| CTRI Number |
CTRI/2014/06/004679 [Registered on: 17/06/2014] Trial Registered Retrospectively |
| Last Modified On: |
27/03/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Pain Management in children undergoing Hernia repair |
|
Scientific Title of Study
|
Comparison of Levobupivacaine 0.25% and Bupivacaine 0.25% for Caudal Analgesia in Children Undergoing Herniotomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/06/2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poonam Jadhav |
| Designation |
Assistant Professor Fellow in Paediatric Anaesthesia |
| Affiliation |
Lokmanya Tilak Municipal Medical College and General Hospital |
| Address |
Dept of Anaesthesiology
Lokmanya Tilak Municipal Medical College
Sion Mumbai
Dept of Anaesthesiology
Lokmanya Tilak Municipal Medical College
Sion Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
919819136902 |
| Fax |
|
| Email |
poons910@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Jadhav |
| Designation |
Assistant Professor Fellow in Paediatric Anaesthesia |
| Affiliation |
Lokmanya Tilak Municipal Medical College and General Hospital |
| Address |
D/34 neelima apts jm rd bhandup
D/34 neelima apts jm rd bhandup
Mumbai
MAHARASHTRA
400078
India |
| Phone |
919819136902 |
| Fax |
|
| Email |
poons910@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Jadhav |
| Designation |
Assistant Professor Fellow in Paediatric Anaesthesia |
| Affiliation |
Lokmanya Tilak Municipal Medical College and General Hospital |
| Address |
D/34 neelima apts jm rd bhandup
D/34 neelima apts jm rd bhandup
Mumbai
MAHARASHTRA
400078
India |
| Phone |
919819136902 |
| Fax |
|
| Email |
poons910@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya Tilak Municipal Medical College and General Hospital |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Lokmanya Tilak Municipal Medical College and General Hospital
Sion Mumbai 400022 |
| Type of Sponsor |
Other [Municipal medical college 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 Poonam Jadhav |
Lokmanya Tilak Municipal Medical College and General Hospital |
Department of Anaesthesiology
Sion Mumbai 400 022
Mumbai
MAHARASHTRA |
919819136902
poons910@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lokmanya Tilak municipal medical college and general hospital staff and research society |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
paediatric patients posted for herniotomy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine |
Bupivacaine 0.25% for caudal analgesia for herniotomy |
| Intervention |
Levobupivacaine |
Levobupivacaine 0.25% for caudal analgesia for herniotomy |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
American society of anaesthesiologists Class 1 and Class 2
Paediatric patients scheduled for elective herniotomy |
|
| ExclusionCriteria |
| Details |
history of previous surgeries requiring handling of spinal cord
neurological disorder
cardiac disorder
local infection
pre existing bleeding disorder
hypersensitivity to any drugs
sacral abnormalities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
clinical efficacy of caudal blockade during surgery
residual motor blockade |
caudal block efficacy is absence of gross motor movents or more than 20% change in heart rate and respiratory rate on application of forcep after 15 minutes following caudal block.
residual motor blockade defined as motor block score of more than 1 at wake up and 180 minutes after caudal block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pain scores |
15 minutes for first hour postoperatively and then half hourly for next two hours |
| duration of analgesia |
15 minutes for first hour postoperatively and then half hourly for next two hours |
| requirement of rescue analgesia |
rescue analgesia when pain score of more than 4 |
|
|
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)
|
03/03/2014 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Caudal block is widely used in children, it significantly decreases the requirements of systemic anaesthetic and analgesic agents. This results in better post operative outcome. Bupivacaine has been widely used and extensively studied over decades. The cardiac toxicity of Bupivacaine stimulated interest in developing less toxic , long lasting local anaesthetic.
Levobupivacaine, a pure S enantiomer of bupivacaine, was approved by the US FDA in 1999. It has a wider margin of safety with same analgesic efficacy and less post operative motor blockade. It has been studied extensively in the western world.
Levobupivacaine has been recently introduced in the Indian market. It has been used in paediatric population without any untoward event and with acceptable level of motor blockade. To the best of our nowledge there have been no studies in the Indian paediatric population.
Hence we decided to do an observational study comparing same concentrations of Levobupivacaine and Bupivacaine for caudal analgesia. |