| CTRI Number |
CTRI/2024/08/072372 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
comparison between erector spinae and paravertebral block for post operative pain in patients undergoing breast surgeries |
|
Scientific Title of Study
|
Comparison between ultrasound guided erector spinae plane block and ultrasound guided paravertebral block for post operative analgesia in breast surgeries- a randomised controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swathi S |
| Designation |
Junior Resident |
| Affiliation |
ESIC Medical college and PGIMSR |
| Address |
Department of Anaesthesiology
ESICMC AND PGIMSR
Rajajinagar Bangalore
Bangalore
KARNATAKA
560010
India |
| Phone |
9447188599 |
| Fax |
|
| Email |
swathi2shivam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak R |
| Designation |
Associate Proffesor |
| Affiliation |
ESIC Medical College and PGIMSR |
| Address |
2nd Floor OT Complex, Department of Anaesthesiology, ESIC MC and PGIMSR, Rajajinagar, Bangalore
Bangalore
KARNATAKA
560010
India |
| Phone |
9566216820 |
| Fax |
|
| Email |
deepakrkarnataka@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak R |
| Designation |
Associate professor |
| Affiliation |
ESIC Medical College and PGIMSR |
| Address |
2nd Floor OT Complex, Department of Anaesthesiology, ESIC MC and PGIMSR, Rajajinagar, Bangalore
Bangalore
KARNATAKA
560010
India |
| Phone |
9566216820 |
| Fax |
|
| Email |
deepakrkarnataka@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESICMC And PGIMSR Rajajinagar
Bangalore 560010 |
|
|
Primary Sponsor
|
| Name |
DR SWATHI S |
| Address |
ESICMC And PGIMSR Rajajinagar Bangalore 560010 |
| 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 |
| Dr Swathi S |
ESICMC And PGIMSR |
ESICMC And PGIMSR Rajajinagar Bangalore 560010
Bangalore
KARNATAKA |
9447188599
swathi2shivam@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: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
comparison between erector spinae and paravertebral block |
comparison between ultrasound guided erector spinae plane block and ultrasound guided paravertebral block in breast surgeries for 24 hours |
| Comparator Agent |
comparison between usg guided erector spinae block and usg guided paravertebral block |
comparison between usg guided erector spinator block and usg guided paravertebral block for post operative analgesia in breast surgeries |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient wiiling to give informed written consent
ASA 1 and ASA 2 |
|
| ExclusionCriteria |
| Details |
Patient not willing to give informed written consent
Heart block more than 1st degree
pregnancy and lactation
Coagulation disorders
Body Mass Index more than 35kg/m2
Patients who have known allergy to local anesthetics
Heart block greater than 1st degree |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the postoperative pain score using Numerical Rating Scale at 12 hours |
To compare the postoperative pain score using Numerical Rating Scale at 12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The time to first analgesic request
2.To compare the overall consumption of opiod{Nalbuphine} in 24 hours |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
28/08/2024 |
| 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 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 between ultrasound guided erector spinae plane block and ultrasound guided paravertebral block for post operative analgesia in breast surgeries as breast malignancy is the most common malignancy in female, which accounts for 25% of all cancers in women. one of the main treatments for it is modified radical mastectomy and acute pain following breast surgery, however may result in extended hospital stay, delayed ambulation, patient discomfort. Regional anaesthesia can reduce the requirement for analgesic and anaesthetic modifications during and result in better patient outcome |