| CTRI Number |
CTRI/2024/05/066703 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Pain relief after Erector Spinae plane block vs Pain relied after Serratus anterior plane blocking patients undergoing major breast surgery |
|
Scientific Title of Study
|
Postoperative analgesic efficacy of Erector Spinae Plane Block VS
Serratus Anterior Plane Block in patients undergoing 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 |
Divya Vincent |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Basement 2, room 3,
Department of Anaesthesiology,
Father Muller Medical College
KankanadyMangalore
Kankanady main road, Mangalore 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8971023187 |
| Fax |
|
| Email |
djrexvin@fathermuller.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya Vincent |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Basement 2, room3,
Department of Anaesthesiology
Father Muller Medical College,Kankanady
Mangalore
Kankanady main road, Mangalore 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8971023187 |
| Fax |
|
| Email |
djrexvin@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Divya Vincent |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Basement 2, room 3,
Department of Anaesthesiology
Father Muller Medical College
Kankanady
Mangalore
Kankanady main road, Mangalore 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8971023187 |
| Fax |
|
| Email |
djrexvin@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Father Muller Charitable Institutions (FMCI)
Kankanady, Mangalore
DK-575002
INDIA |
|
|
Primary Sponsor
|
| Name |
Father Muller Medical College |
| Address |
Kankanady main road, Mangalore 575002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Divya Vincent |
Father Muller Medical College |
Department of Anaesthesiology, Operation Theatre, Father Muller medical College,Kankanady Mangalore575002
Dakshina Kannada
KARNATAKA |
8971023187
djrexvin@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional ethics committee |
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 |
Erector spine plane block |
A local anaesthetic - 20 ml 0.25% bupivacaine is given in the t4-t5 erector spine plane for pain relief after breast surger |
| Intervention |
Serratus anterior block |
A local anaesthetic -20 ml 0.25% bupivacaine is given in the anterior Serratus plane for pain relief after breast surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
-American Society of Anaesthesiologists physical status I-IV |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients who are being treated with drugs that compromise the study
benzodiazepines and sedatives like lithium, opioids like morpine. - Pregnant women
- Patients with significant neurological or respiratory diseases
-Patients with BMI more than 40
- Local anesthetic allergy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| analgesic efficacy and safety profile between both groups |
postoperatively at 1 hour to 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Superiority of one block over the other |
12 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| Date of Study Completion (India) |
10/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Erector Spinae plane Block (ESPB) is a newer block that has been successfully used for many surgeries involving chest wall and is also useful for pain relief in rib fractures Its success in MRM has been documented For Radical surgeries like MRM, it is simple and convenient to administer blocks away from the surgical site. Serratus Anterior plane block (SAPB) is a relatively newer block which was primarily used for management of pain from rib fractures, there is potential for its use in MRM as an alternate when it is difficult to administer ESP block as the anterior branch of intercostal nerves lie under the serratus anterior muscle We plan to compare the analgesic efficacy of ESP with SAB , to determine the superiority of either , and the compare the ease of administration of the block. |