| CTRI Number |
CTRI/2024/07/071646 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare effect of ropivacaine in postoperative pain in SAPB block and PEC block in minimal invasive cardiac surgeries. |
|
Scientific Title of Study
|
A comparative evaluation of post operative pain between ultrasound guided post operative serratus anterior plane block (SAPB) and pectoral nerve block (PEC II) in adult patients undergoing minimal invasive cardiac surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deeksha Yadav |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Jawaharlal Nehru Medical College,AMU |
| Address |
Department of Anaesthesiology and critical care, jawaharlal nehru medical college, AMU, Aligarh.
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7906371126 |
| Fax |
|
| Email |
dydeeksha310896@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nadeem Raza |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College,AMU |
| Address |
Department of Anaesthesiology and critical care, jawaharlal nehru medical college, AMU, Aligarh.
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7417795018 |
| Fax |
|
| Email |
nadeemraza03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deeksha Yadav |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Jawaharlal Nehru Medical College,AMU |
| Address |
Department of Anaesthesiology and critical care, jawaharlal nehru medical college, AMU, Aligarh.
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7906371126 |
| Fax |
|
| Email |
dydeeksha310896@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical care Jawaharlal Nehru Medical College, AMU, Aligarh, 202001, Uttar Pradesh, India. |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and critical care |
| Address |
Department of Anaesthesiology and critical care, jawaharlal nehru medical college, AMU, Aligarh,202001, Uttar Pradesh. |
| 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 Deeksha Yadav |
Jawaharlal nehru medical college |
Department of Anaestheisology and critical care, JNMCH, AMU, Aligarh
Aligarh
UTTAR PRADESH |
7906371126
dydeeksha310896@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Regd.) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: I39||Endocarditis and heart valve disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Postop pain |
measuring degree of pain relief in post operative period via NRS score |
| Intervention |
SAPB block and PEC 2 block |
post operative SAPB and PEC block will be given in OT, later patient will be extubated in ICU in absence of primary doctor.
Total duration will be till the patient is in ICU. Total ICU duration will be noted. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing elective MICS via thoracotomy incision with BMI 18 to 30 kg per metre sqaure . |
|
| ExclusionCriteria |
| Details |
patients with extubation time more than 3 hours, and patients getting reintubated with in 24 hour of extubation, patients with symptomatic CHF, coagulation disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare degree of pain relief in postoperative period in SAPB and PEC II block. |
via using NRS scale for 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. 24 hour cumulative opioid consumption post extubation
2. time to extubation
3. duration of icu stay
4. complication if any. |
T1- 3hrs from block
T2- NRS score at 0,2,6,12,24 hr. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
29/08/2024 |
| 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="2"
Months="0"
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
|
Tracheal intubation and extubation are critical steps during anaesthetic care where cardiovascular and respiratory decompression can occur such as tachycardia, hypertension, arrythmias, myocardial ischaemia,bradycardia or laryngospasm. These potentially fatal complication related to extubation results from stimulation of the larynx, trachea and bronchi which increase the release of catecholamine concentration. |