| CTRI Number |
CTRI/2021/06/034296 [Registered on: 18/06/2021] Trial Registered Prospectively |
| Last Modified On: |
05/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
study to compare two ultrasound guided blocks i.e pectointercostal fascial block and erector spine block in patients undergoing cardiac surgery- a pilot study |
|
Scientific Title of Study
|
A prospective, randomized, single blinded study to compare analgesic efficacy of pectointercostal fascial block and erector spine block in patients undergoing cardiac surgery- a pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
dr manish keshwani |
| Designation |
senior resident |
| Affiliation |
AIIMS, RAIPUR |
| Address |
A-block OT ,4th floor
Department of Anaesthesiology
AIIMS , Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9907177172 |
| Fax |
|
| Email |
manishmkdbest@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samarjit Dey |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, RAIPUR |
| Address |
A-block OT ,4th floor
Department of Anaesthesiology
AIIMS , Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
8014910806 |
| Fax |
|
| Email |
drsamar0002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr manish keshwani |
| Designation |
senior resident |
| Affiliation |
AIIMS, RAIPUR |
| Address |
A-block OT ,4th floor
Department of Anaesthesiology
AIIMS , Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9907177172 |
| Fax |
|
| Email |
manishmkdbest@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR,CHATTISGARH |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| DRMANISH KESHWANI |
AIIMS RAIPUR |
A-block OT ,4th floor
Department of Anaesthesiology
AIIMS
TATIBANDH, RAIPUR
Raipur
CHHATTISGARH |
9907177172
manishmkdbest@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
bilateral erector spine block |
ropivacaine 0.2% 20ml on each side |
| Intervention |
pectointercostal fascial block |
pectointercostal fascial block
ropivacaine 0.2% 20ml on each side |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult (more than 18 years)
Undergoing cardiac surgery with midline sternotomy
Haemodynamically stable
Elective surgery
Extubation within 3 hrs of performing block
|
|
| ExclusionCriteria |
| Details |
Hemodynamic instability (left ventricular ejection fraction <30%, on ventricular assist device)
Aortic surgery
Emergency surgery
Minimally invasive procedures
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
total opioid consumption
|
24hrs after surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
pain at rest
pain on deep breathing |
24 hrs aftersurgery |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/06/2021 |
| Date of Study Completion (India) |
23/11/2021 |
| 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
Modification(s)
|
will send for publication after completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this prospective randomized study patients undergoing cardiac surgery through sternotomy will be recruited and randomized to receive either pectointercostal fascial block or erector spine block bilateral and there analgesia efficacy will be compared after surgery |