| CTRI Number |
CTRI/2022/04/041876 [Registered on: 13/04/2022] Trial Registered Prospectively |
| Last Modified On: |
12/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare two different blocks in for pain management in children undergoing kidney surgeries. |
|
Scientific Title of Study
|
A comparative study on perioperative analgesic efficacy of Ultrasound guided Erector Spinae Plane block and Posterior Transversus Abdominis Plane block in Pediatric patients undergoing Renal surgery :A Prospective Randomized trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Seema Naib |
| Designation |
Junior resident |
| Affiliation |
Post Graduate institute of medical education and research |
| Address |
Department of Anaesthesia, 4th floor B block, Nehru Hospital, PGIMER
Department of Anaesthesia, 4th floor B block, Nehru Hospital, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9501104984 |
| Fax |
|
| Email |
drseemapgimer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anudeep Jafra |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate institute of medical education and research |
| Address |
department of anaesthesia 4th floor B block Nehru hospital, post Graduate Institute of Medical Education and Research
department of anaesthesia 4th floor B block Nehru hospital, post Graduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888027699 |
| Fax |
|
| Email |
anu_gmch@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Naib |
| Designation |
Junior resident |
| Affiliation |
Post Graduate institute of medical education and research |
| Address |
department of anaesthesia 4th floor B block Nehru hospital, post Graduate Institute of Medical Education and Research
department of anaesthesia 4th floor B block Nehru hospital, post Graduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9501104984 |
| Fax |
|
| Email |
drseemapgimer@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
Post Graduate Institute of Medical education and research, sector 12, 160012, Chandigarh |
| 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 Seema Naib |
Post Graduate Institute of Medical Education and Research, Sector 12, 160012 |
operation theatre of Advanced pediatric center, 6th floor, PGIMER
Chandigarh
CHANDIGARH |
9501104984
drseemapgimer@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: O||Medical and Surgical, (2) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
erector spinae plane block |
patients will receive block after induction of anaesthesia with 0.4ml/kg of 0.2% ropivacaine with 1mcg/kg of dexmedetomidine, single shot. drug will be deposited between erector spinae muscle and tranversus process at T 9 vertebral level. patient will be monitored for 24 hours. |
| Comparator Agent |
posterior transversus abdominis plane block |
patients will receive block after induction of anaesthesia with 0.4ml/kg of 0.2% ropivacaine with 1mcg/kg of dexmedetomidine, single shot in transversus abdominis plane block. patient will be monitored for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II
elective total/partial nephrectomy/ pyeloplasty
|
|
| ExclusionCriteria |
| Details |
H/o Allergy to drugs used in the study.
Presence of a congenital heart disease
Presence of cardiac/ respiratory/renal or hepatic dysfunction
ASA III and IV
Local Infection
Coagulopathy |
|
|
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 |
| Total Analgesic consumption(Acetaminophen) |
at 24 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FLACC score, WATCHA score, time to first rescue, complications |
0,15mins, 30mins, 1,2,4,6,8,12 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)
|
18/04/2022 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
posterior transversus abdominis plane block would be compared with erector spinae plane block in children undergoing total/partial nephrectomy and pyeloplasty surgery. Aim of the study is to compare the analgesic efficacy of two blocks. primary outcome would be total analgesic consumption (acetaminophen) at 24 hours and secondary outcomes include effect on perioperative hemodynamics, intraoperative fentanyl consumption, time to first analgesic consumption, FLACC pain score , behavioural score and complications. |