4.To evaluate intraoperative fentanyl requirement |
CHEOPS score at 0,3,8,18 and 24 hours post operative. |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="6"
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
|
This study is a prospective, interventional trial designed to assess the effectiveness of ultrasound-guided Quadratus Lumborum Block (QLB) for postoperative pain relief in children aged 1 to 7 years undergoing unilateral open inguinal hernia surgery. The research compares two groups receiving the same total dose of bupivacaine (0.75 mg/kg) but at different concentrations and volumes: Group A receives 0.3 ml/kg of 0.25% bupivacaine, while Group B receives 0.6 ml/kg of 0.125% bupivacaine. The primary outcome is pain score measured using the CHEOPS scale at 6 hours post-surgery. Secondary outcomes include pain scores at additional time intervals, time to first rescue analgesia, total analgesic consumption over 24 hours, and intraoperative fentanyl usage. The goal is to determine whether a lower concentration with higher volume offers pain relief comparable to a higher concentration with lower volume, while remaining within safe limits for pediatric patients. |