| CTRI Number |
CTRI/2017/02/007897 [Registered on: 16/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
06/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two types of anaesthesia "nerve blocks in breast cancer surgery |
|
Scientific Title of Study
|
A study on pain and quality of life among women after breast surgery and comparison of two techniques of analgesia. |
| Trial Acronym |
BUGS ( Breast surgery under Ultrasound, non Opioid) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swagata Tripathy |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Dept of Anesthesia & Intensive Care,
AIIMS,
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
8763400534 |
| Fax |
|
| Email |
tripathyswagata@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swagata Tripathy |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Dept of Anesthesia & Intensive Care,
AIIMS,
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
tripathyswagata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swagata Tripathy |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Dept of Anesthesia & Intensive Care,
AIIMS,
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
tripathyswagata@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bhubaneswar Intramural grant |
| Address |
Bhubaneswar |
| 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 Swagata Tripathy |
All India Institute of Medical Sciences, Bhubaneswar |
Dr Swagata Tripathy
Associate Professor
Dept. Anesthesia & Instensive Care
Room 406
Academic Block
Khordha
ORISSA |
8763400534
8763400534
tripathyswagata@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS BHubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Breast Lump, (1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
USG guided Paravertebral block PVB |
Nerve block of the paravertebral nerves |
| Intervention |
USG guided Pectoral (PECs ) block |
nerve block of pectoralis major and minor nerves |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients undergoing breast surgery ( MRM) |
|
| ExclusionCriteria |
| Details |
Allergy to LA agent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality and duration of analgesia |
Need for opiate rescue, Duration to first request for (non opiate analgesic), VAS scores for first 24 hours post surgery pain scores will be assessed at 0, 30 min, 1 hr, 2 hr and 2nd hrly thereafter at rest and on arm movement.
the total amount of analgesic consumed at end of 24 hrs post op will be assessed . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Complications of Block
Opioid REquirement
Quality of life on post operative follow up ( Chronic pain) |
QOL- 3 months and 6 months post op |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="58" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Tripathy, Swagata, et al. "Opioid-free anesthesia for breast cancer surgery: a comparison of ultrasound guided paravertebral and pectoral nerve blocks. A randomized controlled trial." Journal of Anaesthesiology, Clinical Pharmacology 35.4 (2019): 475. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To Compare block characteristics, complications and quality of life in patients undergoing breast surgery under usg guided nerve block. The patients will be given nerve block under sedation and spontaneous ventilation, with avoidance of opioid medications. |