| CTRI Number |
CTRI/2019/02/017870 [Registered on: 28/02/2019] Trial Registered Prospectively |
| Last Modified On: |
27/02/2019 |
| 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 Fentanyl and Clonidine for post operative pain relief when added to Ropivacaine in caudal epidural for children who undergo surgeries below the umbilicus |
|
Scientific Title of Study
|
Efficacy of Fentanyl vs Clonidine as an adjuvant to Ropivacaine compared to Ropivacaine for postoperative analgesia in caudal block for infraumbilical surgeries: A Prospective double blinded randomized control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
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|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balu Sankar J |
| Designation |
PG Resident |
| 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 603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
8547045150 |
| Fax |
|
| Email |
bsj91sankar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S N Krishnamurthy |
| 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 603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9786743120 |
| Fax |
|
| Email |
esenkeyem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Balu Sankar J |
| Designation |
PG Resident |
| 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 603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
8547045150 |
| Fax |
|
| Email |
bsj91sankar@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 |
|
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Primary Sponsor
|
| Name |
Balu Sankar J |
| Address |
Vysakh Puthiyavila
Pattolimarket PO
Alapuzha 690531
Kerala, India |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Balu Sankar J |
Shri Sathya Sai Medical College and Research Institute |
Surgery OT 1 and 2, Ortho OT
Second Floor OT complex
Shri Sathya Sai Medical College and Research Institute
Thiruporur Guduvanchery Main Road
Ammapettai Nellikuppam
Kancheepuram 603108
Kancheepuram
TAMIL NADU |
8547045150
bsj91sankar@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethics Committe |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K35-K38||Diseases of appendix, (2) ICD-10 Condition: M84||Disorder of continuity of bone, (3) ICD-10 Condition: K40-K46||Hernia, (4) ICD-10 Condition: N30-N39||Other diseases of the urinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clonidine |
As adjuvant to Ropivacaine in Caudal Epidural |
| Intervention |
Fentanyl |
As adjuvant to Ropivacaine in Caudal Epidural |
| Comparator Agent |
Ropivacaine |
To be used in Caudal Epidural |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS 1 and 2
Weight between 10 and 30 Kilograms |
|
| ExclusionCriteria |
| Details |
Refusal for caudal block
ASA 3 and above physical status
Allergic to local anaesthetics and adjuvants
Children less than 2 years of age
Infection at block site
Bleeding diasthesis, pre-existing neurological, spinal diseases, mental retardation, neuromuscular disorders |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To study the duration of analgesia in terms of pain score and total analgesic requirement. |
Post Operative Period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study sedation, hemodynamic changes, incidence of nausea, vomiting and pruritis |
Intraoperative and post operative period. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
05/03/2019 |
| 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)?
|
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Brief Summary
|
This is a prospective double blinded randomised control study to compare the efficacy of fentanyl and clonidine as an adjuvant to ropivacaine and with ropivacaine alone in caudal block for 72 pediatric patients posted for infraumbilical surgeries. The primary outcome is to study the duration of analgesia in terms of pain score and total analgesic requirements. The secondary objectives are to study the level of sedation, hemodynamic changes, incidence of nausea, vomiting and pruritis. |