| CTRI Number |
CTRI/2019/05/019201 [Registered on: 16/05/2019] Trial Registered Prospectively |
| Last Modified On: |
15/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two different combination of medicines given just before incision of abdomen surgery |
|
Scientific Title of Study
|
Comparision of efficacy of Bupivacaine plus Tramadol with Bupivacaine plus Dexmedetomidine as preincisional infiltration in patients undergoing abdominal surgery under general anaesthesia : A Prospective Randomised Double Blinding Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajit Kumar |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
First Floor, Ward Block, Department of Anaesthesiology and Critical Care Medicine, IGIMS
Sheikhpura, Bailey Road
Patna
BIHAR
800014
India |
| Phone |
7004882143 |
| Fax |
|
| Email |
ajit.nmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Kumar Verma |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
First Floor, Ward Block, Department of Anaesthesiology and Critical Care Medicine, IGIMS
Sheikhpura, Bailey Road
Patna
BIHAR
800014
India |
| Phone |
9473191825 |
| Fax |
|
| Email |
drvvinodv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod Kumar Verma |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
First Floor, Ward Block, Department of Anaesthesiology and Critical Care Medicine, IGIMS
Sheikhpura, Bailey Road
BIHAR
800014
India |
| Phone |
9473191825 |
| Fax |
|
| Email |
drvvinodv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences
Sheikhpura, Bailey Road, Patna 800014, Bihar |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute of Medical Sciences |
| Address |
First Floor, Ward Block, Department of Anaesthesiology and Critical Care Medicine, Sheikhpura, Bailey Road, Patna 800014, Bihar |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ajit Kumar |
Indira Gandhi Institute of Medical Sciences
First Floor, Ward Block, Department of Anaesthesiology and Critical Care Medicine, Sheikhpura, Bailey Road, Patna 800014, Bihar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajit Kumar |
Indira Gandhi Institute of Medical Sciences |
First Floor, Ward Block, Department of Anaesthesiology, Sheikhpura, Bailey Road
Patna
BIHAR |
700488143
ajit.nmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine and Bupivacaine |
1 mcg/kg Dexmedetomidine in 0.2 ml/kg of 0.25% Bupivacaine
Route - Subcutaneous local infiltration
Frequency - once
Duration - 1 to 2 minutes
|
| Comparator Agent |
Tramadol and Bupivacaine |
2mg/kg Tramadol in 0.2 ml/kg of 0.25% of Bupivacaine
Route - Subcutaneous local infiltration
Frequency - once
Duration - 1 to 2 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA physical status 1 and 2
Patients willing to participate
Patients undergoing abdominal surgery |
|
| ExclusionCriteria |
| Details |
Patients refusal to participate
Patients with pregnancy, morbid obesity, full stomach and emergency surgery
Patients with ASA physical status 3 and above
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Bupivacaine plus tramadol vs Bupivacaine plus dexmedetomidine as preincisional infiltration. |
From administration of drug to upto 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the post operative effect of analgesia in both groups. |
From administration of drug to upto 24 hours after surgery |
|
|
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)
|
26/05/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We plan to compare the analgesic effect of pre incisional infiltration of Bupivacaine plus tramadol vs Bupivacaine plus dexmedetomidine in patients undergoing abdominal surgery under general anaesthesia. |