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CTRI Number  CTRI/2025/11/097985 [Registered on: 24/11/2025] Trial Registered Prospectively
Last Modified On: 21/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Use of anaesthesia Drugs in PECS block for modified radical mastectomy.  
Scientific Title of Study   To Evaluate the efficacy of PECS block as standalone anaesthesia technique for modified radical mastectomy- A Prospective interventional 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  Dr Kanta Bhati 
Designation  Senior Professor 
Affiliation  Sardar Patel Medical College Bikaner, Rajasthan, India 
Address  Department of Anaesthesiology, Sardar Patel Medical college, Bikaner, Rajasthan.
Department of Anaesthesiology, Sardar Patel Medical college, Bikaner, Rajasthan.
Bikaner
RAJASTHAN
334001
India 
Phone  9413466688  
Fax    
Email  drkantabhati67@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kanta Bhati 
Designation  Senior Professor 
Affiliation  Sardar Patel Medical College Bikaner, Rajasthan, India 
Address  Department of Anaesthesiology, Sardar Patel Medical college, Bikaner, Rajasthan.
Department of Anaesthesiology, Sardar Patel Medical college, Bikaner, Rajasthan.
Bikaner
RAJASTHAN
334001
India 
Phone  9413466688  
Fax    
Email  drkantabhati67@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kanta Bhati 
Designation  Senior Professor 
Affiliation  Sardar Patel Medical College Bikaner, Rajasthan, India 
Address  Department of Anaesthesiology, Sardar Patel Medical college, Bikaner, Rajasthan.
Department of Anaesthesiology, Sardar Patel Medical college, Bikaner, Rajasthan.

RAJASTHAN
334001
India 
Phone  9413466688  
Fax    
Email  drkantabhati67@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Sardar Patel Medical college, Bikaner, 
 
Primary Sponsor  
Name  Department of Anaesthesiology 
Address  Department of Anaesthesiology, Sardar Patel Medical college, Bikaner, Rajasthan. 
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 Kanta Bhati  OT A block ,Department Of Anaesthesia  Department of Anaesthesia Sardar Patel Medical College Bikaner, Rajasthan, India
Bikaner
RAJASTHAN 		 9413466688

drkantabhati67@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTE,S.P.MEDICAL COLLEGE,BIKANER.  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  Nil  Nil 
Intervention  PECS I AND PECS II Block using 0.5% Ropivacaine with dexamethasone with dexmedetomidine infusion for sedation.  Ultrasound-guided PECS I and II blocks will be performed using 30 mL of 0.5 percent Ropivacaine with 4 mg Dexamethasone. Sedation will be maintained with Dexmedetomidine 1 µg/kg bolus over 10 min, followed by 0.5–0.7 µg/kg/h infusion. To ensure medial coverage, 5–10 mL of 0.25 percent Bupivacaine will be infiltrated in the parasternal region. Rescue fentanyl or GA conversion will be documented if required. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  Patients classified as American Society of Anaesthesiologists (ASA) physical status I, II OR III. 
 
ExclusionCriteria 
Details  1. Patient refusal to participate or undergo regional anesthesia.
2.Known allergy or hypersensitivity to local anesthetics or study drugs (Ropivacaine, dexamethasone, fentanyl, dexmedetomidine,bupivacaine).
3.Infection at the block site or local skin pathology.
4. Coagulopathy or bleeding disorders
5.History of severe cardiovascular or respiratory instability contraindicating sedation or regional anesthesia.
6. Neurological disorders affecting pain perception or sensory mapping.
7. Patients on chronic opioid or sedative use, which may influence block efficacy.
8.Inability to understand or communicate pain scores reliably (e.g., severe cognitive impairment).
9.BMI more than 35 kg per m², as excessive adiposity may interfere with block performance or ultrasound visualization 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
TO assess the success rate of surgeries completed without conversion to general anaesthesia.
2.Assessing the requirement of intraoperative opiod - fentanyl. 		 Before block, just after block ,then every 5 min. till 30 mins and then 1 hrly till the end of surgery  
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the intraoperative hemodynamic stability and document any complications or adverse events related to PECS block or sedation.
2.To determine the duration of postoperative analgesia. 		 To observe postoperative pain scores using NRS at 1,2,4,8,12 and 24 hours  
 
Target Sample Size   Total Sample Size="47"
Sample Size from India="47" 
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)   05/12/2025 
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="0"
Months="6"
Days="0" 
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 malignancy among women and Modified Radical Mastectomy is a frequently performed surgery. General anaesthesia, though standard, carries risks such as airway manipulation, postoperative nausea, vomiting, and hemodynamic instability, especially in high-risk patients. Pectoral nerve blocks (PECS I and II) provide a simple, ultrasound-guided regional technique that blocks pectoral, intercostobrachial, intercostal, long thoracic, and thoracodorsal nerves, reducing opioid use and recovery time. This prospective single-arm interventional study aims to evaluate the efficacy of PECS I and II blocks using 0.5 percent Ropivacaine with Dexamethasone under Dexmedetomidine sedation as the sole anaesthetic technique for Modified Radical Mastectomy. The primary outcome is successful completion of surgery without conversion to general anaesthesia. Secondary outcomes include intraoperative hemodynamic stability, intraoperative opioid requirement, and duration and quality of postoperative analgesia. 
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