| CTRI Number |
CTRI/2024/12/078400 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Erector Spinae Block on NLR in CABG patients |
|
Scientific Title of Study
|
To Compare Effect of Erector spinae Block on Neutrophil Lymphocyte Ratio in patients undergoing On Pump CABG |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pulipaka Sai Dheeraj |
| Designation |
Resident Anaesthesia |
| Affiliation |
Resident Anaesthesia |
| Address |
Department of Anaesthesia and Critical care AFMC Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7893839444 |
| Fax |
|
| Email |
dheerajanaesthesia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alok Kumar |
| Designation |
Professor |
| Affiliation |
Armed forces medical college |
| Address |
Department of Anaesthesia Aicts Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
8146044104 |
| Fax |
|
| Email |
mipayal07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alok Kumar |
| Designation |
Professor |
| Affiliation |
Armed forces medical college |
| Address |
Department of Anaesthesia Aicts Pune
MAHARASHTRA
411040
India |
| Phone |
8146044104 |
| Fax |
|
| Email |
mipayal07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical care
Armed forces medical college
Pune 411040 |
|
|
Primary Sponsor
|
| Name |
Pulipaka Sai Dheeraj |
| Address |
Department of Anaesthesiology and critical care
Armed Forces Medical College
pune 411040 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr PS Dheeraj |
Armed Forces Medical college |
Department of Anaesthesiology and critical care , AFMC Pune
Pune
MAHARASHTRA |
7893839444
dheerajanaesthesia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: I220||Subsequent ST elevation (STEMI) myocardial infarction of anterior wall, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae block |
Erector spinae block Will be given after induction with 0.125% Bupivacaine and 2mcg/ml Fentanyl at 3 to 5ml /hr infusion uptill 48hrs Postoperative period |
| Comparator Agent |
Opioid group |
No block will be given to this arm Morphine infusion will be given to patient intravenously at the rate of 3 to 5ml /hr infusion uptill 48hrs Postoperative period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients |
|
| ExclusionCriteria |
| Details |
Severe LV dysfunction,pre-existing coagulopathy,patient refusal,pre-existing site infection ,patient preoperatively on ventilator |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreased NLR in Erector spinae block group compared to opioid group |
Postoperative Day 0, 1 and 2 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Decreased PLR in Erector spinae block group compared to opioid group |
Pod 1 ,2 |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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 4 |
|
Date of First Enrollment (India)
|
30/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction: In cardiac surgery, owing to surgical manipulation, pain is considered severe. Inflammation and pain are interrelated, Neutrophil-lymphocyte ratio (NLR) Predicts the surgery induced inflammation in cardiac surgery patients. Regional anesthesia techniques modulate the inflammatory response as a result of surgical injury with various mechanisms at different levels This study aimed to investigate the effects of ESP block employed for postoperative analgesia in cardiac surgery on surgery-induced inflammation using NLR. Methodology: Patients underwent either an ESP block or a conventional analgesia technique for CABG surgery (20 patients in each arm). ESPB infusion was continued till post op day 2. The NLR ratio and VAS scores were sequentially noted till 48 hr postoperatively. MV duration and intensive care unit (ICU) length of stay was also noted. |