| CTRI Number |
CTRI/2024/02/062531 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Other (Specify) [ultrasound guided block] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
It is a study to observe the effect of ultrasound guided Pecto-Intercostal Fascial Plane Block (PIFB) for post sternotomy pain in patients undergoing cardiac surgery |
|
Scientific Title of Study
|
Efficacy of Pectointercostal fascial plane block for post sternotomy pain in patients undergoing cardiac surgery |
| Trial Acronym |
PIFB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Geeta Ahlawat |
| Designation |
Professor - |
| Affiliation |
Pt. B.D. Sharma Rohtak |
| Address |
Room no 2 first floor
Dept of Cardiac Anaesthesia
Lala Shyam Lal Building
Pt. B.D. Sharma
Post Graduate Institute of Medical Sciences
Rohtak
Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9540642640 |
| Fax |
|
| Email |
drgeetasaroha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepika Budhwar |
| Designation |
DM Cardiac Anaesthesia Resident |
| Affiliation |
Pt. B.D. Sharma Rohtak |
| Address |
Room no 3 first floor
Lala Shyam Lal building
Dept of Cardiac Anaesthesia
Pt. B.D. Sharma
Post Graduate Institute of Medical Sciences
Rohtak
Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9540642640 |
| Fax |
|
| Email |
deepikabudhwar212@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepika Budhwar |
| Designation |
DM Cardiac Anaesthesia Resident |
| Affiliation |
Pt. B.D. Sharma Rohtak |
| Address |
Room no 3 first floor
Lala Shyam Lal building
Dept of Cardiac Anaesthesia
Pt. B.D. Sharma
Post Graduate Institute of Medical Sciences
Rohtak
Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9540642640 |
| Fax |
|
| Email |
deepikabudhwar212@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiac Anaesthesia First Floor
Lala Shyam Lal Building
Pt.B.D. Sarma PGIMS Rohtak
Haryana-124001 India |
|
|
Primary Sponsor
|
| Name |
Pt.B.D. Sarma PGIMS Rohtak |
| Address |
Dept of Cardiac Anaesthesia
Pt. B.D. Sharma
PGIMS
Rohtak
Haryana |
| 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 Deepika Budhwar |
Pt.B.D Sharma PGIMS |
CTVS operation theatre, first floor
Department of Cardiac Anaesthesia
Lala Shyam Lal Building
Rohtak
HARYANA |
9540642640
deepikabudhwar212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research 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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
USG guided PIFB block |
patients undergoing open cardiac surgeries will receive ultrasound guided pectoitercostal fascial plane block with ropivaciane and fentany after induction of anaesthesia before surgical incision and will be compared with control group (those not receiving USG guided PIFB) |
| Intervention |
USG guided PIFB block |
patients undergoing open cardiac surgeries will receive ultrasound guided pectoitercostal fascial plane block with ropivaciane and fentanyl after induction of anaesthesia before surgical incision |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
elective cardiac surgery with median sternotomy
ASA I-III
|
|
| ExclusionCriteria |
| Details |
emergency surgery
redo surgery
known allergy to ropivacaine
platelet count less than one lakh
infection at the needle insertion site
a history of opioid abuse
hepatic or renal failure
congestive heart failure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of post sternotomy pain using Numerical Rating Scale (NRS) in patients receiving bilateral USG guided Pecto-Intercostal Fascial Plane Block (PIFB) as compared to those not receiving the block |
at extubation
2 hours
4 hours
8 hours
16 hours
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
time to ambulation
removal of chest tubes
nausea
vomiting |
after extubation |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
USG guided Pecto-Intercostal Fascial Plane Block (PIFB) is a safe and effective analgesic technique for treatment of post sternotomy pain after cardiac surgery. This is a relatively new technique, we therefore plan to to study the safety profile and effectiveness of the USG guided Pecto-Intercostal Fascial Plane Block. |