| CTRI Number |
CTRI/2025/09/094433 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Efficacy of Erector Spinae Block vs Thoracic Paravertebral Block in Breast surgeries |
|
Scientific Title of Study
|
Comparison of Efficacy of USG guided Erector spinae block vs Thoracic Paravertebral block for peri-operative management of breast surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manikandan M |
| Designation |
Junior Resident |
| Affiliation |
Command hospital airforce Bangalore |
| Address |
Department of Anaesthesiology
Command hospital airforce Bangalore
Jogupalaya
Bangalore
KARNATAKA
560007
India |
| Phone |
8124089991 |
| Fax |
|
| Email |
manikandanmuni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avanish Bhardwaj |
| Designation |
Professor |
| Affiliation |
Command hospital airforce Bangalore |
| Address |
Department of Anaesthesiology,Command hospital airforce Bangalore
Bangalore
KARNATAKA
560007
India |
| Phone |
9914734466 |
| Fax |
|
| Email |
avanishbhardwaj78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manikandan M |
| Designation |
Junior Resident |
| Affiliation |
Command hospital airforce Bangalore |
| Address |
Department of Anaesthesiology, Command hospital airforce Bangalore
Bangalore
KARNATAKA
560007
India |
| Phone |
8124089991 |
| Fax |
|
| Email |
manikandanmuni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Command hospital airforce Bangalore, Jogupalaya, Bangalore, Karnataka, PIN-560007 |
|
|
Primary Sponsor
|
| Name |
Manikandan M |
| Address |
Department of Anaesthesiology, Command hospital airforce Bangalore , Jogupalaya, PIN-560007 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Manikandan M |
Operation theatre |
Command hospital airforce Bangalore, Jogupalaya
Bangalore
KARNATAKA |
8124089991
manikandanmuni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae block |
20ml of 0.25% Bupivacaine injected into Erector spinae plane for peri-operative management of breast surgeries for next 18 months |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Thoracic paravertebral block |
20ml of 0.25% Bupivacaine is injected into Thoracic Paravertebral plane for peri-operative management of breast surgeries for next 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Female patients undergoing breast surgeries, willing to participate in the study, more than 18 years of age, ASA I-III patients |
|
| ExclusionCriteria |
| Details |
Coagulopathy, bleeding disorders, local site infection, emergency breast surgeries, prior breast surgeries, allergic to local anaesthetic agent, pre existing chronic pain or opioid dependence, severe cardio respiratory diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Peri-operative pain management, reduction in opioid consumption, reduction in use of anaesthetic drugs and volatile anaesthetic agent |
Peri-operative pain management, reduction in opioid consumption for 24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/09/2025 |
| 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
|
Comparison of Efficacy of USG guided Erector spinae block vs Thoracic Paravertebral block for peri operative management of breast surgeries with the aim of comparing the peri operative pain management by VAS score and total consumption of opioids, time for the first rescue analgesia, reduction in the use of anaesthetic drugs and volatile agents will be compared |