| CTRI Number |
CTRI/2022/10/046536 [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 |
Other |
|
Public Title of Study
|
To study the effect of ultrasound guided nerve block in providing pain relief in patients undergoing cardiac surgery. |
|
Scientific Title of Study
|
Effect of ultrasound guided transversus thoracis plane block on post operative analgesia in patients undergoing cardiac surgery through midline sternotomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lalthazuali |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir medical college and Safdarung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9626018245 |
| Fax |
|
| Email |
thazualijongte@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amita Gupta |
| Designation |
Professor and consultant |
| Affiliation |
Vardhman Mahavir medical college and Safdarjunget hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9910382190 |
| Fax |
|
| Email |
amitaguptadr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amita Gupta |
| Designation |
Professor and consultant |
| Affiliation |
Vardhman Mahavir medical college and Safdarjunget hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi
DELHI
110029
India |
| Phone |
9910382190 |
| Fax |
|
| Email |
amitaguptadr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Lalthazuali |
Vardhman Mahavir medical college and Safdarjung hospital |
Department of anaesthesia and Intensive care , Ansari Nagar, New Delhi
New Delhi
DELHI |
9626018245
thazualijongte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir medical college and Safdarjung hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
General anaesthesia with ultrasound guided Transversus thoracis plane block for post operative analgesia |
Adult patient undergoing cardiac surgery under general anaesthesia will be given ultrasound guided Transversus thoracis plane block pre operatively for post operative analgesia and pain score will be measured at 12 hrs and 24hrs after surgery |
| Comparator Agent |
Only general anaesthesia |
Adult patient undergoing cardiac surgery will be induced under general anaesthesia and pain score will be measured after 12hrs and 24hrs post surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists Grade II and III posted for cardiac surgery necessitating midline sternotomy |
|
| ExclusionCriteria |
| Details |
1. Patients with contraindication for regional anaesthesia
2. Allergy to local anaesthetic drugs
3. History of chronic pain
4. Inability to communicate effectively/psychiatric illness
5. Patients who had been intubated for more than 24hrs prior to surgery
6. Standard high risk patients based on Euroscore II |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of preoperative transversus thoracis plane block on postoperative analgesia during rest, during cough and during spirometry using Numerical Rating System in adult undergoing cardiac surgery through midline sternotomy |
To evaluate the effect of preoperative transversus thoracis plane block on postoperative analgesia during rest, during cough and during spirometry using Numerical Rating System in adult undergoing cardiac surgery through midline sternotomy at 12hrs and 24hrs post surgery |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. Postoperative respiratory function
2. Total opioid consumption in the first 24 hrs after surgery
3. Number of rescue analgesia in the first 24 hrs after surgery
4. Duration of mechanical ventilation |
Respiratory function will be measured by ultrasound guided diaphragmatic excursion at 12 hrs and 24hrs after surgery along with ABG which will be taken at 6hrs, 12hrs and 24hrs after surgery |
|
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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)
|
21/10/2022 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective, interventional, comparative randomized study to evaluate the effect of ultrasound guided Transversus thoracis plane block on post operative analgesia in patients undergoing cardiac surgery through midline sternotomy under general anaesthesia, with the hypothesis that preoperative transversus thoracis plane block improves postoperative analgesia in patients undergoing cardiac surgery through midline sternotomy . Primary, postoperative pain score (NAS) will be recorded at 6 hrs, 12 hrs and 24hrs post surgery. Secondarily, postoperative respiratory function, total opioid consumption in 24hrs post surgery , number of rescue analgesia in 24hrs post surgery and duration of mechanical ventilation will be recorded. |