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CTRI Number  CTRI/2025/10/096234 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On: 18/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare the effects of Dexmedetomidine and Clonidine with Ropivacaine on relief of pain after surgery for breast cancer. 
Scientific Title of Study   A comparative study between Dexmedetomidine and Clonidine as adjuvant with Ropivacaine in ultrasound guided erector spinae block for post operative analgesia in modified radical mastectomy. 
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 Koushikee Chandra 
Designation  Post graduate trainee 
Affiliation  Burdwan Medical College and Hospital 
Address  Department of Anaesthesiology Office of the Principal Burdwan Medical College and Hospital Baburbag, Burdwan

Barddhaman
WEST BENGAL
713104
India 
Phone  9123372169  
Fax    
Email  koushikeechandra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tirthasish Mandal 
Designation  Assistant Professor 
Affiliation  Burdwan Medical College and Hospital 
Address  A F/2 Aalingan apartment Sanchita Park Bidhannagar P.O. - ABL Durgapur

Barddhaman
WEST BENGAL
713206
India 
Phone  8768726509  
Fax    
Email  tirthasishm@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tirthasish Mandal 
Designation  Assistant Professor 
Affiliation  Burdwan Medical College and Hospital 
Address  A F/2 Aalingan apartment Sanchita Park Bidhannagar P.O. - ABL Durgapur

Barddhaman
WEST BENGAL
713206
India 
Phone  8768726509  
Fax    
Email  tirthasishm@rediffmail.com  
 
Source of Monetary or Material Support  
The Principal Burdwan Medical College and Hospital P.O.-Baburbagh, District - Paschim Bardhaman PIN-713104,West Bengal, India  
 
Primary Sponsor  
Name  Dr Koushikee Chandra 
Address  Department of Anaesthesiology Office of the Principal Burdwan Medical College and Hospital Baburbag Burdwan - 713104 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Koushikee Chandra  Burdwan Medical College and Hospital   Department of Anaesthesiology Office of the Principal P.O.- Baburbag District - Purba Bardhaman PIN-713104
Barddhaman
WEST BENGAL 
9123372169

koushikeechandra@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Burdwan Medical College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 3||Administration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clonidine with Ropivacaine  Clonidine 1 mcg per kg mixed with Ropivacaine 0.5% 20 ml to be injected into erector spinae plane under ultrasound guidance Frequency:only once Route of administration: intramuscular Duration:24 hrs 
Intervention  Dexmedetomidine with Ropivacaine  Dexmedetomidine 1 mcg per kg mixed with Ropivacaine 0.5% 20 ml to be injected into erector spinae plane under ultrasound guidance Frequency:only once Route of administration: intramuscular Duration: 24 hrs  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status I II or III
BMI less than 30 kg per square meter
Modified radical mastectomy surgery 
 
ExclusionCriteria 
Details  ASA physical status IV
Patient refusal
Patients with untreated COPD DM Bronchial asthma obstructive sleep apnoea uncontrolled hypertension
Patients with known hypersensitivity to study drugs
Patients with coagulation disorder 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual analog scale for pain score  at 0 hrs (base line) 3,6,9,12,15,18,21 and 24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Ramsay sedation scale score
Mean arterial pressure
Heart rate 
at 0 hrs (base line) 3,6,9,12,15,18,21 and 24 hrs for all three parameters 
 
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   N/A 
Date of First Enrollment (India)   03/11/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Summary:
Breast cancer surgeries are increasingly performed but adequate postoperative analgesia is often 
not achieved leading to complications and worsened quality of life. Erector Spinae Plane Block
 using ropivacaine has emerged as a promising regional anaesthesia technique that can 
effectively control pain and offers lesser complications than their alternate available modalities. 
Alpha2 adrenergic agonists like clonidine and dexmedetomidine are used as adjuvants in peripheral 
nerve blocks to increase the duration of analgesia for effective control of pain. Very few studies 
have been done to compare their efficacy in ESPB. Hence this study is proposed to explore their 
differences.
OBJECTIVE OF PROPOSED RESEARCH
To compare the duration of analgesia between dexmedetomidine and clonidine as an adjuvant in 
ultrasound guided Erector Spinae Plane Block using Ropivacaine.
METHODOLOGY
After getting approval of the Institutional Ethics Committee, patient recruitment will be done. 
Selection of patients base on the inclusion and exclusion criteria will be followed by proper 
counselling and informed consent will be taken. Patients will be divided by sequential sampling in
either of two groups, RC and RD; according to the adjuvant clonidine or dexmedetomidine use.
Preoperative US-guided ESPB will be done and in the postoperative period the duration of 
analgesia, level of sedation and hemodynamic parameters will be measured.
EXPECTED OUTCOME
At the end of this study, we will find out if there is any significant difference between 
dexmedetomidine and clonidine in their ability to increase the duration of analgesia when used as an 
adjunct to ropivacaine in erector spinae plane block.

 
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