| 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
|
|
|
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
|
|
|
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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