| CTRI Number |
CTRI/2025/08/093598 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
24/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing two medicines Ropivacaine and Bupivacaine for pain relief after breast surgery using an ultrasound guided block |
|
Scientific Title of Study
|
A comparative study of 0.5 percentage Ropivacaine vs 0.25 percentage Bupivacaine for postoperative analgesia using ultrasound guided serratus anterior plane block for breast surgeries A prospective double blinded randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSathish Arjunan |
| Designation |
Post graduate |
| Affiliation |
Shri Sathya Sai Medical College And Research Institute |
| Address |
Department of Anesthesiology,
Shri Sathya Sai Medical College and Research Institute
Chengalpet Taluk,
Kancheepuram
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9080565420 |
| Fax |
|
| Email |
getsflysathish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagan G |
| Designation |
Associate Professor |
| Affiliation |
Shri Sathya Sai Medical College And Research Institute |
| Address |
Department of Anesthesiology,
Shri Sathya Sai Medical College and Research Insitute,
Ammapettai,
Chengalpet Taluk,
Kancheepuram
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9940623333 |
| Fax |
|
| Email |
drjagangovindasamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSathish Arjunan |
| Designation |
Post graduate |
| Affiliation |
Shri Sathya Sai Medical College And Research Institute |
| Address |
Department of Anesthesiology,
Shri Sathya Sai Medical College and Research Insitute,
Ammapettai,
Chengalpet Taluk,
Kancheepuram
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9080565420 |
| Fax |
|
| Email |
getsflysathish@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrSathish Arjunan |
| Address |
Block 44 2H,Cee Dee yes Chennaipattinam apartments,Ammapettai,
Chengalpet Taluk,
Kancheepuram |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DrSathish Arjunan |
shri sathya sai medical college and research institute |
Department of Anesthesiology,
Kancheepuram
TAMIL NADU |
9080565420
getsflysathish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA 1 And 2 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
serratus anterior plane block |
20ml 0.5 percent ropivacaine for group A and 0.25 percent bupivacaine for group B |
| Intervention |
serratus anterior plane block |
20ml 0.5 percent ropivacaine for group A and 0.25 percent bupivacaine for group B |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
Patient scheduled for elective breast surgeries.
|
|
| ExclusionCriteria |
| Details |
Patient who has local infection at local site.
Patient who are allergic to local anaesthestics.
Patient who are unable to comprehend the study protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration and quality of postoperative pain relief between 0.5 percentage Ropivacaine and 0.25 percentage Bupivacaine using an ultrasound guided serratus anterior plane block in breast surgery patients, measured by pain scores Visual analogue scale and time to first rescue analgesic. |
6 hour,12 hour,24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
22/09/2025 |
| 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="6"
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 will compare two local anesthetic drugs, 0.5 percentage Ropivacaine and 0.25 percentage Bupivacaine, given through an ultrasound guided serratus anterior plane block for pain relief after breast surgery. It is a prospective, randomized, double-blinded controlled trial. The primary aim is to evaluate and compare the duration and quality of postoperative analgesia between the two groups. Secondary outcomes include total rescue analgesic consumption, pain scores at various time points, side effects, and patient satisfaction. |