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CTRI Number  CTRI/2025/07/090901 [Registered on: 15/07/2025] Trial Registered Prospectively
Last Modified On: 24/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Procedure to reduce pain after laparoscopic abdominal surgeries in children 
Scientific Title of Study   A study to compare Lateral quadratus lumborum block versus Transversus abdominis plane block in paediatric patients undergoing laparoscopic surgeries A Randomised control 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  DR SHREYA S HEGDE 
Designation  Post graduate student 
Affiliation  Bangalore Medical College and Research Institute 
Address  3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, Fort road, Near City market, Bengaluru

Bangalore
KARNATAKA
560002
India 
Phone  8197264790  
Fax    
Email  shreyahegde19@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Saraswathi N  
Designation  Associate Professor 
Affiliation  Bangalore Medical College and Research Institute 
Address  3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, Fort road, Near City market Bengaluru

Bangalore
KARNATAKA
560002
India 
Phone  9663304834  
Fax    
Email  dr.saraswathi.pmssy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Saraswathi N  
Designation  Associate Professor 
Affiliation  Bangalore Medical College and Research Institute 
Address  3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, Fort road, Near City market Bengaluru

Bangalore
KARNATAKA
560002
India 
Phone  9663304834  
Fax    
Email  dr.saraswathi.pmssy@gmail.com  
 
Source of Monetary or Material Support  
3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, Fort road, Near City market, Bengaluru Bangalore KARNATAKA 560002 India  
 
Primary Sponsor  
Name  DrShreya S Hegde 
Address  3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, Fort road, Near City market, Bengaluru KARNATAKA 560002 India  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shreya S Hegde  Bangalore Medical College and Research Institute  5th floor, Department of Anaesthesiology, Bangalore Medical College and Research Institute-Super Speciality Hospital, Fort road, Near City market, Bengaluru
Bangalore
KARNATAKA 
8197264790

shreyahegde19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore Medical College and Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lateral quadratus lumborum block  For the ultrasound guided QLB group, the patient will be placed in supine position, and skin sterilizations will be performed with antiseptic solution and draped. A high-frequency linear probe will then be placed above the iliac crest in the area of triangle of petit, to identify three layers- 3 abdomen barrier muscles. First, transverse abdominis will be outlined posteriorly till the transverse aponeurosis appears, then the probe can be sloped a little caudal to improve transverse aponeurosis appears. Next, QL will be recognized medial to the aponeurosis of transverse abdominal muscles. The 20G needle will then be injected from superofrontal to posteroinferior and progressive via the inplane method till the needle tip touches the anterolateral edge of the QL at its junction with the transversalis fascia. After negative aspirations (to reject intravascular injections), 1 mL of normal saline will be injected to confirm the position of the needle. After confirming the position of the needle, a bolus dose of 0.125% bupivacaine 0.5ml/kg will be injected. The same method will be performed on the other side also. On ultrasound, the distribution of local anaesthetic agent will be observed as a hypo-echoic enlargement beneath transversus abdominis aponeurosis. 
Comparator Agent  Transversus abdominis plane block  For posterior approach TAP block, patients will be placed in supine position, the anterolateral abdominal wall on both sides will be prepared with antiseptic solution and draped. Ultrasound probe will be placed in flank region between anterior superior iliac spine and costal margin. The External Oblique, Internal Oblique and Transversus abdominis identified, among which internal oblique is the most prominent layer. The 20 gauge intravenous cannula will be advanced in the plane in anterior direction. After placement of the cannula between Internal Oblique and Transversus abdominus, 1ml of normal saline will be injected to confirm the placement of needle. After confirming the position of the needle, a bolus dose of Inj 0.125% bupivacaine 0.5ml/kg will be injected on both sides. On ultrasound, the distribution of local anaesthetic agent will be observed as a hypo-echoic enlargement between the fascial planes as a real time image. 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1. Parents of paediatric patients willing to give informed consent
2. Patients of age 7-14 years.
3. ASA grade 1 & 2
4. Paediatric patients undergoing laparoscopic surgeries
 
