| CTRI Number |
CTRI/2022/10/046529 [Registered on: 17/10/2022] Trial Registered Prospectively |
| Last Modified On: |
15/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Bilateral Transversus Thoracic Plane Block to reduce postoperative opioid consumption in first 24 hours after Cardiac Surgeries Through Midline Sternotomy . |
|
Scientific Title of Study
|
Efficacy of Bilateral Transversus Thoracic Plane Block with Dexmedetomidine Adjuvant on Post-Operative Opioid Consumption After Cardiac Surgeries Through Midline Sternotomy - A Prospective Randomised, Controlled, Observer Blind Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PRAVEEN |
| Designation |
Junior Resident |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
4TH FLOOR,NEHRU HOSPITAL,DEPT OF ANAESTHESIA AND INTENSIVE CARE, PGIMER.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7206652666 |
| Fax |
|
| Email |
praveendhouchak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Kulbhushan saini |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
4TH FLOOR,NEHRU HOSPITAL,DEPT OF ANAESTHESIA AND INTENSIVE CARE, PGIMER.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9968856948 |
| Fax |
|
| Email |
kulbhushansaini007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRAVEEN |
| Designation |
Junior Resident |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
4TH FLOOR,NEHRU HOSPITAL,DEPT OF ANAESTHESIA AND INTENSIVE CARE, PGIMER.
CHANDIGARH
160012
India |
| Phone |
7206652666 |
| Fax |
|
| Email |
praveendhouchak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia PGIMER Chandigarh |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
INSTITUTIONAL ETHICS COMMITTEE, PGIMER, CHANDIGARH |
| Type of Sponsor |
Research institution |
|
|
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 PRAVEEN |
PGIMER CHANDIGARH |
CTVS OT Complex, ADVANCED CARDIAC CENTRE, Department of Anesthesia
Chandigarh
CHANDIGARH |
7206652666
praveendhouchak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,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: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional analgesia. |
Only conventional analgesia (No Regional Muscle plane block). |
| Intervention |
Transversus thoracic muscle plane Block |
USG guided-TTP block bilaterally in supine position with 0.2% Ropivacaine with adjuvant 1mcg/kg Dexmedetomidine based on weight after institution of general anesthesia (20 ml total drug volume on each side). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA PHYSICAL STATUS I/II |
|
| ExclusionCriteria |
| Details |
1. Patient with preoperative ejection fraction <35%
2. Low-cardiac-output syndrome
3. Recurrent ventricular arrhythmias
4. Preoperative inotropic support
5. Allergic to local anesthetics (LA)
6. Re-exploration or emergency surgery
7. Spinal deformity
8. Local infection
9. Psychiatric illness
10. Neurological deficit
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess and Compare the cumulative postoperative analgesic (fentanyl dose) requirement |
In first 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| time to first rescue analgesia |
In 24 hours |
| Extubation time after surgery |
(IN MINUTES) |
| total Intraoperative fentanyl consumption requirement. |
After Incision to Till 24 HRS |
| Assess and compare 11-point NRS |
0,2,4,6,9,12,18 and 24 hours postoperatively. |
| Ramsay sedation score |
6 hours postoperatively |
| duration of ICU stay and length of hospital stay |
Till Discharge from icu and hospital. |
| the incidence of PONV, Pruritis, Other Complications. |
In 24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
17/10/2022 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Probably after the trial is completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Transverse thoracic block is a new analgesic method for post- sternotomy discomfort. This study will asses the efficacy of an ultrasound-guided transversus thoracic muscle plane block (TTPB) in patients undergoing heart surgery, including sternotomy. |