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CTRI Number  CTRI/2024/02/062869 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 19/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of comparison of posterior thoracic Plane Block in patients undergoing modified radical mastectomy for pain relief 
Scientific Title of Study   Comparison of analgesic efficacy of Erector Spinae Plane Block with combined Rhomboid Intercostal and Subserratus Plane Block in patients undergoing modified radical mastectomy: a randomized 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  Poonam Kumari 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences,Patna 
Address  Room-1,5th floor Ot complex,IPD block,AIIMS Patna
Department of anaesthesiology,5th floor Ot complex,IPD block,AIIMS Patna
Patna
BIHAR
801507
India 
Phone  7992418189  
Fax    
Email  drpoonam1981@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Athira Ramesh 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences,Patna 
Address  Room-11,5th floor Ot complex,IPD block,AIIMS Patna
Department of Anaesthesiology,5th floor Ot complex,IPD block,AIIMS Patna
Patna
BIHAR
801507
India 
Phone  9840604302  
Fax    
Email  athiraramesh18@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Athira Ramesh 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences,Patna 
Address  Room-11,5th floor Ot complex,IPD block,AIIMS Patna
Department of Anaesthesiolgy,5th floor Ot complex,IPD block,AIIMS Patna
Patna
BIHAR
801507
India 
Phone  9840604302  
Fax    
Email  athiraramesh18@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Patna 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences,Patna 
Address  Department of Anesthesiology, IPD building,OT complex. 
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 
Dr Poonam Kumari  All India Institute of Medical Sciences,Patna  Department of Anaethsiology,OT complex,IPD building,AIIMS Campus,Patna
Patna
BIHAR 
7992418189

drpoonam1981@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: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  US-guided Erector spinae Plane block using 20ml of 0.25%. Bupivacaine along with GA  Group I Will receive US-guided Erector spinae Plane block using 20ml of 0.25%. Bupivacaine along with GA 
Comparator Agent  US-guided rhomboid intercostal block combined with the sub-serratus plane block (RISS) using 20ml+20ml of 0.25% Bupivacaine along with GA  Group II will receive US-guided rhomboid intercostal block combined with the sub-serratus plane block (RISS) using 20ml+20ml of 0.25% Bupivacaine along with GA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients willing to give written informed consent 2. Aged 18-65 years
3. ASA I –II patients scheduled to undergo elective MRM surgery under GA

 
 
ExclusionCriteria 
Details   
 
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 
To compare the requirement of postoperative opioid consumption   To compare the requirement of postoperative opioid consumption  
 
Secondary Outcome  
Outcome  TimePoints 
1.Intraoperative opioid consumption
2.To determine time of first rescue analgesic administration
3.To measure average pain NRS score at 24 hour postoperatively period
4.Satisfaction score assessment
5. To evaluate any adverse effect
 
To measure average pain NRS score at 24 hour postoperatively period (30 minutes, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour)

 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/03/2024 
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="0"
Months="3"
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  

 Modified radical mastectomy (MRM) is the most common surgery for breast cancer that is associated with marked postoperative pain. Ultrasound guided fascial plane blocks have been rapidly incorporated into regional anesthesia practice. Fascial plane blocks are emerging to provide feasible, safe alternatives comparing to epidural analgesia for management of pain. The ultrasound guided rhomboid intercostal block combined with the subserratus plane block (RISS) is a novel analgesic technique recently described by Elsharkawy et al. There are only few case reports, RCT’s and observational studies carried out to study the efficacy of this block. We propose to conduct this randomized clinical trial to compare the analgesic efficacy of Erector spinae plane block with combined Rhomboid intercostal and sub serratus plane block in patient undergoing modified radical mastectomy.

 

Problem statement- MRM surgery involves extensive dissection results in severe pain and can lead to significant halted postoperative recovery if pain isn’t managed appropriately. Opioids are considered to be the mainstay for perioperative pain management, however its usage is associated with adverse effects like respiratory depression, postoperative nausea vomiting. Current practice includes performance of fascial plane blocks including PEC block, Paravertebral block, Erector spinae plane block.

 

Rationale – Peripheral nerve blocks are known to be effective for pain management during and after surgeries. The ultrasound guided Rhomboid Intercostal block combined with the Subserratus plane block (RISS) and Erector Spinae plane block (ESP) are safe and effective technique for multimodal pain management during perioperative period. Regional anaesthesia techniques, including ESP and RISS, provide targeted and prolonged analgesia while minimizing systemic opioid consumption. These techniques offer the advantage of reduced opioid-related side effects.Both techniques are the newer for postoperative pain management.

 

  Novelty- There are only few case reports, RCT’s and observational studies carried out to study the efficacy of this block. There is no RCT Comparing the analgesic efficacy of Erector Spinae Plane Block with combined Rhomboid Intercostal and Subserratus Plane Block in patients undergoing modified radical mastectomy.

 

Expected outcome and application –Analyze the analgesic efficacy of Erector Spinae Plane Block with combined Rhomboid Intercostal and Subserratus Plane Block in patients undergoing modified radical mastectomy. Reduced opioid consumption and better pain scores in adult patients undergoing modified radical mastectomy. This will facilitate to include this block as a part of multimodal analgesic regimen in routine practice in our set up in this subset of patients.

 

Research question(s) - Is ultrasound guided Rhomboid Intercostal combined with Subserratus plane Block (RISS) better analgesic technique than Erector Spinae Plane block with less adverse effects in patients undergoing modified radical mastectomy (MRM)?

 

Research hypothesis (es): We hypothesize that the analgesic efficacy of Rhomboid Intercostal combined with Subserratus plane Block (RISS) would be better than Erector Spinae Plane (ESP) for patients undergoing MRM surgery.

 
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