| CTRI Number |
CTRI/2024/03/064524 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Levobupivacaine 0.25% and Ropivacaine 0.25% for caudal epidural anaesthesia for infra umbilical surgeries in children |
|
Scientific Title of Study
|
Comparison of Levobupivacaine 0.25% and Ropivacaine 0.25% for caudal epidural anaesthesia in children undergoing infra umbilical surgeries - a randomised clinical trial |
| 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 Manchikanti V D Avinash |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department Of Anaesthesiology,
Jawaharlal Nehru Medical College , Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
9912148010 |
| Fax |
|
| Email |
dr.dhanunjaya24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANJUNATH C PATIL |
| Designation |
PROFESSOR |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
JAWAHARLAL NEHRU MEDICAL COLLEGE
Belgaum
KARNATAKA
590010
India |
| Phone |
9743110637 |
| Fax |
|
| Email |
mcpatil52@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjunath c Patil |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department Of Anaesthesiology,
Jawaharlal Nehru Medical College , Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
9743110637 |
| Fax |
|
| Email |
mcpatil52@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology ,
Jawaharlal Nehru Medical College , Nehru Nagar , Belagavi, Karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Manchikanti V D Avinash |
| Address |
Department Of Anesthesiology,
Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi , Karnataka 590010 |
| 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 Manchikanti V D Avinash |
KLE DR PRABHAKAR KORE HOSPITAL |
Department Of Anaesthesiology,
Jawaharlal Nehru Medical College , Nehru Nagar , Belagavi , Karnataka
Belgaum
KARNATAKA |
9912148010
dr.dhanunjaya24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levobupivacaine |
Patient will recieve 1ml per kg body weight of 0.25% of Levobupivacaine for caudal epidural anaesthesia and observe for every 5 minutes till 60 minutes |
| Comparator Agent |
Ropivacaine |
Patient will recieve 1ml per kg body weight of 0.25% of Ropivacaine for caudal epidural anaesthesia and observe for every 5minutres till 60 minutes |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA 1 AND 2
2.Patients undergoing elective infraumbilical surgeries
3.Parental consent
4.Duration of surgery less than 1 hour |
|
| ExclusionCriteria |
| Details |
1.Patients who are allergic to local anaesthetics
2. Patients with coagulation abnormalities
3.Patients with spinal abnormalities and neurological deficits.
4. Patients with infection at the site of block |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of analgesia and drug with less toxic effect of 0.25% Levobupivacaine and 0.25% Ropivacaine in Paediatric patients undergoing infra umbilical surgeries under caudal epidural anaesthesia. |
5,10,15,20,25,30,35,40,45,50,55 and 60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of post operative analgesia and complications if any |
5,10,15,20,25,30,35,40,45,50,55 and 60 minutes |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Paediatric Regional anaesthesia is an excellent technique for balanced intraoperative and post operative analgesia . Hence in this study I am comparing two drugs to achieve the same. This study will be helpful in selecting an appropriate drug with lesser toxic effect and better analgesic efficiency for caudal epidural anaesthesia in paediatric patients |