| CTRI Number |
CTRI/2023/08/056787 [Registered on: 23/08/2023] Trial Registered Prospectively |
| Last Modified On: |
21/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to compare "levobupivacaine with dexmeditomidine " and "levobupivacaine with dexamethasone " in caudal block for postoperative analgesia |
|
Scientific Title of Study
|
A Comparative study of levobupivacaine 0.25% with dexmeditomidine and dexamethasone as adjuvant in caudal block for paediatric patients undergoing infraumbilical surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Batula Shravani |
| Designation |
Student jr2 |
| Affiliation |
Gajra raja medical college gwalior |
| Address |
Department of Anaesthesiology Grmc Gwalior Madhya pradesh 474009 India
Gwalior
Madhyapradesh
474009
India
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
7013843124 |
| Fax |
|
| Email |
battulashravani0014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Neelima Tandon |
| Designation |
Professor |
| Affiliation |
Gajra raja medical college gwalior |
| Address |
Department of Anaesthesiology Grmc Gwalior
Madhyapradesh 474009 India
Gwalior
Madhyapradesh
474009
India
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
7013843124 |
| Fax |
|
| Email |
dr.neelimatandon21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Batula Shravani |
| Designation |
Student jr2 |
| Affiliation |
Gajraraja medical college Gwalior |
| Address |
Department of Anaesthesiology Grmc Gwalior Madhyapradesh 474009 India
Gwalior
Madhyapradesh
474009
India
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
7013843124 |
| Fax |
|
| Email |
battulashravani0014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gajra raja medical college Grmc Gwalior Madhyapradesh 474009 India |
|
|
Primary Sponsor
|
| Name |
DR Batula Shravani |
| Address |
Department of Anaesthesiology Grmc Gwalior Madhyapradesh 474009 India |
| 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 |
| DR Batula Shravani |
Gajraraja medical college and Jah hospital |
Department of Anaesthesiology Grmc Gwalior Madhyapradesh 474009 India
Gwalior
MADHYA PRADESH |
7013843124
battulashravani0014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Gajraraja Medical college gwalior |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N430||Encysted hydrocele, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone |
1ml/kg dexamethasone with 0.25% levobupivacaine in caudal block in childern undergoing infraumbilical surgeries within 6months of duration |
| Comparator Agent |
Dexmeditomidine |
1ug/kg Dexmeditomidine with levobupivacaine in caudal block in childerns undergoing infraumbilical surgeries within 6months of duration |
| Intervention |
Levobupivacaine |
0.25% Levobupivacaine 1ml/kg in caudal block in children undergoing infraumbilical surgeries within 6months of duration |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing infraumbilical surgeries Parents or guardian giving consent to participate in study of age between 1year to 8years of ASA Grade I and II |
|
| ExclusionCriteria |
| Details |
Patients guardian not giving consent to participate in the study
ASA Grade III and IV
Patients with known hypersenstivity to local anaesthestics
Abnormal coagulopathy
Preexisting neurological disease
Local sepsis or infection
Mentally retarded child
Abnormal sacral anatomy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Its Expected that moderate dose of caudal analgesia with 0.25% levobupivacaine 1ml/kg with dexmeditomidine is more effective than 0.25% levobupivacaine 1ml/kg with dexamethasone |
24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a Prospective double blind randomised control study comparing evaluation of 0.25% levobupivacaine with Dexmeditomidine 1ug/kg and 0.25% Levobupivacaine with 1mg/kg dexamethasone in Caudal block in Children undergoing infraumbilical surgeries ,in this study we are comparing postoperative analgesic effect of both the drugs. |