| CTRI Number |
CTRI/2024/01/061422 [Registered on: 12/01/2024] Trial Registered Prospectively |
| Last Modified On: |
31/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study for post operative analgesic efficacy in breast carcinoma surgery patients |
|
Scientific Title of Study
|
USG guided Erector Spinae block versus local infiltration during breast surgery with General Anaesthesia- A comparative study of analgesic effect post operatively A double blinded Randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
John Magesh |
| Designation |
Assistant Professor |
| Affiliation |
Armed Forces Medical College Pune |
| Address |
Department of Anaesthesiology and Critical Care Armed Forces Medical College Pune. 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
9765167438 |
| Fax |
|
| Email |
majjohnmk9090@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
John Magesh |
| Designation |
Assistant Professor |
| Affiliation |
Armed Forces Medical College Pune |
| Address |
Department of Anaesthesiology and Critical Care Armed Forces Medical College Pune. 411040
MAHARASHTRA
411040
India |
| Phone |
9765167438 |
| Fax |
|
| Email |
majjohnmk9090@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
John Magesh |
| Designation |
Assistant Professor |
| Affiliation |
Armed Forces Medical College Pune |
| Address |
Department of Anaesthesiology and Critical Care Armed Forces Medical College Pune. 411040
MAHARASHTRA
411040
India |
| Phone |
9765167438 |
| Fax |
|
| Email |
majjohnmk9090@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care. AFMC Pune |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College. Pune |
| Address |
Department of Anaesthesiology and Critical Care. AFMC Pune. Pin 411040 |
| 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 |
| John Magesh |
Armed Forces Medical College Pune |
Department of Anaesthesiology and Critical Care AFMC Pune
Pune
MAHARASHTRA |
9765167438
majjohnmk9090@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional |
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 |
| Intervention |
Erector Spinae Plane Block (Group A) One-time bolus |
Patient in this group will recieve USG guided erector Spinae plane block (one time bolus) at the end of surgery just before extubation.
1). The patient would be in lateral decubitus position with the surgical side superiorly.
2). Under all aseptic precautions, ESPB would be performed at T4,T5 on the surgical side with high frequency linear USG probe.
3). The block will be managed by using a 22 gauge 50mm echogenic needle and 20 ml of 0.25% Bupivacaine will be injected as a single shot bolus injection. |
| Comparator Agent |
Local Infiltration (Group B)- single shot. |
At the end of surgery, the operating surgeon would be infiltrating the surgical field with 0.25% Bupivacaine (7.5ml) before closure, under direct vision.
1). 2.5ml of Inj Bupivacaine 0.25% each will be administered around the medial pectoral nerve, latissmus dorsi and nerve to serratus anterior. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1). American society of anaesthesiologists- Physical standards classification (ASA-PS) class II And class III individuals. |
|
| ExclusionCriteria |
| Details |
1).Patient refusal
2).Age below 18 years and above 65 years
3).ASA-PS Class IV and above
4).Patient with known allergies to any drugs used
5).Local Infection at the site of block
6).Patients receiving opioids for chronic analgesic therapy
7).Inability to comprehend Visual Analogue scale |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Analgesia and request for rescue analgesia |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue score of pain and incidence of post operative nausea and vomiting |
Time frame of 2 hours 4 hours 6 hours 12 hours ad 24 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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
|
None Yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
With the increase in prevalence of breast cancers as per the present lifestyle of Populace. Analgesic efficacy of present and novel modalities need to be further researched and this study will definitely aid in this. |