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CTRI Number  CTRI/2026/01/100669 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Improving recovery and a better path to comfort After Breast Cancer surgery- A clinical study which utilizes targeted numbing injection to the chest wall given right after the surgery, and check pain level.  
Scientific Title of Study   The Efficacy of Post-Procedure PECS Block for Pain Management in Modified Radical Mastectomy. A Prospective Randomized, Double Blinded 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  Sudi CutyMahlah 
Designation  PG Registrar 
Affiliation  Christian Medical College, Vellore. 
Address  Department of Anaesthesiology,Christian Medical College, Vellore.

Vellore
TAMIL NADU
632002
India 
Phone  8143218138  
Fax    
Email  cutymahlah@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  S Chitra 
Designation  Professor 
Affiliation  Christian Medical College, Vellore. 
Address  Department of Anaesthesiology,Christian Medical College, Vellore.

Vellore
TAMIL NADU
632002
India 
Phone  9965565990  
Fax    
Email  chitraanaes73@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sudi CutyMahlah 
Designation  PG Registrar 
Affiliation  Christian Medical College, Vellore. 
Address  Department of Anaesthesiology,Christian Medical College, Vellore.

Vellore
TAMIL NADU
632002
India 
Phone  8143218138  
Fax    
Email  cutymahlah@gmail.com  
 
Source of Monetary or Material Support  
Fluid Research Grant, Christian Medical College, Vellore, 632002, Tamil Nadu, India. 
 
Primary Sponsor  
Name  Institutional Fluid Research Grant 
Address  Christian Medical College Vellore, 632002, Tamil Nadu, India. 
Type of Sponsor  Private 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 
DrSudi CutyMahlah  Christian Medical College, Vellore  OT COMPLEX, General Surgery, Endocrine Surgery, Department of Anaesthesiology. thotapalayam,Vellore, 632002
Vellore
TAMIL NADU 
8143218138

cutymahlah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Silver Ethics and Research Committee Christian medical College Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  control  The other group will not receive any block 
Intervention  PECS II Block  Intervention: The block will involve: Pectoral Nerves: Injecting 10 mL of 0.375% Ropivacaine between the pectoralis major and minor muscles. Serratus Plane: Injecting 20 mL of 0.375% Ropivacaine deep to the serratus anterior muscle (between the serratus anterior and the intercostal muscles). Total Volume/Dose: 30 mL of 0.375% Ropivacaine. Group A will receive PECS block intraoperatively by the operating surgeon  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  patients posted for Modified Radical Mastectomy. 
 
ExclusionCriteria 
Details  1.Patient refusal 2. Patient’s history of allergic reaction to local anesthetics 3. Psychiatric or cognitive impairment preventing accurate pain assessment.4. Pre-existing chronic pain or daily opioid use. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
assessment of Pain scores at Rest and Movement.  at rest (0,4,8,12,24) hours
Movement (8,12,24 hours) 
 
Secondary Outcome  
Outcome  TimePoints 
1.Time for first rescue analgesia.
2.Total consumption of Rescue Analgesia
 
in first 24 hours 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   20/01/2026 
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="0"
Months="6"
Days="15" 
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  

      Breast cancer is the most common cancer among women, with surgery being a primary treatment option. A modified radical mastectomy is a standard procedure. Postoperative pain can significantly impact quality of life and may lead to chronic pain syndrome. Various nerve blocks, such as thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks, have been utilised for anaesthesia and pain relief during modified radical mastectomy. However, their use is often limited due to the complexity of the procedures and the risk of severe complications.

Recently, there has been growing interest in a new, less invasive approach known as the pectoral nerve (PECS) block. The PECS block is an increasingly used regional anaesthetic technique for postoperative pain management in patients undergoing breast surgeries, including modified radical mastectomy. It offers a promising alternative to traditional methods, aiming to reduce post-op pain and improve patient satisfaction.

The PECS I block is performed between the pectoralis major and minor muscles, while the PECS II block adds an injection above the serratus anterior muscle at the third rib. Studies indicate that administering the PECS block before general anaesthesia can spread local anaesthetics along fascial planes and limit electrocautery use, leading to surgical clarity issues. To mitigate these problems, some surgeons now perform pectoral nerve blocks under direct vision just before closure to enhance postoperative analgesia in breast surgeries.


 
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