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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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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.

 

 

 
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