| CTRI Number |
CTRI/2026/02/104305 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study of Two Nerve Block (Intertransverse and Thoracic Paravertebral)for Pain Relief after Modified Radical Mastectomy Surgery |
|
Scientific Title of Study
|
Comparing intertransverse process (ITP) block with thoracic paravertebral (TPV) block for postoperative analgesia in patient undergoing modified radical mastectomy (MRM); A randomized controlled non inferiority 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 |
Dr Piyush Meena |
| Designation |
Junior resident |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7426880528 |
| Fax |
|
| Email |
piyushmeena1642@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ghanshyam Yadav |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9838894169 |
| Fax |
|
| Email |
ghanshyambhu1976@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Ghanshyam Yadav |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9838894169 |
| Fax |
|
| Email |
ghanshyambhu1976@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India 221005 |
|
|
Primary Sponsor
|
| Name |
Dr Piyush Meena |
| Address |
Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India 221005 |
| Type of Sponsor |
Other [Self] |
|
|
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 Piyush Meena |
Sir Sunderlal Hospital BHU |
Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India 221005
Varanasi
UTTAR PRADESH |
7426880528
piyushmeena1642@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee BHU Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inter transverse Process(ITP) Block |
Inter transverse Process(ITP) block given using 20ml 0.2% ropivacaine + 4ml dexamethasone at T4-T5 level at midpoint between the transverse process and pleura |
| Comparator Agent |
Thoracic Paravertebral(TPV) Block |
Thoracic paravertebral(TPV) block given using 20ml 0.2% ropivacaine + 4ml dexamethasone at T4-T5 level in thoracic paravertebral space |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.ASA 1 and ASA 2 patients
2.Patient undergoing MRM under General Anaesthesia
3.Patient between 18 to 65 years of age
4.Patient who can understand and provide a valid consent for the procedure and can understand and are willing to report the pain using NRS score |
|
| ExclusionCriteria |
| Details |
1.Patients not giving consent
2.Patient with allergies to Local anaesthetics
3.Patient having bleeding disorders
4.Patient on anticoagulant or antiplatelet drus
5.Localised infections
6.Patient in whom the sonoanatomy of the anaesthetiic injection site is clearly not delineable due to any reason
7.Patient with previous history of breast surgery
8.Patient on long term opioid therapy
9.Patient with peripheral neuropathy
10.INR more than 1.5 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of the pain using NRS score at 24 hours postoperatively among both group |
24th hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To observe the time needed for first rescue analgesia(IV Tramadol)
2.To compare the total number of dose of rescue analgesia required to achieve adequate analgesia
3.To compare intraoperative hemodynamic parameters(Heart rate,Mean arterial pressure,Systolic blood pressure,Diastolic blood pressure)
4.To compare intraoperative intravenous fentanyl consumption
5.To compare time taken to perform the block |
intraoperative assessment at baseline parameters and 15,30,45,60,75,90,105,120 minutes intraoperatively and postoperative assessment at 30minute,1,2,6,12,24,48 hrs |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/03/2026 |
| 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="4"
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 is a double blinded prospective randomized controlled trial comparing the effectiveness of pre operative administration after induction of intertransverse process(ITP) block with thoracic paravertebral(TPV) block on post operative pain relief after modified radical mastectomy(MRM) and will bw carried out in the Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi.The primary outcome will measure the extent of pain. The intensity of pain variable will be recorded using Numerical rating scale(NRS), ranging from 0(no pain) to 10(maximum pain). Each patient will be asked to rate the perceived pain at 30minutes,1,2,6,12,24 and 48 hours post operatively. The secondary outcomes will observe the time needed for first dose of rescue analgesia( IV Tramadol) and total number of dose of rescue analgesia (Tramadol 2mg/kg IV)required for adequate analgesia, intra operative hemodynamic parameters, intra operative fentanyl consumption and time taken to perform the block. |