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CTRI Number  CTRI/2022/11/047037 [Registered on: 04/11/2022] Trial Registered Prospectively
Last Modified On: 31/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pain relief with blockade of nerves between serratus muscles or rhomboid intercostal muscles in patients undergoing breast cancer surgery  
Scientific Title of Study   Comparison between ultrasound guided serratus anterior plane block and rhomboid intercostal plane block for postoperative analgesia in patients undergoing modified radical mastectomy- A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yuireishang Eshidang 
Designation  PG student 
Affiliation  Department of Anaesthesia, Lady Hardinge Medical College 
Address  Department of Anaesthesiology Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi

Central
DELHI
110001
India 
Phone  8414024722  
Fax    
Email  eshidangyuri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Maitree Pandey 
Designation  Director Professor 
Affiliation  Department of Anaesthesia, Lady hardinge Medical College 
Address  Department of Anaesthesiology Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi

Central
DELHI
110001
India 
Phone  9810570515  
Fax    
Email  Maitreepandey@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nishant Kumar 
Designation  Professor 
Affiliation  Department of Anaesthesia, Lady Hardinge Medical College 
Address  Department of Anaesthesiology Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi

Central
DELHI
110001
India 
Phone  9811934659  
Fax    
Email  kumarnishant@yahoo.co.uk  
 
Source of Monetary or Material Support  
Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, New-Delhi 110001 
 
Primary Sponsor  
Name  Lady Hardinge Medical College 
Address  Department of Anaesthesiology Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi 
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 
Yuireishang Eshidang  Lady Hardinge Medical College  Main Operation Theatre, Department of Anaesthesiology Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi
Central
DELHI 
8414024722

eshidangyuri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Human Research LHMC  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  Rhomboid intercostal plane block  Pre-operative USG guided rhomboid intercostal plane block will be administered before the surgery begin. 
Comparator Agent  Serratus anterior plane block  Pre-operative USG guided serratus anterior plane block will be administered before the surgery begin. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age more than 18 years of either sex planned for modified radical mastectomy 
 
ExclusionCriteria 
Details  Any known drug allergies and contraindication to nerve block like coagulopathy, bleeding diathesis and local site infection  
 
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 
Comparison of mean opioid consumption (in morphine equivalent mg/kg) at first 24 hours postoperatively in both the groups  24 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Median NRS at 0, 3,6,12 and 24 hours postoperatively
Mean duration of analgesia (in minutes)
Total number of skin puncture to perform the block
Mean duration taken (in minutes) for completion of block
Proportion of patients developing complications related to block like hematoma, pleural puncture and winging of scapula 
24 hours postoperatively 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   07/11/2022 
Date of Study Completion (India) 26/01/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="4"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none as yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Surgery on the chest wall is relatively common and can be associated with considerable postoperative discomfort and pain. Breast cancer is a common cancer affecting women, accounting for 31% of all new cancer cases1,2. Modified radical mastectomy (MRM), commonly performed in patients of breast cancer, causes significant acute pain in 8-25% of patients and if not treated adequately may progress to chronic pain states in 25–60% of cases3. Regional blocks for breast surgery reduce post-operative pain, opioid requirement, nausea and vomiting and duration of stay in post anesthesia care unit4.

Various regional anesthesia techniques with varying efficacy have been described for management of post-operative pain following breast surgery. These include thoracic epidural or paravertebral block, intercostal nerve block, pectoral nerve blocks and the newer USG guided fascial plane blocks like serratus anterior plane block (SAP) and rhomboid intercostal plane block (RIPB)5.

 

Serratus anterior plane block (SAP) was first proposed by Blanco et al in 2013, and provides good postoperative analgesia after MRM. It blocks T2-T9 intercostal nerves and provides analgesia over the chest wall and axillary region6. It has shown to reduce postoperative opioid consumption7.

 

Rhomboid intercostal plane block (RIPB) is a new fascial block technique described by Elsharkawy et al8 in 2016. RIPB is easier and can be performed reliably with the point of entry away from the involved/ surgical area. The block provides analgesia for the anterior and posterior thorax and has been studied extensively for thoracic surgeries. However, it has not been studied much for MRM, but the few available studies have reported enhanced recovery and decreased opioid consumption after mastectomy9.

Although SAP block has been extensively studied for breast surgery, RIPB in spite of being efficacious for post-operative analgesia after major thoracic surgery, is still under-evaluated for MRM. Though they have been compared with different blocks, literature is sparse with regards to the comparable analgesic efficacy of SAP and RIPB in MRM. This study is therefore being planned to compare the efficacy of the two blocks in MRM.


 
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