| CTRI Number |
CTRI/2025/03/081759 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to examine and compare the effectiveness of using two different medications for reducing pain after breast cancer operation and also study the pain free time period after the injection. |
|
Scientific Title of Study
|
A prospective randomised study comparing the efficacy of 0.25 % bupivacaine and 0.25% levobupivacaine in pectoral nerve type 2 block for postoperative pain relief in patients undergoing elective modified radical mastectomy |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Radhika G S |
| Designation |
Post graduate |
| Affiliation |
Mysore medical college and research institute |
| Address |
Mysore medical college and research institute
2nd floor, Department of Anaesthesiology, New Stone building, KR Hospital, irwin road, Mysore, Karnataka
Mysore
KARNATAKA
571603
India |
| Phone |
8073934949 |
| Fax |
|
| Email |
radhikags666@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DEEPA KATTISHETTAR |
| Designation |
Associate professor |
| Affiliation |
Mysore medical college and research institute |
| Address |
Mysore medical college and research institute
2nd floor, Department of Anaesthesiology, New Stone building, KR Hospital, irwin road, Mysore, Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
9611104343 |
| Fax |
|
| Email |
deepapalax@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DEEPA KATTISHETTAR |
| Designation |
Associate professor |
| Affiliation |
Mysore medical college and research institute |
| Address |
Mysore medical college and research institute
2nd floor, Department of Anaesthesiology, New Stone building, KR Hospital, irwin road, Mysore, Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
9611104343 |
| Fax |
|
| Email |
deepapalax@gmail.com |
|
|
Source of Monetary or Material Support
|
| KR Hospital, irwin road, devaraja mohalla, yadavagiri, mysore, karnataka 570001 |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology |
| Address |
2nd floor, New stone building, K R Hospital, Mysore medical college and research institute, Mysore, karnataka 570001 |
| 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 Radhika G S |
Mysore medical college and research institute, |
2nd floor, Department of Anaesthesiology, New Stone building, irwin road, KR Hospital Mysore medical college and research institute, Mysore, Karnataka
Mysore
KARNATAKA |
8073934949
radhikags666@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics Commitee, Mysore medical college and research institute and associated hospitals, Mysore |
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 |
Group 1 |
patients will recieve 0.25% bupivacaine after skin closure
and efficacy of drug is assessed till 24hours after surgery |
| Comparator Agent |
Group 2 |
patients will recieve 0.25% levobupivacaine after skin closure
and efficacy of drug is assessed till 24hours after surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
All patients of ASA grade I and grade II patients between 18 to 65yrs |
|
| ExclusionCriteria |
| Details |
1]patient refusal to the procedure
2]any contraindications for regional anaesthesia technique like infection at the site of injection
3]coagulation disorder
4]drug allergy
5]history of other cancer
6]history of previous breast surgery
7]ASA grade IV
8]respiratory disease, cardiac disease and renal disease
9]having chemotherapy or radiotherapy in recent 8 weeks |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparing the efficacy of 0.25% bupivacaine and 0.25% levobupivacaine in Carcinoma breast surgeries using PEC 2 block and the duration of postoperative analgesia |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| total rescue analgesia required in the first 24hrs |
24hrs |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/03/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 a prospective randomised study comparing the efficacy of 0.25% bupivacaine and 0.25% levobupivacaine in PEC 2 block for postoperative pain relief in patients undergoing elective modified radical mastectomy surgery and to study the duration of postoperative analgesia |