| CTRI Number |
CTRI/2024/06/069122 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/06/2024 |
| 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 usefulness of two ultrasound guided chest blocks for pain relief after heart surgery. |
|
Scientific Title of Study
|
Comparison of ultrasound guided pecto intercostal fascial block and transversus thoracic muscle plane block for quality of recovery after cardiac surgery requiring median sternotomy A prospective randomize double blind study |
| 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 Monika Soni |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anesthesiology Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna
Patna
BIHAR
800014
India |
| Phone |
8722929388 |
| Fax |
|
| Email |
monikasoni97.ms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alok Kumar Bharti |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anesthesiology Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna
Patna
BIHAR
800014
India |
| Phone |
6392180381 |
| Fax |
|
| Email |
alok.bharti48@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alok Kumar Bharti |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anesthesiology Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna
Patna
BIHAR
800014
India |
| Phone |
9307645596 |
| Fax |
|
| Email |
alok.bharti48@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, Bihar, India, 800014 |
|
|
Primary Sponsor
|
| Name |
Dr Monika Soni |
| Address |
Department of Anesthesiology Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, Bihar, India, 800014 |
| 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 Monika Soni |
Indira Gandhi Institute of Medical Sciences, Sheikapura |
Department of Anesthesiology, First floor
Patna
BIHAR |
8722929388
monikasoni97.ms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Indira Gandhi Institute Of Medical Sciences, Patna |
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, (2) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pecto- intercostal Fascial Plane Block |
Group PIFB will receive 20mL of 0.5% of ropivacaine on each side of sternum + LA infiltration (10mL, 0.5% ropivacaine) around chest tubes half an hour before incision to assess Quality of Recovery (QoR) at 24 hours. |
| Intervention |
Transversus Thoracic Muscle Plane Block |
Group TTMPB will receive 20mL of 0.5% ropivacaine on each side of sternum + LA infiltration (10ml, 0.5% ropivacaine) around chest tubes half an hour prior to incision to aseess Quality of Recovery at 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status 2 or 3
2. Patients able to comprehend and willing to participate.
3. Patients scheduled for elective on pump cardiac surgery requiring median sternotomy. |
|
| ExclusionCriteria |
| Details |
1. Patients refusal to participate
2. Patients with left venticular ejection fraction less than 30%
3. Emergent or redo surgeries
4. Studied drug allergy
5. Hematological disease or h/o bleeding diathesis
6. Chronic Opioids use
7. Severe organ dysfunction (Renal/ Liver insufficiencies). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of recovery, using the Quality of Recovery- 15 (QoR- 15) scale at 24 h post- operatively |
At 24 h post- operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess pain score using NRS scale upto 24 hr, time to first rescue analgesia use, total analgesic consumption upto 24 hr, patients satisfaction and any adverse effects seen. |
pain score will be recorded at rest and during coughing using NRS scores at 0, 3, 6, 12, 18 and 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="6"
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
|
A total of 60 patients posted for elective cardiac surgery requiring median sternotomy will be randomly divided into two equal groups (30 each), group PIFB and group TTMPB. We will compare the effectiveness of ultrasound- Guided Pecto- Intercostal Fascial Block and Transversus Thoracic Muscle Plane Block. Post operatively, pain scores will be recorded at rest and during coughing using 11- point Numeric Rating Scale (NRS) at 0,3,6,12,12, and 24 hours. On assessment, if NRS is 3 or more, first rescue analgesia (iv diclofenac sodium 1mg/kg) will be administered. Patient will be reassessed after 30 minutes; if NRS persists to be 3 or more, a second rescue analgesia (iv tramadol 2mg/kg) will be given. Duration of analgesia will be recorded. Quality of recovery (QoR) will be assessed using Quality of Recovery- 15 (QoR- 15) scale at 24 hours post operatively. Patients satisfaction with pain management will be evaluated using a five- point verbal satisfaction scale (Likert scale) at the end of first 24 postoperative hours. Hemodynamic parameters and side effects like respiratory depression and pruritis will be recorded. |