| CTRI Number |
CTRI/2024/04/065595 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Duration of post operative analgesia in patients undergoing unilateral breast surgeries with bupivacaine plus adjuvants |
|
Scientific Title of Study
|
A Comparative Study of Bupivacaine with Dexmedetomidine versus Bupivacaine with Dexamethasone in Ultrasound Guided Serratus Anterior Plane Block for Post Operative Analgesia in Unilateral 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 Krishna K |
| Designation |
associate professor |
| Affiliation |
Mandya Institute of Medical Science |
| Address |
hospital building 1st floor Department of anaesthesiology MIMS Mandya
Mandya
KARNATAKA
571401
India
Mandya
KARNATAKA
571401
India |
| Phone |
09448046220 |
| Fax |
|
| Email |
drkris66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna K |
| Designation |
associate professor |
| Affiliation |
Mandya Institute of Medical Science |
| Address |
Hospital building 1st floor Department of anaesthesiology MIMS Mandya
Mandya
KARNATAKA
571401
India
Mandya
KARNATAKA
571401
India |
| Phone |
9448046220 |
| Fax |
|
| Email |
drkris66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna K |
| Designation |
associate professor |
| Affiliation |
Mandya Institute of Medical Science |
| Address |
Hospital building 1st floor Department of anaesthesiology MIMS Mandya
Mandya
KARNATAKA
571401
India
Mandya
KARNATAKA
571401
India |
| Phone |
09448046220 |
| Fax |
|
| Email |
drkris66@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hospital building 1st floor Department of anaesthesiology MIMS Mandya
Mandya
KARNATAKA
571401
India |
|
|
Primary Sponsor
|
| Name |
Krishna K |
| Address |
Associate professor Department of anaesthesiology MIMS Mandya |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Bhavyashree G Y |
Assistant professor Department of anaesthesiology MIMS Mandya |
| Dr shashikumar P |
Post graduate student
Department of anaesthesiology MIMS Mandya |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krishna K |
Mandya Institute of Medical Sciences |
Hospital building 1st floor Department of anaesthesiology MIMS Mandya
Mandya
KARNATAKA
571401
India
Mandya
KARNATAKA |
09448046220
drkris66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE , MANDYA INSTITUTE OF MEDICAL SCIENCES |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing elective unilateral breast surgeries, asa grade I and II |
|
| ExclusionCriteria |
| Details |
patients allergic to local anaesthetic , diabetic, bleeding disorder, local infection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of postoperative analgesia between bupivacaine 0.25% with dexmedetomidine 50 micro gram with dexamethasone 4mg in unilateral breast surgeries |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| complication of nausea and vomiting |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
30/04/2024 |
| 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 - NO
|
|
Brief Summary
|
The purpose of the study is to compare the duration of postoperative analgesia between bupivacaine 0.25% with dexmedetomidine versus bupivacaine 0.25% with dexamethasone in unilateral breast surgeries |