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CTRI Number  CTRI/2025/10/096488 [Registered on: 27/10/2025] Trial Registered Prospectively
Last Modified On: 24/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Which nerve block works best for pain relief for mastecomy patients -MTP or Paravertebral? 
Scientific Title of Study   Mid point transverse process to pleura block versus thoracic paravertebral block for post operative analgesia in patients undergoing Modified radical mastectomy-a randomized controlled non inferiority study (Academic 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  Damu Harish Kumar 
Designation  Doctor,Junior resident 
Affiliation  AIIMS MANGALAGIRI 
Address  Department of Anaesthesiology,AIIMS MANGALAGIRI,Guntur,Andhra pradesh 522503

Guntur
ANDHRA PRADESH
522503
India 
Phone  7995986635  
Fax    
Email  harishbunny71@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vamsidhar Chamala 
Designation  Associate professor 
Affiliation  AIIMS MANGALAGIRI 
Address  Department of Anaesthesiology,AIIMS MANGALAGIRI,Guntur,Andhra pradesh 522503

Guntur
ANDHRA PRADESH
522503
India 
Phone  8867305588  
Fax    
Email  drvamshi.anesth@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Public Query  
Name  Damu Harish Kumar 
Designation  Doctor,Junior resident 
Affiliation  AIIMS MANGALAGIRI 
Address  Department of Anaesthesiology,AIIMS MANGALAGIRI,Guntur,Andhra pradesh 522503

Guntur
ANDHRA PRADESH
522503
India 
Phone  7995986635  
Fax    
Email  harishbunny71@gmail.com  
 
Source of Monetary or Material Support  
AIIMS MANGALAGIRI GUNTUR ANDHRA PRADESH 522503 
 
Primary Sponsor  
Name  Damu Harish kumar 
Address  Junior Resident(Academic),Department of Anesthesiology,All India Institute of Medical Sciences(AIIMS),Mangalagiri,Guntur district,Andhra pradesh-522503,India 
Type of Sponsor  Other [none] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  Junior Resident(Academic),Department of Anesthesiology,All India Institute of Medical Sciences(AIIMS),Mangalagiri,Guntur district,Andhra pradesh-522503,India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Damu Harish Kumar  AIIMS MANGALAGIRI  Room no 1053,Department of Anesthesiology,MANGALAGIRI,Guntur District,Andhra pradesh-522503
Guntur
ANDHRA PRADESH 		 7995986635

harishbunny71@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee Aiims Mangalagiri  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Mid point transverse process to pleura block and thoracic para vertebral block in patients undergoing modified radical mastectomy  Comparision of mid point transverse process to pleura block and thoracic para vertebral block using 20ml of injection 0.2% ropivacaine with 4 mg of dexamethasone given once for duration of about 5 minutes at T4-T5 level in patients undergoing modified radical mastectomy 
Intervention  Mid point transverse process to pleura block and thoracic para vertebral block in patients undergoing modified radical mastectomy  Mid point transverse process to pleura block and thoracic para vertebral block using 20ml of injection 0.2% ropivacaine with 4 mg of dexamethasone given once for duration of about 5 minutes at T4-T5 level in patients undergoing modified radical mastectomy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients undergoing modified radical mastectomy  
 
ExclusionCriteria 
Details  Patient refusal, Patient’s age less than 18years of age and greater than 65 years of age, ASA PS 3 and above, Patients with known allergy to local anaesthetics, Infection at the site of needle puncture, Bleeding diathesis, Presence of tumour in the paravertebral region and thoracic spine deformity 
 
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 
To compare post operative pain scores  Patients will be assessed immediately after shifting to post operative room followed by 4th hourly till 12 hours and 12th hourly till 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To measure post operative consumption of other analgesics, to assess the complications involved in both techniques, to measure the duration of both blocks, to assess hemodynamic changes post operatively  Patients will be assessed immediately after shifting to post operative room followed by 4th hourly till 12 hours and 12th hourly till 48 hours 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   04/11/2025 
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   Most patients undergoing breast surgery complain of acute postoperative pain in the chest, arm, and axilla. If untreated, this leads to chronic pain and restriction of shoulder movements, thus decreasing the quality of life of breast cancer survivors. Preventive analgesia through multimodal approaches ensures control of continuous neuronal firing, which eventually decreases the incidence of chronic pain, morbidity, and mortality. Among the various regional anesthesia techniques used for postoperative analgesia in the) modified radical mastectomy (MRM), thoracic paravertebral block (TPVB) is presently considered the technique of choice. Recently, a newer technique, “midpoint transverse process to pleura” (MTP) block has been described in which the tip of the needle is placed at the midpoint between the transverse process and pleura. MTP block is a novel technique that has been hypothesized to be a safe alternative that achieves paravertebral block with an injection between the midpoint of the posterior transverse process and pleura. 
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