| CTRI Number |
CTRI/2021/01/030727 [Registered on: 25/01/2021] Trial Registered Prospectively |
| Last Modified On: |
01/02/2021 |
| 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
|
Local Anaesthetic injection near spinal cord for breast cancer surgery . |
|
Scientific Title of Study
|
Single Needle Thoracic Paravertebral Block As An Alternative To General Anaesthesia For Modified Radical Mastectomy Operation - A Randomised Controlled Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARCHANA ROY |
| Designation |
ASSISTANT PROFESSOR ANAESTHESIOLOGY |
| Affiliation |
NIL RATAN SIRCAR MEDICAL COLLEGE & HOSPITAL |
| Address |
Department of Anaesthesiology
138 ACHARYA JAGADISH CHANDRA BOSE ROAD KOLKATA
Kolkata
WEST BENGAL
700004
India |
| Phone |
8910156423 |
| Fax |
|
| Email |
roy.archana1234567@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ARCHANA ROY |
| Designation |
ASSISTANT PROFESSOR ANAESTHESIOLOGY |
| Affiliation |
NIL RATAN SIRCAR MEDICAL COLLEGE & HOSPITAL |
| Address |
Department of Anaesthesiology
138 ACHARYA JAGADISH CHANDRA BOSE ROAD KOLKATA
Kolkata
WEST BENGAL
700004
India |
| Phone |
8910156423 |
| Fax |
|
| Email |
roy.archana1234567@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ARCHANA ROY |
| Designation |
ASSISTANT PROFESSOR ANAESTHESIOLOGY |
| Affiliation |
NIL RATAN SIRCAR MEDICAL COLLEGE & HOSPITAL |
| Address |
Department of Anaesthesiology
138 ACHARYA JAGADISH CHANDRA BOSE ROAD KOLKATA
Kolkata
WEST BENGAL
700004
India |
| Phone |
8910156423 |
| Fax |
|
| Email |
roy.archana1234567@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIL RATAN SIRCAR MEDICAL COLLEGE AND HOSPITAL |
|
Primary Sponsor
Modification(s)
|
| Name |
Nil Ratan Sircar Medical College |
| Address |
138, Acharya Jagadish Chandra Bose Road, Kolkata, West Bengal |
| 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 Archana Roy |
NIL RATAN SIRCAR MEDICAL COLLEGE HOSPITAL |
Department of Anaesthesiology,NRSMCH, 138 A.J.C. BOSE ROAD
Kolkata
WEST BENGAL |
8910156423
roy.arcahna1234567@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NRS MEDICAL COLLEGE & HOSPITAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General Anaesthesia |
General Anaesthesia given with endotracheal intubation. |
| Intervention |
Thoracic Paravertebral Block |
Thoracic Paravertebral Block given at T4 vertebral level using Tuohy needle and local anaesthetic Bupivaicaine 0.5% injected via epidural catheter. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Female patients with carcinoma breast posted for Modified Radical Mastectomy operation |
|
| ExclusionCriteria |
| Details |
Local site infection
ASA grade 3 or more
Drug Allergy
Bleeding disorder
BMI more than 35 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total opioid requirement for post operative analgesia |
24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of post operative analgesia |
24hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/01/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Thoracic Paravertebral Block to be given at T4 level using Tuohy needle and local anaesthetic Bupivaicaine 0.5% up to 20ml will be given through epidural catheter. Intraoperative dexemedetomidine infusion will be given. Intraoperative and postoperative analgesic efficacy will be compared with General Anaesthesia patients. |