 
ExclusionCriteria 
Details  1. Patients with history of coagulopathy
2. Patients with history of allergy to local anaesthetic
3. Patients with severe systemic diseases
4. Psychiatric illness
5. Chronic medication for pain
6. Patient requiring postoperative mechanical ventilation
7. Local infection over injection site
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the postoperative analgesic duration of lateral quadratus lumborum block and posterior transversus abdominis plane block for laparoscopic surgeries in paediatric patients  15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the frequency and number of doses of rescue analgesia required   fifteen minutes, thirty minutes, sixty minutes, two hours, four hours, eight hours, twelve hours, twenty four hours post operatively.  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   26/07/2025 
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="6"
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  

Patients will be allocated into two groups using computer generated numbers. Each group will be comprised of 40 patients. The primary investigator of the study will be blinded to the treatment.

 Group 1- Lateral Quadratus lumborum block.

 Group 2-Posterior Transversus Abdominis Plane block.

Routine pre-anaesthetic evaluation will be done and the patients will be kept nil per oral for 6 hours prior to surgery. On arrival at operation theatre standard anesthesia monitors including non-invasive blood pressure (NIBP) , electrocardiogram (ECG) and pulse oximetry will be attached and baseline hemodynamic parameters will be noted.

For the ultrasound guided QLB group, the patient will be placed in supine position, and skin sterilizations will be performed with antiseptic solution and draped. A high-frequency linear probe will then be placed above the iliac crest in the area of triangle of petit, to identify three layers- 3 abdomen barrier muscles. First, transverse abdominis will be outlined posteriorly till the transverse aponeurosis appears.  Next, QL will be recognized medial to the aponeurosis of transverse abdominal muscles. The 20G needle will then be injected from superofrontal to posteroinferior and progressive via the inplane method till the needle tip touches the anterolateral edge of the QL at its junction with the transversalis fascia. After negative aspirations (to reject intravascular injections), 1 mL of normal saline will be injected to confirm the position of the needle. After confirming the position of the needle, a bolus dose of 0.125% bupivacaine 0.5ml/kg will be injected. The same method will be performed on the other side also. On ultrasound, the distribution of local anaesthetic agent will be observed as a hypo-echoic enlargement beneath transversus abdominis aponeurosis.

For posterior approach TAP block, patients will be placed in supine position, the anterolateral abdominal wall on both sides will be prepared with antiseptic solution and draped. Ultrasound probe will be placed in flank region between anterior superior iliac spine and costal margin. The External Oblique, Internal Oblique and Transversus abdominis identified.  The 20 gauge intravenous cannula will be advanced in the plane in anterior direction. After placement of the cannula between Internal Oblique and Transversus abdominus, 1ml of normal saline will be injected to confirm the placement of needle. After confirming the position of the needle, a bolus dose of Inj 0.125% bupivacaine 0.5ml/kg will be injected on both sides. On ultrasound, the distribution of local anaesthetic agent will be observed as a hypo-echoic enlargement between the fascial planes as a real time image.

 After performing the respective blocks, inhalational agent will be discontinued. Extubation will be done after complete recovery assessed by clinical observation and neuromuscular monitoring. Reversal of neuromuscular blocking agent will be done with Inj.Neostigmine 0.5mg/kg and  Inj.Glycopyrrolate 10 mcg/kg.

 Haemodynamic parameters like heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, SPO2 will be recorded in fifteen minutes, thirty minutes, sixty minutes, two hours, four hours, eight hours, twelve hours, twenty four hours post operatively. Pain will be assessed using MOPS scale, with zero representing no pain and ten representing worst pain. Patients receive Inj. Tramadol 1mg/kg IV as rescue analgesic.

 Patients will be assessed for time to first rescue analgesia as the time interval between the end of block performance and first demand by patient for rescue analgesia. The total amount of rescue analgesia is described as total dose of Tramadol (1mg/kg) required in 24 hours since the end of block performance. Side effects if any will be recorded.


 
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