| 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 |
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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] |
|
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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 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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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 |
|
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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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