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CTRI Number  CTRI/2024/10/074599 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 17/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   The Effect of quadratus lumborum block for controlling pain in childrens undergoing renal transplant surgery 
Scientific Title of Study   The effect of posterior quadratus lumborum block for intra and post operative analgesia in pediatric patients undergoing renal transplant surgery-a pilot 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. RATISH C 
Designation  Junior Resident 
Affiliation  AIIMS NEW DELHI 
Address  Room NO:5014B,DEPARTMENT OF ANAESTHESIA, All India institute of Medical Sciences, Ansari Nagar, ANSARI NAGAR EAST, New Delhi

New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  ratish.c775@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR. Rashmi Ramachandran 
Designation  Professor 
Affiliation  AIIMS NEW DELHI 
Address  DEPARTMENT OF ANAESTHESIA,All India institute of Medical Sciences, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9811422188  
Fax    
Email  rashmiramachandran1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR. RATISH C 
Designation  Junior Resident 
Affiliation  AIIMS NEW DELHI 
Address  Room NO:5014B,DEPARTMENT OF ANAESTHESIA, All India institute of Medical Sciences, Ansari Nagar, ANSARI NAGAR EAST, New Delhi

New Delhi
DELHI
110029
India 
Phone  9811422188  
Fax    
Email  ratish.c775@gmail.com  
 
Source of Monetary or Material Support  
Room NO:5014B,DEPARTMENT OF ANAESTHESIA, All India institute of Medical Sciences, Ansari Nagar, ANSARI NAGAR EAST, New Delhi 
 
Primary Sponsor  
Name  Ratish 
Address  Room NO:5014B,DEPARTMENT OF ANAESTHESIA, All India institute of Medical Sciences, Ansari Nagar, ANSARI NAGAR EAST, New Delhi 
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 Rashmi Ramachandran  ALL INDIA INSTITUTE OF MEDICAL SCIENCES  Department of Anaesthesia,All India Institute of Medical Science New Delhi,Delhi-110029
New Delhi
DELHI 
9811422188

rashmiramachandran1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Commitee-Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N185||Chronic kidney disease, stage 5, (2) ICD-10 Condition: N261||Atrophy of kidney (terminal), (3) ICD-10 Condition: N189||Chronic kidney disease, unspecified, (4) ICD-10 Condition: N19||Unspecified kidney failure, (5) ICD-10 Condition: N258||Other disorders resulting from impaired renal tubular function,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  0.5ml Normal saline injected posterior to QL muscle once before surgery 
Intervention  Quadratus Lumborum block  0.5ml/kg of 0.2% Ropivacaine through posterior part of QL muscle given once before start of surgery 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1.Age between 7 and 18 years Undergoing Renal transplant
2.Both genders 
 
ExclusionCriteria 
Details  1.Non consenting Patient or parent
2.Coagulation disorder
3.Allergy to Local Anaesthetics
4.Pre Existing Peripheral neuropathies
5.Failed tracheal extubation 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Alternation 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Time to first requirement of analgesia after tracheal extubation  1st, 2nd ,4th ,6th,12th and 24th hour after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
1.NRS at 1st,2nd,4th,6th,12th and 24th hour postoperatively

2.The total fentanyl consumption throughout postoperative 24 hours

3.Postoperative side effects in the form of hypotension, bradycardia, nausea and vomiting for 24 hours after surgery

4.Patient and parent satisfaction score with analgesia
 
24 hours 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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/ Phase 3 
Date of First Enrollment (India)   15/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/10/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
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  

Main purpose of quadratus lumborum block is to provide adequate analgesia for pediatric patients. The utility of QLB has been shown in adults undergoing renal transplant surgery. Children with CKD would understandably be at a disadvantage when undergoing surgery. The fear of opioid overdose, greater risk with neuraxial blockade and inability to use NSAIDS places them at a disadvantage when it comes to adequate perioperative analgesia. This study aims to explore the analgesic efficacy of posterior QLB in children undergoing renal transplant surgery.

Pre-operative evaluation

Detailed PAC

Informed written parental consent.

 Investigations: Serum sodium, potassium, calcium, complete blood count, blood urea, serum creatinine and chest x ray.

 

Intra operative care

Patients will be randomized into 2 groups (Standard and Quadratus lumborum block group)

ASA standard monitors like pulse oximeter, NIBP, electrocardiography will be attached and baseline values of pulse rate, SpO2, blood pressure, ECG will be recorded.

Anaesthesia will be induced after securing IV cannula.

 Intravenous isotonic fluid (Ringer’s Lactate) will be started.

Intravenous etomidate in the dose of 0.3-0.4 mg/kg or propofol 2-3 mg/kg along with fentanyl in the dose of 2-3 mcg/kg will be used for induction of anesthesia. Muscle relaxants, atracurium 0.5 mg/kg, will be injected and patient will be intubated with appropriate sized endotracheal tube

Quadratus lumborum block will be given as per group allocation before surgical incision.

 A linear multi-frequency 6-13 MHz transducer probe wrapped with a sterilized sheath will be utilized for ultrasound guided QLB.

The child will be positioned in a lateral position with operative side up. The probe will be placed above the iliac crest where external, internal oblique, and transversus abdominis muscles could be seen; the probe will be then advanced posteriorly till the quadratus lumborum (QL) muscle is seen deep within the latissimus dorsi. After that, a 22-gauge, 60 mm length Sono Plex echogenic needle will be advanced in-plane from an anterior to posterior direction until the needle tip is positioned between the posterior border of QL and its fascia. 0.5ml-1ml saline will be injected to confirm the needle tip’s position. This will be followed by injection of 0.5ml/kg of 0.2% ropivacaine after negative aspiration rules out intravascular placement.

Proper placement should result in spread of local anesthetic through the middle TLF layer and into the interfascial triangle. Surgery will be allowed to start once the patient is turned to supine position and all the monitors are in place and the baseline values have been taken. Intraoperatively, whenever the hemodynamics suggest analgesic requirement, fentanyl 1mcg/kg will be given intravenously. All patients will receive injection paracetamol 15mg/kg.

 

 

Post operative care

After completion of surgery, patient will be extubated and shifted to Transplant Intensive Care Unit (TICU)

An anesthesiologist blinded to group allocation will monitor the children in the postoperative ward for analgesic efficacy with NRS score.

  At the first request of analgesia or if NRS ³4 patients will be given fentanyl 1mcg/kg and an infusion of fentanyl will be started at 0.25-1mcg/kg/hr to maintain NRS <4.

 



 
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