| CTRI Number |
CTRI/2015/11/006341 [Registered on: 04/11/2015] Trial Registered Retrospectively |
| Last Modified On: |
02/11/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Will addition of Clonidine prolong the action of Ropivacaine in Transversus Abdominis Block? |
|
Scientific Title of Study
|
Effect of Clonidine as an Adjuvant to Ropivacaine in Ultrasound Guided Transversus Abdominis Plane Block in Pediatric Hernia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sahir Aftab |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
Deprtment Of Anesthesiology,
All India Institute Of Medical Sciences,
Ansari Nagar
New Delhi
South
DELHI
110029
India |
| Phone |
8860135808 |
| Fax |
|
| Email |
sahir.aftab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MKArora |
| Designation |
Professor and Head |
| Affiliation |
|
| Address |
Room No 5011,
Deprtment Of Anesthesiology,
Teaching Block,
All India Institute Of Medical Sciences,
Ansari Nagar,
New Delhi
South
DELHI
110029
India |
| Phone |
9868397806 |
| Fax |
01126588641 |
| Email |
mkarora442@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sahir Aftab |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
Deprtment Of Anesthesiology,
All India Institute Of Medical Sciences,
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
8860135808 |
| Fax |
|
| Email |
sahir.aftab@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences |
| Address |
AIIMS,
Ansari Nagar,
New Delhi |
| 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 Sahir Aftab |
All India Institute of Medical Sciences |
Room No 5011,Departmentof Anaesthesiology,Teaching Block,AIIMS
South
DELHI |
8860135808
sahir.aftab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Inguinal Hernia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TAP Block |
0.5 ml/Kg of 0.375% Ropivacaine is used in TAP block single dose before incision for pediatric hernia surgery |
| Comparator Agent |
TAP Block |
2micrograms/Kg of Clonidine is added to 0.5ml/Kg of 0.375% Ropivacaine in TAP Block single dose before incision for pediatric hernia surgery |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1&2 children for inguinal herniotomy |
|
| ExclusionCriteria |
| Details |
Infection at site of block
Coagulopathy
Allergic to used drugs
Liver or renal disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first analgesic in the postoperative period |
Time to first analgesic in the postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effects of clonidine |
24 hours |
| Total fentanyl requirement |
24 hours |
| Inyraoperative fentanyl requirement |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/12/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Clonidine is an alpha 2 agonist commonly added to local anesthetics to prolong their action.In this study the efficacy of clonidine to prolong postoperative analgesia of ropivacaine in transversus abdominis block(US Guided) for pediatric hernia surgery is assessed. |