| CTRI Number |
CTRI/2025/05/087076 [Registered on: 19/05/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy comparision of bupivacain vs ropivacain in midpoint transverse process to pleura block in modified radical mastectomy surgeries |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of Bupivacain and Ropivacain in Midpoint Transverse process to pleura block for 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 |
Dr Himanshu dubey |
| Designation |
PG Resident |
| Affiliation |
Pt JNM Medical Collge Raipur CG |
| Address |
Departnent of Anaesthesiology and Pain Medicine Pt JNM Medical College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9165783431 |
| Fax |
|
| Email |
himanshu20192@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaya Lalwani |
| Designation |
Proffesor |
| Affiliation |
Pt JNM Medical College Raipur CG |
| Address |
Department of Anaesthesiology and Pain Medicine Pt JNM Mdical College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9300224989 |
| Fax |
|
| Email |
jayalalwani2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himanshu Dubey |
| Designation |
PG Resident |
| Affiliation |
Pt JNM Medical College Raipur CG |
| Address |
Department of Anaesthesiology and Pain Medicine Pt JNM Mdical College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9165783431 |
| Fax |
|
| Email |
himanshu20192@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Pain Medicine, Pt JNM Medical College Raipur,Chhattisgarh, India PIN CODE -492001 |
|
|
Primary Sponsor
|
| Name |
Pt JNM Medical College Raipur CG |
| Address |
Department of Anaesthesiology and Pain Medicine, Pt JNM Medical College Raipur, Opposit jail road , Raipur Chhattisgarh, India Pin Code 492001 |
| 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 Himanshu Dubey |
Dr Bhimrao Ambedakar Memorial Hospital ,Raipur Chhattisgarh |
Oncosurgery and General Surgery OT, Room No. 1 and 2 , Department of Anaesthesiology and Pain Medicine Raipur CHHATTISGARH
Raipur
CHHATTISGARH |
9165783431
himanshu20192@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Pt LNM Medical College Raipur CG |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, , (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Midpoint transverse process to pleura block in MRM Surgeries |
0.5% Ropivacaine or 0.25% Bupivacaine, 10ml deposited above costo transverse ligament at each T2,T3 and T5 level , preinduction |
| Comparator Agent |
Post operative analgesia after modified radical mastectomy surgeries. |
USG guided local anesthetic drug injection will be given over superior costo transverse ligament at T2 , T3 and T5 level |
| Comparator Agent |
Post operative analgesia after modified radical mastectomy surgeries. |
USG guided local anesthetic drug injection will be given over superior costo transverse ligament at T2 , T3 and T5 level |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA Grade 1 and 2 patients scheduled for elective MRM surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patient with COPD and lung disease
Patient with severe liver disease
Obesity with BMI more than 31
Patient on any analgesics
Local site infections
Local injury
Allergic to study drugs |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post surgical analgesia using VAS score,as first rescue analgesic requirements. |
Post surgical analgesia using VAS score at 0,2,4,8,10,12,16,20,24 and 48 hours, with Blood pressure, Heart rate, and SpO2 saturation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction evaluated using, Likert scale |
Liberty scale at 0,4,8,12,24 and 48 hours |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
20/05/2025 |
| 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 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 is a randomized Interventional study comparing two drugs I.e. inj. Ropivacaine 0.5% and inj. Bupivacaine 0.25% via midpoint transverse process to pleura block in patients undergoing modified radical mastectomy surgeries in terms of post surgical analgesic efficacy. Patients will be enrolled with a sample size of 128 ( 64 in each group) , primary outcome will be first rescue analgesia duration using VAS score. Secondary outcome will be patient satisfaction using Likert score . |