| CTRI Number |
CTRI/2025/06/089649 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Modified Pectoral Block with Bupivacaine 0.25% after breast surgeries |
|
Scientific Title of Study
|
Comparison of the Effectiveness of Bupivacaine with Dexmedetomidine versus Bupivacaine with Dexamethasone in Ultrasound Guided Modified Pectoral Block for Postoperative Analgesia in 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 Sciences |
| Address |
Department of anaesthesiology MIMS MANDYA
Mandya
KARNATAKA
Mandya
KARNATAKA
571401
India |
| Phone |
9448046220 |
| Fax |
|
| Email |
drkris66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna K |
| Designation |
Associate professor |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Department of anaesthesiology MIMS MANDYA
Mandya
KARNATAKA
KARNATAKA
571401
India |
| Phone |
9448046220 |
| Fax |
|
| Email |
drkris66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Srisathyabanu |
| Designation |
Post graduate |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Department of anaesthesiology MIMS MANDYA
Mandya
KARNATAKA
Mandya
KARNATAKA
571401
India |
| Phone |
9597780388 |
| Fax |
|
| Email |
srisathyabanu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mandya Institute of Medical Sciences Mandya Karnataka India 571401 |
|
|
Primary Sponsor
|
| Name |
Krishna K |
| Address |
Department of Anaesthesiology Mandya Institute of Medical Sciences 571401 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| V Srisathyabanu |
Department of Anaesthesiology Mandya Institute of Medical Sciences 571401 |
|
|
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 |
Department of Anaesthesiology 1st floor 3rd cross Guttal road , Maruthi nagar , Mandya
Mandya
KARNATAKA |
9448046220
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 |
Female |
| Details |
BMI of less than 35kg/m2 , patients undergoing breast surgeries |
|
| ExclusionCriteria |
| Details |
bleeding disorder
local infection |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the duration of post operative analgesia between bupivacaine 0.25% with dexamethasone 8mg versus bupivacaine 0.25% with dexmedetomidine 1mcg/kg |
30 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post Operative Complications |
30 hours |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
07/07/2025 |
| 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
|
This study is designed to compare the duration of post operative analgesia in patients undergoing breast surgeries using bupivacaine with dexamethasone and bupivacaine with dexmedetomidine |