| CTRI Number |
CTRI/2019/03/018002 [Registered on: 08/03/2019] Trial Registered Prospectively |
| Last Modified On: |
02/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two drugs for surgical pain relief in breast surgeries |
|
Scientific Title of Study
|
COMPARISON BETWEEN BUPIVACAINE AND ROPIVACAINE IN THORACIC EPIDURAL ANAESTHESIA FOR MODIFIED RADICAL MASTECTOMY – A RANDOMISED CONTROLLED TRIAL’
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ASWINI L |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
ESIC MEDICAL COLLEGE AND PGIMSR |
| Address |
ESIC MEDICAL COLLEGE AND PGIMSR KK NAGAR CHENNAI
TAMIL NADU 600078
Dept
of Anaesthesiology ESI PGIMSR KK NAGAR Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9442011352 |
| Fax |
- |
| Email |
aswinijipmer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASWINI L |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
ESIC MEDICAL COLLEGE AND PGIMSR |
| Address |
ESIC MEDICAL COLLEGE AND PGIMSR KK NAGAR CHENNAI
TAMIL NADU 600078
Dept
of Anaesthesiology ESI PGIMSR KK NAGAR Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9442011352 |
| Fax |
- |
| Email |
aswinijipmer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ASWINI L |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
ESIC MEDICAL COLLEGE AND PGIMSR |
| Address |
ESIC MEDICAL COLLEGE AND PGIMSR KK NAGAR CHENNAI
TAMIL NADU 600078
Dept
of Anaesthesiology ESI PGIMSR KK NAGAR Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9442011352 |
| Fax |
- |
| Email |
aswinijipmer@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC MEDICAL COLLEGE AND PGIMSR
ASHOK PILLAR ROAD
KK NAGAR
CHENNAI 600078 |
|
|
Primary Sponsor
|
| Name |
ESIC MEDICAL COLLEGE |
| Address |
ESIC MEDICAL COLLEGE
KK NAGAR
CHENNAI
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 ASWINI L |
ESIC MEDICAL COLLEGE AND HOSPITAL KK NAGAR CHENNAI |
DEPT OF ANAESTHESIOLOGY
ROOM NO 106, FIRST FLOOR ,OLD BUILDING (A BLOCK),
ESIC MEDICAL COLLEGE AND PGIMSR HOSPITAL
ASHOK PILLAR ROAD
KK NAGAR
CHENNAI 600078
Chennai
TAMIL NADU |
9442011352
-
aswinijipmer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee -ESIC MEDICAL COLLEGE |
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 |
| Comparator Agent |
THORACIC EPIDURAL
BUPIVACAINE 0.5% |
LOCAL ANAESTHETIC GIVEN VIA EPIDURAL CATHETER |
| Intervention |
THORACIC EPIDURAL
ROPIVACAINE 0.5% |
LOCAL ANAESTHETIC GIVEN VIA EPIDURAL CATHETER |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Age 18 to 70 years
2. ASA physical status I and II
3. Patients with informed written consent
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patients with known history of allergy to local anaesthetics
3. Patients with local site infection
4. Patients with coagulopathy or bleeding disorders
5. Patients with severe spinal deformity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the intra operative hemodynamics between 0.5 % bupivacaine and 0.5%ropivacine when when used in thoracic epidural for modified radical mastectomy. |
Intraoperatively every 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the analgesia provided by 0.5 % bupivacaine and 0.5% ropivacine when used as a continuous epidural infusion in the post operative period for modified radical mastectomy.
|
Post operatively every 4 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2019 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a study to compare two local anaesthetics when given via epidural catheter for modified radical mastectomies. Our aim is to compare the hemodyanmics and post operative pain between the two drugs. |