| CTRI Number |
CTRI/2025/06/089815 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
28/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Medical Device Surgical/Anesthesia Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing post-mastectomy pain relief |
|
Scientific Title of Study
|
Assessing post-mastectomy pain relief: a randomised comparative study of USG erector spinae block and MTP block |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashu |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Department of Anaesthesiology
King Georges Medical University
Gandhi Memorial and Associated Hospital
Shahmina Road
Chowk
Lucknow Lucknow UTTAR PRADESH 226003 India |
| Phone |
8400253275 |
| Fax |
|
| Email |
dwivediashu95@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prem Raj Singh |
| Designation |
Additional Professor |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Additional Professor
Department of Anaesthesiology
King Georges Medical University
Gandhi Memorial and Associated Hospital
Shahmina Road
Chowk
Lucknow Lucknow UTTAR PRADESH 226003 India |
| Phone |
9918478136 |
| Fax |
|
| Email |
dr.p.rajsingh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prem Raj Singh |
| Designation |
Additional Professor |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Additional Professor
Department of Anaesthesiology
King Georges Medical University
Gandhi Memorial and Associated Hospital
Shahmina Road
Chowk
Lucknow
UTTAR PRADESH 226003 India |
| Phone |
9918478136 |
| Fax |
|
| Email |
dr.p.rajsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
King George Medical University
Gandhi Memorial and Associated Hospital
Shahmina Road
Chowk
Lucknow |
|
|
Primary Sponsor
|
| Name |
Operation Theater |
| Address |
Department of Anaesthesiology
King Georges Medical University
Gandhi Memorial and Associated Hospital
Shahmina Road
Chowk
Lucknow
|
| 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 Prem Raj Singh |
Operation theater |
Department of Anaesthesiology
King Georges Medical University
Gandhi Memorial and Associated Hospital
Shahmina Road
Chowk
Lucknow
Lucknow UTTAR PRADESH |
9918478136
dr.p.rajsingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
post-mastectomy pain relief, reduce opioid consumption, and enhance recovery outcomes. |
post-mastectomy pain relief, reduce opioid consumption, and enhance recovery outcomes. |
| Intervention |
two different pain management techniques post-mastectomy: the Ultrasound-Guided Erector Spinae Block (ESB) and the Modified Thoracic Paravertebral Block (MTP). The study will compare their effectiveness in providing post-operative analgesia, assessing pain relief, opioid consumption, and patient recovery outcomes |
two different pain management techniques post-mastectomy: the Ultrasound-Guided Erector Spinae Block (ESB) and the Modified Thoracic Paravertebral Block (MTP). The study will compare their effectiveness in providing post-operative analgesia, assessing pain relief, opioid consumption, and patient recovery outcomes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
36.00 Year(s) |
| Gender |
Female |
| Details |
Schedule For Major Breast Surgery
ASA Physical Status 1 To 2
BMI Less Than 30 |
|
| ExclusionCriteria |
| Details |
Prior Breast Surgeries
Patients Refusal
Contraindications To Regional Anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the VAS score between the two groups |
To compare the VAS score between the two groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Opioid consumption
Time for first rescue analgesia
Hemodynamic changes
Any complications ex- post operative nausea, vomiting
|
Opioid consumption
Time for first rescue analgesia
Hemodynamic changes
Any complications ex- post operative nausea, vomiting
|
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
10/07/2025 |
| 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
|
Breast cancer is a prevalent cancer among
females worldwide, and surgical procedures can cause significant postoperative
pain. Effective pain management protocols, such as regional anesthesia and less
invasive surgical techniques, can reduce hospital stays. Ultrasound-guided
fascial plane blocks have shown efficacy in managing pain following mastectomy,
but there is no consensus on the ideal volume concentration, distribution, and
dermatomal coverage. Most research on ESPB mechanism of action has been
conducted on cadaversic subjects yielding inconsistent results due to not all
experiencing substantial dye dissemination. Methylene blue, the most commonly
used dye for corpses, has faced criticism for excessive spreading and
insufficient dissection technique. Assessing post mastectomy pain relief is
crucial due to the significant physical and psychological burden experienced by
patients. This randomized comparative study focuses on ultrasound-guided
erector spinae block and mid transverse pleura block, aiming to provide insights
into their benefits and limitations, aiding clinicians in selecting the most
appropriate approach based on individual patient characteristics and surgical
considerations.
The significance of this study lies in evaluating and comparing two
effective pain management techniques, Ultrasound-Guided Erector Spinae Block
and the Modified Thoracic Paravertebral Block for post-mastectomy
patients. Post-operative pain management is crucial for improving recovery,
reducing opioid consumption, and enhancing patient satisfaction. By determining
which technique offers superior pain relief and fewer complications, this study
could influence clinical practice and provide evidence for selecting the most
effective and safe method of pain control post-mastectomy. The findings may
contribute to optimizing pain management strategies improving patient outcomes,
and reducing healthcare costs related to post-operative care.
The research hypothesis for this randomized comparative study is
that the Ultrasound-Guided Erector Spinae Block will provide superior post-mastectomy pain
relief compared to the Modified Thoracic Paravertebral Block.
Specifically, it is hypothesized that the ESB will result in lower pain scores,
reduced opioid consumption, and improved overall recovery in the post operative
period. Additionally the study aims to assess any differences in complication
rates and patient satisfaction between the two pain management techniques.
The study aims to compare the analgesic efficacy of mid transverse
pleura block and erector spinae block after modified radical mastectomy surgery
using VAS score during the first 24hour post operative period. The objectives
include comparing VAS score examining opioid consumption, time for first rescue
analgesia, hemodynamic changes, and any complications post-operatively.
The study
will be conducted at Department of Anaesthesiology King George Medical
University Lucknow after obtaining ethical approval from the research cell The
study will last for one and a half years and will use a randomised controlled
trial design. The study will include two
groups
Group I which
will receive 20 Ml 0.25percent Bupivacaine With 10 Mg Dexamathasone
Group II
which will receive 20 Ml 0.25 percent Bupivacaine With 10 Mg Dexamathasone.
Both groups
will receive injections of 15ml kg 8 hourly.
Statistical
analysis will be conducted using SPSS and MS Excel, with continuous variables
expressed as mean standard deviation counting data as number and percentages,
and unpaired t tests or non-parametric equivalents for inter-group analysis.
The chi square test will be used to compare proportion data between the groups.
P value less than zero will be considered statistically significant in all
statistical analyses. The study aims to provide a comprehensive understanding
of the benefits of bupivacaine and dexamathasone in breast surgery.
|