| CTRI Number |
CTRI/2024/09/073747 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| 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 the effects of two nerve blocks which are meant for pain relief by blocking the nerves supplying the area of surgery |
|
Scientific Title of Study
|
Comparison of ultrasound guided Pecto intercoastal fascial block and Transversus thoracic muscle plane block for post operative analgesia in patients undergoing cardiac surgery through midline sternotomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sachin Tanwar |
| Designation |
Pg Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anesthesia, Vmmc and Safdarjung Hospital, New Delhi, 110029
New Delhi
DELHI
110029
India |
| Phone |
7014660654 |
| Fax |
|
| Email |
tanwar98sachin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amita Gupta |
| Designation |
Professor and Consultant |
| Affiliation |
Vmmc and Safdarjung Hospital |
| Address |
Department of Anesthesia, Vmmc and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029
New Delhi
DELHI
110029
India |
| Phone |
9910382190 |
| Fax |
|
| Email |
amitaguptadr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amita Gupta |
| Designation |
Professor and Consultant |
| Affiliation |
Vmmc and Safdarjung Hospital |
| Address |
Department of Anesthesia, Vmmc and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029
New Delhi
DELHI
110029
India |
| Phone |
9910382190 |
| Fax |
|
| Email |
amitaguptadr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vmmc and Safdarjung hospital, Ansari Nagar , New Delhi,110010 |
|
|
Primary Sponsor
|
| Name |
Vmmc and Safdarjung Hospital |
| Address |
Vmmc and Safdarjung Hospital, Ansari Nagar, New Delhi,10010 |
| 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 Sachin Tanwar |
Vmmc and Safdarjung Hospital |
Dept of Anesthesia, vmmc and Safdarjung Hospital, Ansari Nagar, 110010
New Delhi
DELHI |
7014660654
tanwar98sachin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Intervention |
pectointercoastal fascial block |
Comparison between pecto intercostal fascial block with transversus thoracic plane block in post sternotomy patients. Ultrasound guided block will be given, patient will be placed in supine position, after proper sterilisation.Using the in plane technique 80mm nerve block needle will be advanced in plane between the pectoralis major and internal intercoastal muscles.
Drug : 20ml of 0.25 % Bupivacaine with 2mg of Dexamethasone will be injected in the interfascial plane .
Same will be performed on the opposite side . Ease of block will be assessed using a 5 point Likert scale.
Pt will be elective ventilated till hemodynamic parameters are within normal limits.Post operative pain will be assessed using Numerical rating Scale. |
| Comparator Agent |
Transverse thoracis plane block |
Comparison of pectointercoastal fascial block with transversus thoracic muscle plane block in post sternotomy patients, ultrasound guided block will be performed. Patient will be placed in supine position.
After proper sterilisation, 80mm nerve block needle will be placed in the plane between transverse thoracic muscle and internal intercostal muscle.
Drug : 20ml of 0.25 % Bupivacaine with 2 mg of Dexamethasone will be injected on both sides of sternum in sequence. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the American society of Anesthesiologist grade 2 and 3 , for elective cardiac surgery. |
|
| ExclusionCriteria |
| Details |
Contraindications for regional anesthesia.
Allergy to local anesthetic drugs.
History of chronic pain |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain score(numerical rating scale 0-10) |
At rest, 6 hrs,12hrs,24hrs and 48 hrs post op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain during cough, total opiod consumtion,number of rescue analgesia,ease of block performance. |
6,12,24,36,48 hrs post surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
25/09/2024 |
| 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 Yet Recruiting |
| 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
|
This study is prospective, interventional study to compare the effect of 2 blocks i.e transverse thoracis plane block with pectointercoastal fascial block in the patient’s undergoing cardiac surgery through midline sternotomy with a hypothesis that pectointercoastal fascial block is better than transverse thoracis plane block.Pain score will be performed at rest, 6 hrs ,12hrs,24 and 48hrs after surgery also the ease of block performance will be compared. |