| CTRI Number |
CTRI/2020/02/023184 [Registered on: 07/02/2020] Trial Registered Prospectively |
| Last Modified On: |
06/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare ropivacaine with fentanyl and bupivacaine fentanyl for caudal epidural in paediatric surgeries |
|
Scientific Title of Study
|
Comparison of ropivacaine with fentanyl and bupivacaine with fentanyl for caudal epidural in paediatric infra umbilical surgeries - A prospective randomised study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya S |
| Designation |
Post Graduate |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram India
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9003268274 |
| Fax |
|
| Email |
divyaroja1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S N Krishnamoorthy |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram India
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9786743120 |
| Fax |
|
| Email |
esenkeyem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya S |
| Designation |
Post Graduate |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram India
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9003268274 |
| Fax |
|
| Email |
divyaroja1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical College and Research Institute Thiruporur Guduvanchery Main Road Ammapettai Nellikuppam Kancheepuram 603108 Tamil Nadu India |
|
|
Primary Sponsor
|
| Name |
Divya S |
| Address |
40, Varadhanar street, Arihant Enclave, A Block, G-5, Vedhachala Nagar, Chengalpattu 603001 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Divya S |
Shri Sathya Sai Medical College and Research Institute |
SURGERY OT number 1 and 2 Second Floor OT Complex , Thiruporur Guduvanchery Main Road, Ammapettai Nellikuppam, Kancheepuram 603108 Kancheepuram TAMIL NADU
Kancheepuram TAMIL NADU
Kancheepuram
TAMIL NADU |
9003268274
divyaroja1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine with Fentanyl |
0.25% of 0.7 ml/Kg Ropivacaine + 1mcg/Kg of Fentanyl with Normal Saline in Caudal Epidural |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Ropivacaine with Fentanyl |
0.25% of 0.7 ml/Kg Bupivacaine + 1mcg/Kg of Fentanyl with Normal Saline in Caudal Epidural |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing infra umbilical surgeries of either sex
American Society of Anaesthesiologist I or II |
|
| ExclusionCriteria |
| Details |
Patients allergic to local anesthetics/Fentanyl
American Society of Anaesthesiologist III and above
Patients with coagulation disorders
Local site infection
Congenital sacral anomalies
Severe CVS abnormalities
Renal or Hepatic Failure
Neuromuscular disorder |
|
|
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 |
| To compare the time taken for regression of motor blockade in terms of post operative early ambulation |
Post Operative Period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess intra operative and post operative hemodynamic stability upto 24 hours
Duration of sensory analgesia and the time to the first demand for rescue analgesia
Post Operative Nausea, Vomiting and Sedation Score |
Intra Operative Period and Post Operative Period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/02/2020 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized controlled trial to compare the efficacy of Ropivacaine with Fentanyl and Bupivacaine with Fentanyl and to assess post operative early ambulation in single shot caudal epidural in paediatric infra umbilical surgeries among 60 patients over a period of 18 months. The primary objective is to To compare the time taken for regression of motor blockade in terms of post operative early ambulation. The secondary outcomes to assess intra operative and post operative hemodynamic stability upto 24 hours, duration of sensory analgesia and the time to the first demand for rescue analgesia and Post Operative Nausea, Vomiting and Sedation Score |