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CTRI Number  CTRI/2026/02/103892 [Registered on: 16/02/2026] Trial Registered Prospectively
Last Modified On: 13/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An observational study to compare two pain relief methods after breast surgery—an intravenous drug and a regional nerve block injection ,to see which one has a longer pain relief effect post surgery  
Scientific Title of Study   Comparison of Erector Spinae Plane block and Intravenous Dexmedetomidine for postoperative pain relief in patients undergoing breast surgery 
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 Simran Shetty  
Designation  Post graduate student 
Affiliation  Kasturba Medical College , Mangalore  
Address  Department of Anesthesiology, Kasturba Medical College, Light House Hill Road, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9964741496  
Fax    
Email  simranshetty140199@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ranjan Ramakrishna K 
Designation  Professor 
Affiliation  Kasturba Medical College , Mangalore 
Address  Department of Anesthesiology Kasturba Medical College, Light House Hill Road, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9449837154  
Fax    
Email  drranjanrao@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Simran Shetty  
Designation  Post graduate student 
Affiliation  Kasturba Medical College , Mangalore 
Address  Department of Anesthesiology Kasturba Medical College, Light House Hill Road, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9964741496  
Fax    
Email  simranshetty140199@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Simran Shetty 
Address  Department of Anaesthesiology Kasturba Medical College Light House Hill Road Mangalore 575 001  
Type of Sponsor  Other [Self] 
 
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 Chakrapani M Medical Superintendent  Kasturba Medical College Hospital Attavar  Kasturba Medical College Hospital, Nandigudda Road , Attavar , Mangaluru , Karnataka 575001
Dakshina Kannada
KARNATAKA 
08242422271

ms.kmchat@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Kasturba Medical College Mangalore  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 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  INCLUSION CRITERIA:
1)Female patients aged between 18-75 years
2)Elective mastectomy surgery under general anaesthesia.
3)American society of anaesthesiologists class I - II patients.
 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA:
1)Patient refusal.
2)Pregnant patients.
3)Patients with psychiatric diagnosis/cognitive dysfunction
4)Surgical duration more than 6 hrs
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome
1)Duration of post operative analgesia
2)Post operative Visual Analogue scale ( VAS score )
 
1. The data for duration of post operative analgesia and post operative visual analogue scale for each sample will be collected by then end of 24 hrs.

2. Correlation of data will be done after complete data collection - 1 year from the time of ethics committee approval 
 
Secondary Outcome  
Outcome  TimePoints 
1. Requirement of rescue analgesia
2. RSS ( Ramsay Sedation Scale) sedation score
3. Hemodynamic parameters – Heart Rate , Systolic Blood Pressure , Diastolic Blood pressure , Respiratory Rate , Saturation

 
The secondary outcome data for each sample will be collected by the end of 24 hrs.

Correlation of data will be done after complete data collection - 1 year from the time of ethics committee approval 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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   N/A 
Date of First Enrollment (India)   15/03/2026 
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="2"
Months="0"
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  
This dissertation protocol proposes a prospective, comparative observational study to evaluate and compare the effectiveness of the Erector Spinae Plane (ESP) block versus intravenous dexmedetomidine for postoperative analgesia in patients undergoing mastectomy. Given the high incidence of moderate-to-severe acute pain and the risk of chronic post-mastectomy pain syndrome, the study addresses a clear knowledge gap, as both techniques are well studied individually but lack direct head-to-head comparison.
The study will be conducted at Kasturba Medical College hospitals and will include ASA I–II female patients aged 18–75 years undergoing elective mastectomy under general anesthesia. A total of 74 patients (37 per group) will be enrolled using convenience sampling. Patients will be allocated to either Group A (ultrasound-guided ESP block at T4 with local anesthetic) or Group B (IV dexmedetomidine loading dose followed by infusion). Standardized general anesthesia will be administered to all patients, and postoperative pain will be assessed using VAS scores at 1, 12, and 24 hours.
The primary outcome is postoperative analgesic efficacy, assessed by duration and intensity of pain relief. Secondary outcomes include the requirement for rescue analgesia and comparison of hemodynamic parameters (heart rate, blood pressure, oxygen saturation, respiratory rate), along with monitoring for adverse effects such as hypotension or bradycardia. Data will be analyzed using appropriate parametric or non-parametric tests, with statistical significance set at p < 0.05.
Overall, the study aims to determine which modality provides longer-lasting analgesia, reduced need for rescue analgesics, and better hemodynamic stability, thereby guiding optimal postoperative pain management strategies for mastectomy patients.
 
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