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CTRI Number  CTRI/2022/07/044423 [Registered on: 28/07/2022] Trial Registered Prospectively
Last Modified On: 24/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Anaesthesia to reduce pain after breast surgery 
Scientific Title of Study   Comparison of efficacy of ultrasound guided thoracic paravertebral block (TPVB) with combined pectoral nerve block (PEC) and pecto-intercostal fascial block (PICF) for perioperative analgesia in modified radical mastectomy: a randomised control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Adarsh M Sheshagiri 
Designation  PG Resident 
Affiliation  AIIMS Patna 
Address  Department of Anaesthesiology Room No 13, OPD Complex AIIMS Patna, Phulwarisharif Patna Bihar

Patna
BIHAR
801507
India 
Phone  7026748639  
Fax    
Email  msadarsh256@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ajeet Kumar 
Designation  Additional Professor 
Affiliation  AIIMS Patna 
Address  Department of Anaesthesiology Room No 13, OPD Complex AIIMS Patna, Phulwarisharif Patna Bihar

Patna
BIHAR
801507
India 
Phone  9312501413  
Fax    
Email  ajeetanaes@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ajeet Kumar 
Designation  Additional Professor 
Affiliation  AIIMS Patna 
Address  Department of Anaesthesiology Room No 13, OPD Complex AIIMS Patna, Phulwarisharif Patna Bihar

Rohtas
BIHAR
801507
India 
Phone  9312501413  
Fax    
Email  ajeetanaes@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology, All india institute of medical sciences, Phulwarisharif, Patna 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology B Block OT Complex AIIMS Patna, Phulwarisharif Patna Bihar  
Type of Sponsor  Government 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 
Adarsh M Sheshagiri  All India Institute of Medical Sciences, Patna  Department of Anaesthesiology B Block OT complex AIIMS Patna, Phulwarisharif Patna Bihar
Patna
BIHAR 
7026748639

msadarsh256@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS PATNA  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 
Intervention  Pectoral nerve block(PEC) WITH Pecto intercoastal fascial block(PICF)   Group 2 patients will receive PEC BLOCK and PICF BLOCK. In PEC Block 20ml of 0.2% ropivacaine will be deposited between pectoralis minor and serratus anterior, 10ml of 0.2% ropivacaine in between pectoralis major and pectoral minor. PICF block 15ml of 0.2% ropivacaine will be deposited between the pectoralis major and external intercostal muscles. data will be collected 24 hours post operatively. 
Comparator Agent  Thoracic Paravertebral Block  Group 1 will receive 20ml of 0.2% ropivacaine in the paravertebral space of the surgical side after induction of general anaesthesia, data will be collected till first 24 hours postoperatively. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. Adult aged between 30-70 Yrs.
2. Posted for unilateral MRM
3. ASA I-II
 
 
ExclusionCriteria 
Details  1. Patients refusal
2. Sensitivity to LA
3. Bleeding disorders
4. patients on anticoagulants
5. BMI of more than 35 kg/m2
6. Spine/chest wall deformity
7. Pregnancy
8. Inability to understand NRS and PCA device use
9. Current chronic opioids use



 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Time for first rescue analgesia noted in minutes/hours
 
Not applicable
 
 
Secondary Outcome  
Outcome  TimePoints 
Postoperative morphine consumption in the first 24 hours  End of post operative 24 hour 
Post-operative NRS on rest and movement  0,1,2,4,6,12,24 hour post surgery  
Total opioid consumption  first 24 hour 
Complication
Patient satisfactory score 
end of 24th hour 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/08/2022 
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   nil 
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 frequent cancer among Indian women accounting for 25 to 32 per cent. Surgical resection of the primary tumour with axillary dissection is one of the most important therapeutic procedures for breast cancer. Most breast surgeries are done in general anaesthesia, with or without regional blocks. Forty per cent of women experience moderate to severe pain following breast cancer surgery in the first few days.

Various regional anaesthesia techniques including thoracic paravertebral block, Erector spinae plane block, PEC block etc. have been used for perioperative analgesia in breast cancer surgery to decrease opioid consumption and its side effect. Poor management of acute postoperative pain may lead to persistent postoperative pain with an incidence of 25 to 60% of patients. These blocks are found to be effective for postoperative analgesia and also decrease the incidence of post-mastectomy pain syndrome. The paravertebral block is considered the gold standard for breast surgery but this block is associated with many complications. Recently interfacial blocks (pectoral nerve blocks) have been used for post-op analgesia in breast surgery. 

This study aims to compare the efficacy of ultrasound-guided combined pectoral nerve block and pecto intercostal fascial block with thoracic paravertebral block for perioperative analgesia for MRM, and to find which requires less opioid consumption, better NRS, fewer complications, a better patient satisfactory score.

 
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