| CTRI Number |
CTRI/2018/09/015673 [Registered on: 11/09/2018] Trial Registered Retrospectively |
| Last Modified On: |
11/09/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare effects of different combinations of drugs when given in caudal block for surgery involving below umblicus. |
|
Scientific Title of Study
|
Comparison of levobupivacaine tramadol with levobupivacaine clonidine in caudal block in children undergoing infraumbilical surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti |
| Designation |
Junior resident |
| Affiliation |
King George medical university |
| Address |
Department of anesthesiology
King George medical university
Lucknow,uttar pradesh
Department of anesthesiology
King George medical university Lucknow,uttar pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9616377999 |
| Fax |
|
| Email |
jyotipoojakuhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinita singh |
| Designation |
Associate professor |
| Affiliation |
King George medical university |
| Address |
Department of anesthesiology
King George medical university
Lucknow,uttar pradesh
Department of anesthesiology
King George medical university Lucknow,uttar pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9616377999 |
| Fax |
|
| Email |
drvinitasingh70@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyoti |
| Designation |
Junior resident |
| Affiliation |
King George medical university |
| Address |
Department of anesthesiology
King George medical university
Lucknow,uttar pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9616377999 |
| Fax |
|
| Email |
jyotipoojakuhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jyoti
Department of Anesthesiology
King George medical university
Shah Mina road,lucknow,Uttar pradesh |
|
|
Primary Sponsor
|
| Name |
Jyoti |
| Address |
Department of anesthesiology
King George medical university
Uttar pradesh |
| 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 |
| Jyoti Rawat |
King geroge medical university |
Department of Anesthesiology
King George medical university
Shah Mina road
Lucknow
Lucknow
UTTAR PRADESH |
9616377999
jyotipoojakuhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
any child undergoing lower abdominal surgery for any disease , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
levobupivacaine 0.25% |
levo bupivaicaine 0.25% given alone in caudal block . |
| Intervention |
Levobupivacaine 0.25% , clonidine |
levobupivacaine 0.25% at 1ml/kg with clonidine at 1ug/kg given in caudal block |
| Intervention |
Levobupivacaine 0.25%, Tramadol |
levobupivacaine 0.25% at 1ml/kg and tramadol 1mg/kg given in caudal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
children in ASA status 1 and 2 undergoing any type of surgical procedure in the lower abdominal region |
|
| ExclusionCriteria |
| Details |
ASA status 3,4 or 5
Any contraindication to caudal block such as scaral agenesis, tumors, local infection
history of seizures
hypersensitivity to any of the drugs in the study |
|
|
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 duration of analgesia in the post operative period |
time duration of analgesia in the post operative period measured at 5, 10, 15,30,45,60,90 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hemodynamic stability in the intra operative period |
5,10,15,30,45,60,90 intra operatively |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
01/05/2018 |
| 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) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be comparing the effect of drug combinations given in caudal block analgesia for the post operative pain relief in the patients. The patients will be children in the age group of 2 to 10 years who will be randomly allocated into 3 groups which will be receiving a particular combination of the drugs. Group I - Levo Bupivacaine 0.25% 1 ml/kg , Group II - Levo Bupivacaine 0.25% 1ml/kg + tramadol 1mg/kg and Group III - Levo bupivacaine 1 ml/kg + Clonidine 1ug/kg after administration of general anaesthesia but before the start of surgery. Outcome will be measured as haemodynamic stability measured in terms of HR, MAP every 5, 10, 15, 30, 45, 60 and 90 mins intra operatively till the completion of the surgery and then duration of post operative analgesia in these patients measured with the help of CHIPPS score and Ramsay sedation score and also hemodynamic parameters at 1 hour interval till the 6th hour and then at 24 hours. |