| CTRI Number |
CTRI/2022/07/044495 [Registered on: 29/07/2022] Trial Registered Prospectively |
| Last Modified On: |
25/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Continuous catheter Transverses thoracis muscle plane block in both side in median sternotomy |
|
Scientific Title of Study
|
Analgesic effect of Continuous Bilateral Transverses thoracis muscle plane block in median sternotomy : A Randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poonam Kumari |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences-Patna |
| Address |
Department of Anaesthesiology, Room No-506,5th Floor, OT complex, AIIMS Patna.
Patna
BIHAR
801507
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Kumari |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences-Patna |
| Address |
Department of Anaesthesiology, Room No-506,5th Floor, OT complex, AIIMS Patna.
Patna
BIHAR
801507
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Kumari |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences-Patna |
| Address |
Department of Anaesthesiology, Room No-506,5th Floor, OT complex, AIIMS Patna.
Patna
BIHAR
801507
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology, Aiims Patna |
|
|
Primary Sponsor
|
| Name |
Department Of AnaesthesiologyAiims Patna |
| Address |
Department of Anaesthesiology,5th floor OT complex ,Aiims Patna |
| 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 Poonam Kumari |
Aiims Patna |
Ot complex, 6th floor ,Aiims Patna
Patna
BIHAR |
9473199126
drpoonam1981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I278||Other specified pulmonary heart diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group I: intravenous fentanyl |
Group I: will receive Intravenous fentanyl after completion of surgery |
| Comparator Agent |
Group II:TTP Block |
Group II: will receive TTP Block after completion of surgery |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA I/II
2.Age – 17 to 65years
3.Scheduled for Lung surgery via median sternotomy
|
|
| ExclusionCriteria |
| Details |
1.ASA physical status > Grade III
2.Allergic to local anesthetics
3.Local infection at or near the needle insertion site
4.Severe respiratory compromise
5.Coagulopathy or medical anticoagulation
6.Mental disorder
• Communication failure
• Inability to understand the functionality of patient-controlled analgesia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| postoperative analgesics (total dose of Fentanyl) in 24 hours . |
postoperative analgesics (total dose of Fentanyl) in 24 hours . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time of first rescue analgesia
2. NRS score post operative period at 30 min,2 hour,4 hour,8 hour,12 hour,24 hour
3. Length of ICU stay
4. Adverse effect
|
30 min,2 hour,4 hour,8 hour,12,hour,24 hour |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
02/08/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The management of postoperative pain after sternotomy is a challenging one. we aim to evaluate the analgesic effect of USG guided TTP block in reducing the post-operative (24 hours) opioid consumption in patient undergoing Median Sternotomy. |