| CTRI Number |
CTRI/2024/07/069787 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pain Relief in Minimally Invasive Heart Surgery Using Ultrasound-Guided Erector Spinae Plane Block |
|
Scientific Title of Study
|
A Prospective Study to Assess the Efficacy of USG Guided Erector Spinae Plane Block (ESPB) for Perioperative Analgesia in Patients Undergoing Minimally Invasive Cardiac Surgery (MICS) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dnyaneshwar Wanve |
| Designation |
Resident Doctor |
| Affiliation |
Lokmanya tilak municipal medical college and Lokmanya tilak municipal general hospital sion Mumbai |
| Address |
Department of anaesthesia, 4th floor,College building,Lokmanya Tilak medical college and municipal general hospital sion hospital Mumbai
Mumbai MAHARASHTRA 400022 India |
| Phone |
7972179789 |
| Fax |
|
| Email |
dnyaneshwar111bw@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shakuntala Basantwani |
| Designation |
Additional professor |
| Affiliation |
Lokmanya tilak municipal medical college and Lokmanya tilak municipal general hospital sion Mumbai |
| Address |
Department of anaesthesia, 4th floor,College building,Lokmanya Tilak medical college and municipal general hospital sion hospital Mumbai
Mumbai MAHARASHTRA 400022 India |
| Phone |
9819018461 |
| Fax |
|
| Email |
drbasantwani@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shakuntala Basantwani |
| Designation |
Additional professor |
| Affiliation |
Lokmanya tilak municipal medical college and Lokmanya tilak municipal general hospital sion Mumbai |
| Address |
Department of anaesthesia, 4th floor,College building,Lokmanya Tilak medical college and municipal general hospital sion hospital Mumbai
Mumbai MAHARASHTRA 400022 India |
| Phone |
9819018461 |
| Fax |
|
| Email |
drbasantwani@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya tilak municipal medical college and Lokmanya tilak municipal general hospital sion Mumbai, Maharashtra .Pin code 400022 |
|
|
Primary Sponsor
|
| Name |
Lokmanya tilakMunicipal Medical College and Hospital |
| Address |
Lokmanya Tilak Municipal Medical College and Hospital ,Sion West Mumbai 400022 |
| 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 |
| Dr Dnyaneshwar wanve |
Lokmanya tilak municipal medical college and general hospital sion mumbai |
cardiovascular thoracic surgery operation theatre ,EMS Building ,2nd th floor lokmanya tilak minicipal medical college and Lokmanya tilak municipal general hospital sion Mumbai Mumbai MAHARASHTRA |
7972179789
dnyaneshwar111bw@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE, SION MUMBAI - 400022 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing MICS
Many types of heart procedure may be performed with MICS including - coronary artery bypass graft, aortic valve replacement, atrial septal defect, mital valve repair or replacement, tricuspid valve repair or replacement |
|
| ExclusionCriteria |
| Details |
-Patients refusal to participate in study
-Allergy to Local anaesthetic agents
-History of substance abuse
-Emergency Surgery.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intraoperative analgesics requirement
Duration of Erector spinae block
Post op Requirement of Rescue analgesics in 24 hrs
|
0 HRS 2HRS 6HRS 12HRS 24 HRS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Extubation Time
2. 1st Mobilisation time
|
0 HRS 2HRS 6HRS 12HRS 24 HRS |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
15/07/2024 |
| 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 Applicable |
| 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
|
This prospective observational study aims to evaluate the efficacy of ultrasound-guided Erector Spinae Plane Block (ESPB) for perioperative analgesia in patients undergoing Minimally Invasive Cardiac Surgery (MICS) at Lokmanya Tilak Municipal General Hospital, Mumbai.
Objective: -The primary objective of this study is to assess the impact of ESPB on intraoperative analgesic requirements, duration of postoperative analgesia, and the need for rescue analgesics within the first 24 hours post-surgery. Secondary objectives include evaluating extubation time, time to first mobilization, and patient and surgeon satisfaction scores.
Methodology:- The study will include 30 adult patients scheduled for various MICS procedures, such as coronary artery bypass surgery, valve repairs, or septal defect corrections. Patients meeting inclusion criteria (age over 18 years, elective surgery, ability to provide informed consent) and not having any exclusion criteria (allergy to local anesthetics, history of substance abuse) will be enrolled after obtaining informed consent. Standard monitoring and anesthesia induction will be performed according to institutional protocols, with intravenous dexmedetomidine and atracurium used for maintenance. ESPB will be performed under ultrasound guidance at the T5 level using a high-frequency linear ultrasound transducer and a 20-gauge echogenic needle. A total of 20 ml of Ropivacaine 0.125% with Dexamethasone 8 mg will be administered in the ESPB procedure.
Outcome Measures:-Primary outcomes include intraoperative analgesic requirements, duration of analgesia post-administration, and the need for rescue analgesics within 24 hours. Secondary outcomes involve assessing extubation time, time to first mobilization, and patient and surgeon satisfaction scores. Pain intensity will be assessed using the Numerical Rating Scale (NRS) at baseline, intraoperatively, and at 0, 2, 6, 12, and 24 hours postoperatively. Rescue analgesic administration will be recorded and analyzed for efficacy.
Statistical Analysis:-Descriptive statistics will summarize demographic and clinical characteristics, while inferential statistics (e.g., Z-test, Mc Nemar’s Chi-square test) will compare pre- and post-block outcomes. Statistical analysis will be conducted using STATA version 10.1, with a significance level set at p < 0.05.
Conclusion:- This study aims to contribute evidence on the efficacy of ESPB in enhancing perioperative pain management and recovery outcomes in patients undergoing MICS. The findings are expected to support the adoption of ESPB as an alternative or adjunct to systemic opioids in cardiac surgery, potentially leading to improved patient care and outcomes.
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