| CTRI Number |
CTRI/2026/01/102226 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing ultrasound guided erector spinae plane block and serratus anterior plane block in patient undergoing breast tumor surgery and monitor time of first after surgery pain relief medication required and also look for pain level after sugery . |
|
Scientific Title of Study
|
Comparison of ultrasound guided erector spinae plane block vs. serratus anterior plane block for postoperative analgesia in case of modified radical mastectomy operation- a randomized, 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 |
Sk Javed Iqbal |
| Designation |
Junior Resident in department of Anesthesiology |
| Affiliation |
IPGMER and SSKM Kolkata |
| Address |
Mirjabazar,Medinipur, paschim medinipur,midnapore , West Bengal
Medinipur
WEST BENGAL
721101
India |
| Phone |
7908045683 |
| Fax |
|
| Email |
drjavediqbal28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arpita Laha |
| Designation |
Head of the department and Professor, Department of Anesthesiology |
| Affiliation |
IPGMER and SSKM , KOLKATA |
| Address |
10, east road , Jadavpur, Kolkata
Kolkata
WEST BENGAL
700032
India |
| Phone |
9433326667 |
| Fax |
|
| Email |
arpita_laha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Arpita Laha |
| Designation |
Head of the department and Professor, Department of Anesthesiology |
| Affiliation |
IPGMER and SSKM , KOLKATA |
| Address |
10, east road , Jadavpur, Kolkata
Kolkata
WEST BENGAL
700032
India |
| Phone |
9433326667 |
| Fax |
|
| Email |
arpita_laha@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, IPGMER, KOLKATA , West bengal , 700071, India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology IPGMER KOLKATA |
| Address |
IPGMER,244,AJC Bose road , Kolkata , west bengal , 700071, India |
| 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 Sk javed iqbal |
Institute of post graduate medical education and research and SSKM |
Department of Anesthesiology in the General Surgery Operating room,244,AJC Bose Road, Kolkata -700071, Kolkata, West Bengal
Kolkata
WEST BENGAL |
7908045683
drjavediqbal28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided Erector Spinae plane block VS Serratus Anterior plane block for post operative analgesia in case of Modified Radical Mastectomy operation |
To compare post operative pain (using VAS) and time of first rescue analgesia (in min) postoperatively between group received ultrasound guided erector spinae plane block versus Serratus Anterior plane block. The secondary outcome will be comparison of intraoperative Fentanyl requirement half hourly after watching HR,MAP,SBP and DBP , perioprative vital signs like MAP,HR ,then postoperative total analgesia consumption (Tramadol in mg)and overall analgesia satisfaction will be assessed . Also any adverse events occurring during the procedure and time taken will be recorded. |
| Comparator Agent |
Ultrasound guided Erector Spinae plane block VS Serratus Anterior plane block for post operative analgesia in case of Modified Radical Mastectomy operation. |
To compare post operative pain (using VAS) and time of first rescue analgesia (in min) postoperatively between group received ultrasound guided erector spinae plane block versus Serratus Anterior plane block. The secondary outcome will be comparison of intraoperative Fentanyl requirement half hourly after watching HR,MAP,SBP and DBP , perioprative vital signs like MAP,HR ,then postoperative total analgesia consumption (Tramadol in mg)and overall analgesia satisfaction will be assessed . Also any adverse events occurring during the procedure and time taken will be recorded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1) Patients that have given written, informed consent to participate in the study.
2)American society of anaesthesiologist (ASA) physical status I-II.
3) Age 18-65 years old.
4)Body mass index below 30 kg/m2.
5) Patients undergoing elective modified radical Mastectomy . |
|
| ExclusionCriteria |
| Details |
1) Age 65 years old.
2)The chronic use of analgesics or anti inflammatory drugs
3) Allergy to local anesthetics or any of the study drugs.
4 )History of co-morbidities ( MI, asthma, COPD , T2DM,Heart Failure etc.)
5)Pregnancy or lactation
6)Patients with thrombocytopenia,coagulopathies, infection at site of block.
7)Inability to communicate due to dementia, language barrier or end stage disease.
8)Refusal to participate in study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare post operative pain(using VAS)and time of first rescue analgesia(in min)postoperatively between group received ultrasound guided erector spinae plane block versus Serratus Anterior Plane block vs control group. |
time of first rescue analgesia(in min)postoperatively between group received ultrasound guided erector spinae plane block versus Serratus Anterior Plane block vs control group. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To determine the total postoperative analgesia consumption (Tramadol in mg) .
• To determine intraoperative fentanyl consumption (by seeing MAP and Heart Rate)half hourly.
• To determine intra and post operative hemodynamics .(HR, SBP, DBP, MAP – 30 mins interval)
• To determine post operative patient satisfaction using satisfaction score[3](4=excellent,3=good,2=fair and 1=poor) .
• To determine the incidence of adverse events( post operative nausea vomitting,delayed post operative recovery , pain at the site injection site , local hematoma formation, adverse effects to local anesthetics , pneumothorax) . |
(HR, SBP, DBP, MAP – 30 mins interval) |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
10/02/2026 |
| 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="1"
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 study will compare the post operative pain using VAS score and time of first rescue analgesia in min postoperatively in case of modified radical mastectomy patients. Patients will be divided into two groups A and B , each group will be given Usg guided Erector spinae plane block and Usg guided Serratus Anterior plane block respectively. The secondary outcome will be comparison of intraoperative fentanyl requirement half hourly after watching HR,MAP,SBP and DBP, peri operative vitals like MAP , HR , then postoperative total analgesia consumption (Tramadol in mg) and overall analgesia satisfaction will be assessed. Also any adverse events occurring during the procedure and time taken will be assessed. |