| CTRI Number |
CTRI/2020/01/022653 [Registered on: 08/01/2020] Trial Registered Prospectively |
| Last Modified On: |
31/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A STUDY COMPARING TWO TECHNIQUES USED FOR PAIN RELIEF DURING AND AFTER PAEDIATRIC LAPAROSCOPIC SURGERIES. |
|
Scientific Title of Study
|
A Prospective Randomised Study Comparing Erector
Spinae Plane Block with Caudal Block For Intra and Postoperative Analgesia in Pediatric Laparoscopic Surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ANANT ATKAR |
| Designation |
Fellow In Pediatric Anaesthesia |
| Affiliation |
rainbow childrens hospital , hyderabad , telangana |
| Address |
Rainbow Children Hospital Department Of Anaesthesia 4th Floor road no 2 Banjara hills HYDERABAD TELANGANA
Hyderabad
TELANGANA
500034
India |
| Phone |
8380942459 |
| Fax |
|
| Email |
anantatkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M S LATHA |
| Designation |
BASIC SCIENTIST |
| Affiliation |
rainbow childrens hospital hyderabad , telangana |
| Address |
RAINBOW CHILDRENS HOSPITAL anaesthesia department 4th floor ROAD NO 2 BANJARA HILLS HYDERABAD TELANGANA
Hyderabad
TELANGANA
500034
India |
| Phone |
8380942459 |
| Fax |
|
| Email |
ethics@rainbowhospitals.in |
|
Details of Contact Person
Public Query
|
| Name |
DR ANANT ATKAR |
| Designation |
Fellow In Pediatric Anaesthesia |
| Affiliation |
rainbow childrens hospital hyderabad , telangana |
| Address |
Rainbow Children Hospital Department Of Anaesthesia 4th Floor road no 2 Banjara hills HYDERABAD TELANGANA
Hyderabad
TELANGANA
500034
India |
| Phone |
8380942459 |
| Fax |
|
| Email |
anantatkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rainbow hospital, Department of Anaesthesia,road no 1 Banjara hills ,Hyderabad . Telangana, 500034 |
|
|
Primary Sponsor
|
| Name |
Rainbow Childrens Hospital |
| Address |
Rainbow Children Hospital Department Of Anaesthesia 4th Floor road no 2 Banjara hills HYDERABAD TELANGANA |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| ANANT ATKAR |
RAINBOW CHILDRENS HOSPITAL |
Rainbow Children Hospital Department Of Anaesthesia 4th Floor road no 2 Banjara hills HYDERABAD TELANGANA
Hyderabad
TELANGANA |
8380942459
anantatkar@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: Q408||Other specified congenital malformations of upper alimentary tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
pain score at regular interval |
pain score is assessed after the surgery is completed. |
| Intervention |
pain score at regular interval |
pain score is assessed after the surgery is completed. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Informed consent from parents
ASA 1 & 2
Age group 1-6 years undergoing laparoscopic surgery
Elective surgeries |
|
| ExclusionCriteria |
| Details |
Children with hypersensitivity to study drugs
Suspected coagulopathy
Skeletal deformity
Infection at injection site
History of developmental delay / neurological diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objective is to demonstrate persistence of
analgesia for upto 6 hours. |
1 hour ,2 hour,3 hour, 4 hour, and 6 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary objective is to measure the
intraoperative hemodynamic stability and time to
first use of rescue analgesia. |
1 hour ,2 hour,3 hour, 4 hour, and 6 hour |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/01/2020 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
A prospective randomised study comparing erector
spinae plane block with caudal block for intraoperative and post
operative analgesia in pediatric laparoscopic surgeries |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A prospective randomised study comparing erector spinae plane block with caudal block for intraoperative and post operative analgesia in pediatric laparoscopic surgeries The aim of this study is to compare the analgesic effect of ESP block and Caudal block in laparoscopic surgery. OBJECTIVES: - Primary objective is to demonstrate persistence of analgesia for upto 6 hours.
- Secondary objective is to measure the intraoperative hemodynamic stability and time to first use of rescue analgesic. |