| CTRI Number |
CTRI/2019/04/018824 [Registered on: 29/04/2019] Trial Registered Prospectively |
| Last Modified On: |
14/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparitive study on pain management in off pump coronary artery bypass grafting |
|
Scientific Title of Study
|
A comparitive study of bilateral errector spinae block and intravenous dexmeditomidine for perioperative pain management in patients undergoing off pump coronary artery bypass grafting - A single blinded randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
V RAJESH KUMAR KODALI |
| Designation |
Associate professor in department of Anesthesiology |
| Affiliation |
sri ramachandra institute of highereducation and research |
| Address |
Department of Anesthesiology
sri ramachandra institute of higher education and research
porur
chennai
F6 cardiothoracic ICU
udayar block
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9444230150 |
| Fax |
|
| Email |
vrajesh.kodali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
V RAJESH KUMAR KODALI |
| Designation |
Associate professor in department of Anesthesiology |
| Affiliation |
sri ramachandra institute of highereducation and research |
| Address |
Department of Anesthesiology
sri ramachandra institute of higher education and research
porur
chennai
F6 cardiothoracic ICU
udayar block
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9444230150 |
| Fax |
|
| Email |
vrajesh.kodali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
V RAJESH KUMAR KODALI |
| Designation |
Associate professor in department of Anesthesiology |
| Affiliation |
sri ramachandra institute of highereducation and research |
| Address |
Department of Anesthesiology
sri ramachandra institute of higher education and research
porur
chennai
F6 cardiothoracic ICU
udayar block
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9444230150 |
| Fax |
|
| Email |
vrajesh.kodali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology,sriramachandra institute of higher education and research,porur,chennai |
|
|
Primary Sponsor
|
| Name |
Vrajesh kumar kodali |
| Address |
sri ramachandra institute of higher education research,f 6 cardio thoracic ICU,udayar block,porur,chennai |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 |
| v rajesh kumar kodali |
Sri ramachandra medical college |
Department of anesthesiology, f6 cardiothoracic ICU
Udayar block,porur,chennai
Chennai
TAMIL NADU |
9444230150
vrajesh.kodali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sriramachandra institute of higher education and research institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (2) ICD-10 Condition: I208||Other forms of angina pectoris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
bilateral errector spinae plane block given with 20 ml of 0.25% bupivacaine withadjuvant of inj.dexmeditomidine 0.5 mcg/kg on right side,20 ml of 0.25% bupivacaine 0.5 mcg/kg dexmeditomidine on left side are going to be given. |
post op pain score measured with numjerical rating score at 2,4,6,8,12 hrs.rescue analgesia given with inj.fentanyl/inj.paracetamol if pain score is above 4 |
| Comparator Agent |
inj dexmeditomidine intravenous bolus given 5-10 minutes before skin incision and continuous infusion 0.3-0.5 mcg/kg/hr infusion going to start after bolus and will be continued for 24 hours. |
post op pain score measured with numjerical rating score at 2,4,6,8,12 hrs.rescue analgesia given with inj.fentanyl/inj.paracetamol if pain score is above 4 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged18 -70 years undergoing elective off pump coronary artery bypass grafting with ejection fraction (EF) more than 45%. |
|
| ExclusionCriteria |
| Details |
Patients with EF less than 45% Patients with anomalies of vertebral column (kyphosis,scolisis) Emergency off pump coronary artery bypass grafting Patients who are on IABP preoperative period Acute myocardial infarction Patients with bleeding diathesis
Patients on anticoagulants and who stopped clopidogrel within 5 days.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post op analgesia measurement with Numerical rating scale NRS score |
Post op analgesia measurement with Numerical rating scale NRS score 0-10 at 2 hrs ,4hrs ,6hrs,,8 hrs,12 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| duration of ventilation,duration of icu stay,total number of rescue analgesic doses required are to be noted |
duration of ventilatio noted 10 minutes,30 minutes,1 hour,2 hrs,4 hrs,8 hrs.
duration of icu stay noted in terms of number of hours in icu
total number of rescus anagesic doses like no rescue anagesic requirement to 1 dose ,2 times,4 times are going to be noted |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/05/2019 |
| Date of Study Completion (India) |
14/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="10"
Months="1"
Days="6" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Total 110 patients are going to be recruited in study after CTRI Approval.one group of patients will receive continuous errector spiunae block for 24 hrs,other group will receive dexmeditomidine infusion primary outcome .pain score at 2 hrs,4 hrs,6 hrs, 8 hrs,12 hrs are measured.secondary outcomes are duration of ventilation,duration of icu stay and total number of rescue analgesic doses required are to be noted |