| 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
|
|
|
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
|
|
|
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 . |