| CTRI Number |
CTRI/2024/07/071679 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
To evaluate the effect of local anaesthetic in breast surgeries |
|
Scientific Title of Study
|
Evaluation and efficacy of tumescent anesthesia in
simple 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 |
Dr Brindha R |
| Designation |
Professor and Head of Department |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9443247021 |
| Fax |
|
| Email |
mskbrins63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Naveena |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9486198407 |
| Fax |
|
| Email |
naveenasen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G John Peter |
| Designation |
Post Graduate Resident |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem
Salem
TAMIL NADU
636308
India |
| Phone |
7401623307 |
| Fax |
|
| Email |
gjohnpeter1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem Tamil Nadu 636308 India |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem 636308 Tamil Nadu India |
| Type of Sponsor |
Private 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 G John Peter |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
Room Number 15 Department of Anaesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem
Salem
TAMIL NADU |
7401623307
gjohnpeter1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Evaluating the efficacy of local anaesthetic |
Evaluating the efficacy of tumescent anaesthetic solution consisting of Lignocaine 2% 20 ml, Ropivacaine 0.75% 20 ml, Adrenaline 1:1000 1 ml, Soda bicarbonate 2ml, Hyaluronidase 1500 IU for simple breast surgeries |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA Grade 1 & 2
2. Age not less than 15 years and not more than 50 years
3. Elective surgeries
4. Operable breast surgeries
5. Patient giving valid informed consent |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. ASA Grade 3 & 4
3. Age less than 15 years and more than 50 years
4. Carcinoma breast
5. Local infection at puncture site
6. Patient with ischaemic and rheumatic heart diseases
7. Patient with coagulation defects and on anti coagulants
8. Patients with neuromuscular disorder
9. Patients allergic to local anaesthetic drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of surgical anaesthesia for simple breast surgeries using tumescent technique |
2 to 4 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the post operative analgesic duration of anaesthesia |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
16/08/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - -
- For how long will this data be available start date provided 10-07-2024 and end date provided 30-07-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
To evaluate the efficacy of Tumescent anaesthesia in simple breast surgeries in terms of surgical anaesthesia efficacy and post operative analgesic duration by using tumescent solution containing Ropivacaine, Lignocaine, Adrenaline, Soda bicarbonate, Hyaluronidase for simple breast surgeries. |