| CTRI Number |
CTRI/2025/06/089607 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two interfascial regional nerve blocks for post-operative pain relief |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of ultrasound-guided Quadratus Lumborum block versus Erector Spinae plane block in children undergoing elective laparoscopic pyeloplasty – A randomized, double-blinded, 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 Atul Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
IMS, BHU |
| Address |
Department of Anaesthesiology, IMS, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8317010317 |
| Fax |
|
| Email |
atulksingh84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
IMS, BHU |
| Address |
Department of Anaesthesiology, IMS, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8317010317 |
| Fax |
|
| Email |
atulksingh84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
IMS, BHU |
| Address |
Department of Anaesthesiology, IMS, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8317010317 |
| Fax |
|
| Email |
atulksingh84@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sir Sunderlal Hospital, IMS, BHU |
| Address |
IMS, BHU, Varanasi, Pin 221005 |
| 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 Atul Kumar Singh |
Sir Sunderlal Hospital, BHU, Varanasi |
Department of Anaesthesiology, IMS, BHU, Varanasi, Pin 221005
Varanasi
UTTAR PRADESH |
8317010317
atulksingh84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IMS, BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erector Spinae plane Block |
Ultrasound guided Erector Spinae plane Block
Group E: receiving the ESP block at T10 level under all aseptic precautions placing patients in a lateral position (side to be blocked upward) with 0.5 ml/kg of 0.2% ropivacaine. |
| Intervention |
Quadratus Lumborum Block |
Ultrasound guided block : Quadratus Lumborum Block
Group Q: receiving anterior QL block under all aseptic precautions in a lateral position (side to be blocked upward) with 0.5 ml/kg of 0.2% ropivacaine.
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group between 2 -15 years of either sex
2) Patients having Pelviureteric junction obstruction
3) Patients belonging to American Society of Anaesthesiologists physical status I and II |
|
| ExclusionCriteria |
| Details |
1) Parent/legal guardian refusal.
2) Age less than 2 years or more than 15 years
3) Children with, coagulopathy/sepsis.
4) Obesity(body mass index more than 30 kg per square metre)
5) Those who were converted to open
6) Those who couldn’t be extubated at end of surgery
7) Major intraoperative adverse events
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of post operative analgesia over the first 24 hours after ultrasound-guided Quadratus Lumborum block versus Erector Spinae plane block |
MOPS score at 0,1,2,3, 4,8,12,16, 20, 24 hours after the completion of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MOPS score |
2, 4,8,12, 24 and 48 hrs |
| Need of rescue analgesia in no. of dosage (Tramadol 1.5 mg/kg) in the postoperative period. |
|
| Motor weakness |
|
| Parent satisfaction scale under 4-point Likert scale |
|
| Time to discharge |
|
|
|
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)
|
10/07/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
AIM: To compare the analgesic efficacy of ultrasound-guided Quadratus Lumborum block versus Erector Spinae plane block in children undergoing elective laparoscopic pyeloplasty Methods: Study will be conducted after ethical approval in paediatric patients (age 2-15 year) of either sex belonging to ASA 1 or 2 class undergoing laparoscopic pyeloplasty for pelviuretric junction obstruction. Patients (total 100) will be randomly assigned into two groups: 1) Group Q: receiving anterior QL block under all aseptic precautions in a lateral position (side to be blocked upward) with 0.5 ml/kg of 0.2% ropivacaine. 2) Group E: receiving the ESP block at T10 level under all aseptic precautions placing patients in a lateral position (side to be blocked upward) with 0.5 ml/kg of 0.2% ropivacaine. Postoperative pain will be assessed at specified intervals using the Modified Objective Pain Score (MOPS). Total number of rescue analgesia given (Inj Tramadol 1.5 mg/kg) will be noted. Any side effects like motor block, nausea, vomiting and urinary retention will also be noted. Objectives: Primary- MOPS score at 12 hours Secondary- 1. MOPS score at 2, 4,8,12, 24 and 48 hrs 2. Need of rescue analgesia in no. of dosage (Tramadol 1.5 mg/kg) in the postoperative period. 3. Motor weakness 4. Parent satisfaction scale under 4-point Likert scale 5. Time to discharge Study Period: 1 year |