| CTRI Number |
CTRI/2025/04/085965 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound guided Quadratus lumborum block versus caudal block for postoperative analgesia in paediatric patients undergoing unilateral lower abdominal surgeries |
|
Scientific Title of Study
|
Comparison of Analgesic Efficacy between ultrasound guided quadratus lumborum block and landmark guided caudal block in paediatric patients undergoing unilateral lower abdominal 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 Udipta Bhuyan |
| Designation |
Post Graduate Trainee Student |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care
Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup Metro 781032
Assam
Kamrup
781032
India
Kamrup
ASSAM
781032
India |
| Phone |
8402029104 |
| Fax |
|
| Email |
udipta123456@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Faiza Ahmed Talukdar |
| Designation |
Professor and Head of the department |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care
Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup Metro 781032
Assam
Kamrup
781032
India
Kamrup
ASSAM
781032
India |
| Phone |
9864031429 |
| Fax |
|
| Email |
Faizaahmedtalukdar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Udipta Bhuyan |
| Designation |
Post Graduate Trainee Student |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care
Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup Metro 781032
Assam
Kamrup
781032
India
Kamrup
ASSAM
781032
India |
| Phone |
08402029104 |
| Fax |
|
| Email |
udipta123456@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gauhati Medical College and Hospital Kamrup Metro 781032 Assam |
|
|
Primary Sponsor
|
| Name |
Dr Udipta Bhuyan |
| Address |
Departmant of Anaesthesiology and Critical Care , Gauhati Medical College and Hospital,Guwahati,Kamrup Metro,Assam |
| Type of Sponsor |
Other [SELF] |
|
|
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 Udipta Bhuyan |
Gauhati Medical College And Hospital |
Department of Anaesthesiology and Critical Care
Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup Metro 781032
Assam
Kamrup
781032
India
Kamrup
ASSAM |
08402029104
udipta123456@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Gauhati Medical College and Hospital, Guwahati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N440||Torsion of testis, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (3) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (4) ICD-10 Condition: N448||Other noninflammatory disorders ofthe testis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.Aged 1-8 years
2.ASA Grade 1 and 2
3.Scheduled for unilateral lower abdominal surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Parent of the patient not willing to give consent.
2.Allergy to the study drug
3.Infection at the site of block
4.Spinal deformity
5.Developmental delay
6.Seizure disorder
7.Disorders of coagulation
8.Cardiovascular,renal and liver diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic requirement in the first 24 hours |
Postoperative pain will be assessed by using the FLACC scale at 30mins,1,2,4,6,12 and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Duration of analgesia between the two groups
2.Pain scores between the two groups
3.Pain scores between the two groups.
4.Parent satisfaction score between the two groups
5.Complications associated with each technique. |
Postoperative pain will be assessed by using the FLACC scale at 30mins,1,2,4,6,12 and 24 hours
Complications associated with each technique will be evaluated within one hour of intervention. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/05/2025 |
| 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="0"
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
|
Paediatric patients undergoing lower abdominal surgeries often experience postoperative pain, necessitating effective analgesia to optimise recovery and discomfort.
Inadequate analgesia in the paediatric patients can cause biobehavioural changes that may modulate future responses to pain . Providing adequate analgesia is a pre-requisite for early and enhanced recovery after surgery.
Quadratus lumborum block and caudal block are regional anaesthesia techniques used to provide postoperative pain relief in this population.
Hence, this study aims to compare the analgesic requirements in the first 24 hours postoperatively between Quadratus lumborum block and caudal block in paediatric patients undergoing unilateral lower abdominal surgeries. |