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CTRI Number  CTRI/2025/11/097090 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On: 04/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Other (Specify) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Ultrasound guided Erector spinae plane block versus Retrolaminar block for post operative analgesia for patients undergoing Modified Radical Mastectomy 
Scientific Title of Study   Ultrasound guided erector spinae plane block versus retrolaminar block for post operative analgesia in patients under going modified radical mastectomy- a randomised controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vijikrishna V 
Designation  Post graduate 
Affiliation  Aarupadai veedu medical college and hospital  
Address  First year post graduate Department of Anesthesiology Aarupadai Veedu Medical College Kirumampakkam

Pondicherry
PONDICHERRY
607402
India 
Phone  8547682972  
Fax    
Email  vijikrishna999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M Suresh Rajkumar  
Designation  Professor  
Affiliation   
Address  Department of Anaesthesiology First Floor A Block Aarupadai Veedu medical college and hospital Kirumampakkam Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9894723687  
Fax    
Email  bommidisrk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pradeesh Johny 
Designation  Assistant Professor 
Affiliation   
Address  Department of anesthesiology First Floor A block Aarupadai Veedu medical college and hospital Kirumampakkam Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9003549061  
Fax    
Email  pradeeshjohny@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiolgy First floor A block Aarupadai Veedu medical college and hospital Kirumampakkam Pondicherry PONDICHERRY 607402 India 
 
Primary Sponsor  
Name  Aarupadai veedu medical college and hospital 
Address  Aarupadai veedu medical college Kirumampakkam Pondicherry cuddalore highway Pondicherry India Pin code 607402 
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 
Dr Vijikrishna V   Aarupadai veedu medical college and Hopsital  Department of Anaesthesiology First floor A Block Kirumampakkam Cuddalore POndicherry Highway Pondicherry
Pondicherry
PONDICHERRY 
8547682972

vijikrishna999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional human ethics committe aarupadai veedu medical college  Approved 
Institutional human ethics committe aarupadai veedu medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.25 % Levobupivacaine  0.5 % Levobupivacaine 10 ML diluted to 20 M L OF 0.25 % Levobupivacaine 
Intervention  Erector Spinae Plane block  Nerve block needle will be inserted under USG guidance to contact tip of the T4 transverse process for Erector Spinae Plane block and a total of 25 ml 0.25 % levobupivacaine will be injected at T4 transverse process. 
Intervention  Retrolaminar BLock  Nerve block needle will be inserted under USG guidance to contact tip of the T4 laminae of the vertebare for Retrolaminar block and a total of 25 ml 0.25 % levobupivacaine will be injected at T4 laminae Duration of procedure 10-15 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Posted for unilateral Modified Radical Mastectomy under General anesthesia  
 
ExclusionCriteria 
Details  ASA Class IV
History of daily consumption of opiods and analgesics
Previous surgery in thoracic vertrbral region
BMI more than 30
Any infection at block site
Previous allergy to drug used for the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare post operative analgesic efficacy of Erector Spinae Plane block and Retrolaminar Block in terms of the time taken to receive first rescue analgesic in patients undergoing Unilateral Modified Radical Mastectomy  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the intensity of pain during the first 24 hours using VAS score
To assess the total rescue analgesics consumption over 24 hours
To assess the occurrence of complications like Post operative nausea and vomiting (PONV), Hematoma
 
24 HOURS 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   20/11/2025 
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)  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 in India accounting for 32% of all women cancers.  The incidence is 35 per 100,000 women with 75000 new cases diagnosed and 40,000 deaths per year. Most commonly the surgical approach of choice is  Modified Radical Mastectomy (MRM),  due to it allowing for both the removal of the main tumor  mass and adjacent glandular tissue, which are suspected of infiltration and multifocality of the  process, and a sentinel axillary lymph node removal.(1)  Acute pain after breast surgery may lead to the development of chronic persistent pain in women undergoing such procedures.  Blocking the nociceptive inputs through the intercostal nerves is important for the postoperative pain control after breast surgery, because cutaneous innervation of the breast is mainly derived from the intercostal nerves, along with supraclavicular nerves.(2)  Thoracic paravertebral block (TPVB) is widely used for providing post operative analgesia after breast surgery . This technique is having risk of   development of pneumothorax.(3) Erector Spinae Block targets the transverse process and mechanism of action is by spread of local anaesthetics into the paravertebral space and intercostal space. The Retrolaminar Block target lamina of vertebra and mechanism is by spread of local anaesthetic into the paravertebral space.(4)  So Retrolaminar Block and Erector Spinae Plane block are easier and safer alternative techniques to TPVB .

 
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