| CTRI Number |
CTRI/2019/09/021377 [Registered on: 23/09/2019] Trial Registered Prospectively |
| Last Modified On: |
18/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the effectiveness of three regional blocks for post-operative pain in children undergoing inguinal hernia repair |
|
Scientific Title of Study
|
A Comparison of Ultrasound Guided Transversus Abdominis Plane(TAP)Block, Ilioinguinal Iliohypogastric Nerve(II&IHN)Block & Quadratus Lumborum Block(QLB) For Post-operative Analgesia, In Children Undergoing Inguinal Hernia Repair, A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyadarshini Karunamourty |
| Designation |
Junior Resident(Academic) |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of of Anesthesia,
All India Institute of Medical Sciences,Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
07708986574 |
| Fax |
|
| Email |
priyaakaruna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBikram Kishore Behera |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of of Anesthesia,
All India Institute of Medical Sciences,Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884047 |
| Fax |
|
| Email |
bikrambehera007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrBikram Kishore Behera |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of of Anesthesia,
All India Institute of Medical Sciences,Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884047 |
| Fax |
|
| Email |
bikrambehera007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical SciencesBhubaneswar |
| Address |
Bhubaneswar |
| 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 Bikram Kishore Behera |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR |
4th floor,Pediatric Surgery OT,DEPARTMENT OF ANAESTHESIA , AIIMS BHUBANESWAR KHORDHA
Khordha
ORISSA |
9438884047
bikrambehera007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N40-N53||Diseases of male genital organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1.Quadratus Lumborum Block |
1. Ultrasound guided
2. Dose : 0.4mL/Kg .25% Ropivacaine
3.Block administered after induction of general anaesthesia
4. Frequency :1 |
| Intervention |
1.Transversus Abdominis Plane (TAP) Block. |
1. Ultrasound guided
2. Dose: 0.4mL/Kg 0.25% Ropivacaine
3.Block administered after induction of general anaesthesia
4. Frequency :1 |
| Intervention |
2.Ilioinguinal Iliohypogastric Nerve Block |
1. Ultrasound guided
2. Dose: 0.2mL/Kg 0.25% Ropivacaine
3.Block administered after induction of general anaesthesia
4. Frequency :1 |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II functional status |
|
| ExclusionCriteria |
| Details |
refusal to give consent
known allergy to local anesthetics
coagulopathy
infection at the injection site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time for the first demand of rescue analgesia in minutes |
Time for the first demand of rescue analgesia in minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Comparison of post operative FLACC scores. |
post operative 24 hrs |
| 2.Total cumulative Paracetamol and Fentanyl requirement in post operative period |
post operative till discharge from hospital |
| 3. Comparison of intraoperative Fentanyl requirement among the three groups |
Intraoperative |
| 4. Total duration for performance of block |
intraoperative |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
20/10/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/05/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective Randomised controlled Trial comparing three different ultrasound guided regional blocks in patients aged 2-10yrs posted for elective open inguinal hernia surgeries. Drug used for the blocks is 0.25% Ropivacaine administered after induction of General anaesthesia. The study will be conducted on 60 subjects and the time to first analgesic requirement during the postoperative period among the three groups will be compared from postoperative period till discharge from hospital. Intra operative Fentanyl requirement, Post operative FLACC scores, Duration for performing each block and total cumulative requirement of Paracetamol and Fentanyl during post operative period till discharge from hospital will be compared as secondary outcomes. |