| CTRI Number |
CTRI/2024/08/072269 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
04/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare effectiveness of two regional anaesthesia techniques (Transverse thoracic muscle plane block and Erector spinae plane block)in controlling the pain after cardiac surgery |
|
Scientific Title of Study
|
Comparison of Transverse Thoracic Muscle Plane Block and Erector Spinae Plane
Block for post operative analgesic requirement in Adult Cardiac Surgery:
A Randomized Controlled Non-Inferiority trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amrita Pramod |
| Designation |
Junior Resident |
| Affiliation |
PGIMER, Chandigargh |
| Address |
Department of Anaesthesia and Intensive Care, PGIMER, Chandigargh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7326837231 |
| Fax |
|
| Email |
amrita.pramod75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kulbhushan Saini |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER, Chandigargh |
| Address |
Department of Anaesthesia and Intensive Care,
PGIMER, Chandigargh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9968856948 |
| Fax |
|
| Email |
kulbhushansaini007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kulbhushan Saini |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER, Chandigargh |
| Address |
Department of Anaesthesia and Intensive Care,
PGIMER, Chandigargh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9968856948 |
| Fax |
|
| Email |
kulbhushansaini007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cardiac center, PGIMER, sector12, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, 4th floor, Block A, Nehru hospital, Post Graduate Institute of Medical Education and Research, Chandigrh 160012 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amrita Pramod |
Post Graduate Institute of Medical Education and Reasearch |
CTVS Operation theatre, Cardiac Center, Post Graduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH |
7326837231
amrita.pramod75@gmail.com |
| Dr Kulbhushan Saini |
Post Graduate Institute of Medical Education and Reasearch |
CTVS OT, Advanced Cardiac Center, Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH |
9968856948
kulbhushansaini007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Intramural) Postgraduate Institute of Medical Education and research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R078||Other chest pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erector Spinae Plane Block |
Bilateral Erector Spinae Plane Block with 0.2% Ropivacaine 20ml on each side with 1mcg/kg dexmedetomidine as adjuvant |
| Intervention |
Transverse Thoracic Muscle Plain Block |
Bilateral TTMPB with 0.2% ropivacaine 20ml on each side with 1mcg/kg dexmedetomidine as adjuvant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA status I and II undergoing elective cardiac procedure through
midline sternotomy, CABG where only venous graft is planned ,valve replacement surgery (MVR, AVR, DVR), septal defect surgery
(ASD, VSD) |
|
| ExclusionCriteria |
| Details |
patients who do not volunteer to participate, those who have Ejection fraction less than 35%, those with low cardiac output syndromes. on pre operative ionotropic support, wi9th reccurrent vascular anomalies. those who have allergy to local anaesthetics, those who have severe PAH. If its a reexplporation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
evaluate and compare the cumulative postoperative analgesic requirement (Fentanyl) within the initial 24 hours between two groups: one receiving Thoracic Transversus
Thoracic Muscle Plane Block (TTMPB) ,
and the other receiving Erector Spinae Plane Block (ESPB) |
24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the time to first rescue analgesic (Fentanyl 0.5 mcg/kg) in each group (in
min) to relate to the pain free time.
To assess the analgesic efficacy of TTPMB & ESPB as measured by 11point NRS
scores at 0,6,12 & 24 hrs. post extubation.
To assess & compare the incidence of any complications or adverse events
(hematoma, infection, pneumothorax, pericardial effusion etc.) |
0,6,12,24 hrs |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
16/08/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a prospective randomised non inferiority trail. It compares the post operative analgesia provided by TTMPB and ESPB in patients of 18 to 65 years of age who undergo midline sternotomy for procedures like CABG with only venous graft, MVR, AVR, DVR, VSD and ASD. Patients are screened for inclusion in the study during the pre op evaluation and if they meet the criteria of inclusion and exclusion they are explained about the study and its risk- benefits, written informed consent is taken and also the patient is educated about the NRS pain score. in the OT a skilled anesthetist would provide either of the block depending on the computer generated sequence after induction of the case. during operation fentanyl infusion is maintained and extra bolus dose s are given if required. intraoperative vitals and requirement of fentanyl is noted. Post op patients is transfered to ctvs ICU and hemodynamics guided boluses of fentanyl and provided and note is made. Patient is extubated once they meet the criteria to extubate and time to extubation noted. Post extubation NRS scores noted at predefined intervals and in case of complaints of pain. NRS guided fentanyl bolus doses are given and total quantity of fentanyl requirements post op is also noted for post op 24 hrs. A total of 66 cases are considered to be taken up for the study and conclusion regarding the non inferiority of TTMPB to ESPB will be drawn based on statistical calculation from the data collected. |