| CTRI Number |
CTRI/2018/01/011445 [Registered on: 19/01/2018] Trial Registered Prospectively |
| Last Modified On: |
19/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of anterior abdominal wall blocks in open pyeloplasty in children |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of ultrasound guided quadratus lumborum block versus transversus abdominis plane block for pyeloplasty for children- a randomized, double blind, controlled trial. |
| Trial Acronym |
QL Vs TAP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Praveen Talawar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No-5011
Department of Anaesthesiology, Pain Medicine and Critical Care
5th floor, Teaching block
AIIMS, Ansari Nagar
New Delhi
110029
Room No 5011
5th Floor
Teaching Block
AIIMS
New Delhi
110029
South
DELHI
110049
India |
| Phone |
9654162941 |
| Fax |
|
| Email |
praveenrt64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Talawar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
FTA-507
5th floor
AV Nagar
New Delhi
Room No 5011
5th Floor
Teaching Block
AIIMS
New Delhi
110029
South
DELHI
110049
India |
| Phone |
9654162941 |
| Fax |
|
| Email |
praveenrt64@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Talawar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
FTA-507
5th floor
AV Nagar
New Delhi
Room No 5011
5th Floor
Teaching Block
AIIMS
New Delhi
110029
South
DELHI
110049
India |
| Phone |
9654162941 |
| Fax |
|
| Email |
praveenrt64@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Pain Medicine and Critical Care
All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Room No-5011, 5th floor
Teaching Block
Department of Anaesthesiology, Pain Medicine and Critical care
AIIMS, New Delhi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Praveen Talawar |
AIIMS New Delhi |
Room No-5011
5th Floor
Teaching Block
Department of Anaesthesiology Pain Medicine and Critical Care
AIIMS New Deli
South
DELHI |
09654162941
9654162941
praveenrt64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Children undergoing pyeloplasty aged between 2 to 10 years age group, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound Guided Abdominal wall blocks |
0.5ml/kg of Ropivacaine 0.375% |
| Comparator Agent |
Ultrasound Guided Quadratus lumborum block (Trans-muscular approach) |
Patient will be lateral position, with the block to be given up. A linear probe will be placed between iliac crest and costal margin to identify the transverse process of lumbar vertebre, the muscle superficial to the transverse process is erector spinae, the muscle deep to the transverse process is quadratus lumborum, which seperates from psoas major muscle lying anterolateral to the vertebral body
The needle is passed in line, and placement of needle in between the quadratus lumborum and psoas major muscle is confirmed by hydrodissection using 2-3 ml of normal saline. The drug solution is injected once confirming the needle placement |
| Comparator Agent |
Ultrasound Guided Transversus Abdominis Plane (TAP) Block |
Under High frequency ultrasound probe, the three layers of the abdominal wall are identified on the side to be blocked. The drug solutions are injected when hydodissection with 2-3ml of normal saline confirms the needle placement between the internal oblique and transversus abdominis using in line technique |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiology physical status I and II
Posted for elective pyeloplasty |
|
| ExclusionCriteria |
| Details |
1. Refusal of parents or guardians to participate in the study
2. Developmental delay and mental retardation
3. History of sensitivity to drugs used in the study
4. Coagulopathy
5. Infection at the puncture site
6. Significant cardiac renal or liver disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome
To compare the intraoperative and post operative analgesic consumptions and post operative VAS scores
Secondary Objectives
To compare the incidence of nausea or vomiting, excessive sedation and respiratory depression |
at 1, 2, 4, 6, 8, 12, 18, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Objectives
To compare the incidence of nausea or vomiting, excessive sedation and respiratory depression |
At 1, 2, 4, 6, 8, 12, 18 and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/02/2018 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
References
1. D.M. El-Fawy, H.A. El-Gendy. Ultrasound-guided transversus abdominis plane block versus caudal block for postoperative pain relief in infants and children undergoing surgical pyeloplasty. Ain-Shams J Anesthesiology, 07 (2014), pp. 177–181.
2. Chakraborty A, Goswami J, Patro V. Ultrasound-guided continuous quadratus lumborum block for postoperative analgesia in a pediatric patient. Case Rep. 2015 Feb 1;4(3):34–6.
3. Visoiu M, Yakovleva N. Continuous postoperative analgesia via quadratus lumborum block - an alternative to transversus abdominis plane block. Paediatr Anaesth. 2013 Oct;23(10):959–61.
4. Baidya DK, Maitra S, Arora MK, Agarwal A. Quadratus lumborum block: an effective method of perioperative analgesia in children undergoing pyeloplasty. J Clin Anesth. 2015 Jul 11;
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Renal surgeries are commonly performed procedures in children and are associated with significant post-operative pain. Effective postoperative analgesia is essential to allow coughing, early mobilization, and to reduce the incidence of post-operative respiratory complications. Compared to systemic opioids , neuraxial analgesia and peripheral nerve blockade techniques can provide superior analgesia while avoiding majority of side effects of opioids as well as NSAIDs. The transversus abdominis plane (TAP) block and quadratus lumborum(QL) block are the truncal nerve blocks that targets the lower thoracic and upper lumbar nerves as they course through the inter-fascial planes and provides analgesia for procedures involving the abdominal wall.
Quadratus lumborum (QL) block is a newly introduced variation of TAP block, reported to provide excellent post-operative analgesia in; pediatric patients undergoing radical nephrectomy (2), colostomy closure (3), pyeloplasty .
|