| CTRI Number |
CTRI/2017/09/009902 [Registered on: 25/09/2017] Trial Registered Prospectively |
| Last Modified On: |
22/09/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISON OF A LOCAL ANAESTHETIC ALONE AND IN COMBINATION WITH AN ANALGESIC AND AN ANTIHYPERTENSIVE DRUG FOR POSTOPERATIVE PAIN RELIEF IN CHILDREN VIA CAUDAL ROUTE. |
|
Scientific Title of Study
|
A comparative study of levobupivacaine, levobupivacaine with ketamine and levobupivacaine with dexmedetomidine in caudal block for post operative pain relief in paediatric patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GANESH KUMAR RAM |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, SHEIKHPURA,PATNA.
Patna
BIHAR
800014
India |
| Phone |
8544117808 |
| Fax |
|
| Email |
GANESHKR05@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
PRAKASH KUMAR DUBEY |
| Designation |
PROFESSOR |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
IGIMS,
Patna
BIHAR
800014
India |
| Phone |
|
| Fax |
|
| Email |
PKDUBEY@HOTMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
PRAKASH KUMAR DUBEY |
| Designation |
PROFESSOR |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
IGIMS,
Patna
BIHAR
800014
India |
| Phone |
|
| Fax |
|
| Email |
PKDUBEY@HOTMAIL.COM |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY, IGIMS, PATNA 800014, BIHAR. |
|
|
Primary Sponsor
|
| Name |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
SHEIKHPURA, PATNA, 800014,BIHAR, INDIA. |
| Type of Sponsor |
Government medical college |
|
|
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 |
| GANESH KUMAR RAM |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES. |
OT COMPLEX,FIRST FLOOR,IGIMS
Patna
BIHAR |
8544117808
8544117808
GANESHKR05@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, SHEIKHPURA, PATNA-14 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
AMERICAN SOCIETY OF ANAESTHESIOLOGY GRADE 1 AND 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LEVOBUPIVACAINE |
LEVOBUPIVACAINE 0.25% AT A DOSE OF 0.75 MILILITER/KG BODY WEIGHT DILUTED IN NORMAL SALINE 0.9% |
| Intervention |
LEVOBUPIVACAINE WITH DEXMEDETOMIDINE |
LEVOBUPIVACAINE 0.25% AT A DOSE OF 0.75 MILILITER/KG OF BODY WEIGHT WITH DEXMEDETOMIDINE 1 MICROGRAM/KG OF BODY WEIGHT |
| Intervention |
LEVOBUPIVACAINE WITH KETAMINE |
LEVOBUPIVACAINE 0.25% AT A DOSE OF 0.75MILILITER/KG OF BODY WEIGHT WITH KETAMINE 0.05% AT A DOSE OF 0.5 MILIGRAM/KG BODY WEIGHT |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1.PATIENTS OF ASA PHYSICAL STATUS 1 AND 2.
2.PATIENTS BETWEEN 3 MONTH TO 7 YEARS OF AGE OF EITHER SEX.
3.PARENTS ABLE TO COMPREHEND TO PARTICIPATE.
4.PATIENTS IN WHOM LEVOBUPIVACAINE IS INDICATED FOR CAUDAL BLOCK. |
|
| ExclusionCriteria |
| Details |
1.PARENTS REFUSAL TO PARTICIPATE.
2.CONTRAINDICATION TO USE OF KETAMINE OR DEXMEDETOMIDINE.
3.PATIENTS WITH KNOWN SENSITIVITY TO LEVOBUPIVACAINE,KETAMINE OF DEXMEDETOMIDINE.
4.PATIENTS ON CONCOMITANT ANALGESIC OR SEDATIVE MEDICATION.
5.PATIENTS WITH PRESENCE OF INFECTION AT THE SITE OF CAUDAL BLOCK,COGULOPATHY OR ANY NEUROLOGICAL ILLNESS. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| POST OPERATIVE PAIN RELIEF BY FLACC SCORE. |
15 MINUTES, 45 MINUTES, 75 MINUTES, 125 MINUTES, 155 MINUTES, 185 MINUTES, 215 MINUTES, 275 MINUTES, 335 MINUTES. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SEDATION, NAUSEA VOMITING, RESPIRATORY DEPRESSION, URINARY RETENTION. |
15 MINUTES, 45 MINUTES, 75 MINUTES, 125 MINUTES, 155 MINUTES, 185 MINUTES, 215 MINUTES, 275 MINUTES, 335 MINUTES. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2017 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
PLAN TO PUBLISH AFTER COMPLETION OF STUDY. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
COMPARATIVE STUDY OF LEVOBUPIVACAINE,LEVOBUPIVACAINE WITH KETAMINE AND LEVOBUPIVACAINE WITH DEXMEDETOMIDINE IN CAUDAL BLOCK FOR POST OPERATIVE PAIN RELIEF IN PAEDIATRICS PATIENTS. |