| CTRI Number |
CTRI/2024/06/068774 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing Parasternal Intercostal Block for Pain Relief After Heart Surgery at SMS Hospital, Jaipur |
|
Scientific Title of Study
|
A Randomized Controlled Study for The Efficacy Of Parasternal Intercostal Block For Perioperative Analgesia In Cardiac Surgery at SMS Hospital, Jaipur |
| 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 Reema Meena |
| Designation |
Senior professor |
| Affiliation |
Sawai Mansingh Medical College and Hospital,Jaipur |
| Address |
Department of Anaesthesiology Second floor Dhanvantri building
JLN marg Jaipur
Jaipur
RAJASTHAN
302001
India |
| Phone |
9413237117 |
| Fax |
|
| Email |
reemadr.rn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reema Meena |
| Designation |
Senior professor |
| Affiliation |
Sawai Mansingh Medical College and Hospital,Jaipur |
| Address |
Department of Anaesthesiology Second floor Dhanvantri building
JLN marg Jaipur
Jaipur
RAJASTHAN
302001
India |
| Phone |
9413237117 |
| Fax |
|
| Email |
reemadr.rn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr jitendra kumar bairwa |
| Designation |
Junior resident |
| Affiliation |
Sawai Mansingh Medical College Jaipur |
| Address |
Department of Anaesthesiology Second floor Dhanvantri building
JLN marg Jaipur
Jaipur
RAJASTHAN
302001
India |
| Phone |
8504803555 |
| Fax |
|
| Email |
jitendrakumarbairwa95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,SMS Medical College, jAIPUR |
|
|
Primary Sponsor
|
| Name |
Sawai Mansingh Medical College and Hospital |
| Address |
Department of Anaesthesiology, Second floor, Dhanvantri building,
JLN marg, Jaipur. |
| 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 Jitendra kumar bairwa |
sawai man singh medical college and hospital |
Cardiac Surgery
OT Second floor
Bangad building JLN
marg
Jaipur
RAJASTHAN |
8504803555
Jitendrakumarbairwa95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics Comittee,SMS Medical college and attached hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Usg guided Parasternal Intercostal Block |
Group A Parasternal intercostal group n 40 Patients undergoing cardiac surgery under GA and receiving bilateral US guided parasternal intercostal block with 40ml of 0.5% ropivacaine plus 25 microgram fentanyl 4ml in each space from 2nd to 6th intercostal space on each side before incision and local infiltration of 10ml of 0.5% ropivacaine on surgical drainage sites at the end of the surgery
Group B Control group n 40 Patients undergoing cardiac surgery under GA and receiving only local infiltration of surgical drainage site at the end of the surgery
In both the groups intra operative opioid requirement will be assessed through BIS monitoring and for post operative analgesia fentanyl will be given through patient controlled intravenous analgesia pump for 48 hrs |
| Comparator Agent |
parasternal intercostal block
|
To assess the difference in opioid requirement during cardiac surgery between the two group
To assess the difference in post operative VAS between the two groups.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient giving informed written consent
2 All patients between the age group 18-60 years of age scheduled for planned cardiac surgery.
3 ASA grade II & III
|
|
| ExclusionCriteria |
| Details |
1 Skin infection at the puncture site.
2 Allergy to local anaesthetics
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the difference in opioid requirement during cardiac surgery between the two group
To assess the difference in post operative VAS between the two groups
|
assessed immediately,2, 4, 6,12,18,24,30,36,42 and 48 hr post extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the difference in Haemodynamic stability between two groups
To assess the difference in total opioid requirement in 48 hrsTo assess the difference in Haemodynamic stability between two groups
To assess the difference in total opioid requirement in 48 hrs.
To assess the difference in postoperative pulmonary function
Side effects if any
To assess the difference in postoperative pulmonary function
Side effects if any
|
assessed immediately,2, 4, 6,12,18,24,30,36,42 & 48 hr post extubation. |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 2 |
|
Date of First Enrollment (India)
|
05/08/2024 |
| 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="0"
Months="3"
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
|
After obtaining approval from the institutional ethics
committee and written informed consent patients scheduled for heart valve
replacement surgery under general anaesthesia satisfying inclusion criteria
will be enrolled in this study, NBM status, PAC consent will be checked in the
operating room. Patient will be given T. Alprex 0.5mg previous night.
Routine vital
monitors will be attached for ECG, SpO2; EtCO2,entropy. Peripheral IV line, IJV
central line ,arterial line for invasive BP monitoring secured and vitals
(HR,SBP,DBP,CVP) will be noted before induction . After randomization,
patients (n=80) will be allocated into
specific group as per study protocol by sealed
envelope method. Patient will be induced with Inj.Midazolam 0.05mg/kg
and Inj.Fentanyl 4microgram/kg, Inj. Etomidate 0.3mg/kg, Inj. Rocuronium
0.9mg/kg to facilitate tracheal intubation. Patient will be mechanically
ventilated by 100% O2 with tidal volume 6-8ml/kg.EtCo2 35-45mm Hg will be
maintained by adjusting respiratory rate of 12-16 breathe per minute.
In Parasternal intercostal group,
Group A, patients will receive bilateral
USG guided parasternal Intercostal block immediately after induction of
general anaesthesia and intubation. The block will be excecuted
with aseptic technique.The block will be given between the pectoral major and
the intercostal muscles, proximal to the sternum from 2nd to 6th
intercostal spaces..
with 40ml of 0.5% ropivacaine plus 25 microgram fentanyl (4ml in each space from 2nd to 6th intercostal
space on each side) before incision and local infiltration of 10ml of 0.5% ropivacaine
on surgical drainage sites at the
end of the surgery.
In Controlled group: Patients undergoing
cardiac surgery under GA will receive only local infiltration of surgical
drainage site at the end of the surgery. Hemodynamic parameters and fentanyl
requirement will be assessed intraoperatively as per BIS.
In both the groups, patients will be shifted
to ICU after surgery with ETT in situ.
In both the groups, IV fentanyl (25
µg/ml) at a basal infusion rate of 1ml/hour and a bolus of 1ml (fentanyl 25µg)
given by the patient him/herself whenever needed with a lockout interval of 15
minutes for 48 hrs hours after extubation. If the patient will still experience
pain ( VAS>= 4), then Inj tramadol 50mg will be given.
Hemodynamic parameters, fentanyl requirement ,
VAS score and pulmonary function( PEFR by wright’s peak flow meter) will be
assessed immediately,2, 4, 6,12,18,24,30,36,42 and 48 hr post extubation. Side
effects or complications if any will also be noted. End point of the study will
be 48hrs after extubation. |