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CTRI Number  CTRI/2022/04/041615 [Registered on: 04/04/2022] Trial Registered Prospectively
Last Modified On: 29/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Two ways of giving erector spinae plane block for pain relief after surgery in patients undergoing breast surgeries 
Scientific Title of Study   Parasagittal versus transverse approaches of erector spinae plane block for post operative 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  Anshu Gupta 
Designation  Professor 
Affiliation  Lady hardinge medical college 
Address  Department of anaesthesia, lady hardinge medical college cannaught place

Central
DELHI
110001
India 
Phone  9711000264  
Fax    
Email  anug71@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Sakshi Kiran 
Designation  Post graduate 
Affiliation  Lady hardinge medical college 
Address  Department of anaesthesia, lady hardinge medical college cannaught place

Central
DELHI
110001
India 
Phone  6200612553  
Fax    
Email  sakshikiran003@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nitin Hayaran 
Designation  Professor 
Affiliation  Lady hardinge medical college 
Address  Department of anaesthesiology, Lady hardinge medical college cannaught place

Central
DELHI
110001
India 
Phone  9315175494  
Fax    
Email  nhayaran97@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Lady hardinge medical college Shaheed bhagat singh marg, cannaught place, new delhi 
 
Primary Sponsor  
Name  Lady Hardinge Medical College 
Address  Shaheed bhagat singh marg, cannaught place , 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 
Sakahi Kiran  Lady hardinge medical college  Department of anaesthesiology, Lady hardinge medical college,New delhi
Central
DELHI 		 6200612553

sakshikiran003@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast, (2) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Parasagittal approach of Erector Spinae Plane block  USG guided parasagittal approach of erector spinae plane block using 22G 80mm needle at T3 level 
Intervention  Transverse approach of Erector Spinae Plane Block  USG guided transverse approach of erector spinae plane block using 22G 80mm needle at T3 level 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All adult patients planned for modified radical mastectomy. 
 
ExclusionCriteria 
Details  1.Any known allergy to the drugs used
2.Contraindication to nerve block like coagulopathy,bleeding diathesis and local infections 
 
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 
Mean opioid consumption (in mg/kg) at 24 hours postoperatively in both the groups  at 24 hour post-operatively 
 
Secondary Outcome  
Outcome  TimePoints 
1. Total number of skin puncture to perform the block.
2. Proportion of patients developing complications related to block like hematoma, pleural puncture etc
3. Mean duration in minutes taken for completion of block from initial needle entry to completion of block.
4. Numerical rating scale (NRS) at 0,6,12 and 24 hours postoperatively. 		 0, 6, 12 and 24 hours
 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   08/04/2022 
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="1"
Days="20" 
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   Modified radical mastectomy (MRM) is most common type of surgery performed in patients of breast cancer. Regional blocks for breast surgery have reduced post-operative pain score, reduced opioid requirement, decrease post-operative nausea and vomiting and decrease duration of stay in post anesthesia care unit. 
Various regional anesthesia techniques have been described for management of post-operative pain following breast surgery like epidural administration, thoracic paravertebral block, intercostal block, brachial plexus block, pectoral nerve block, serratus anterior block and recently described erector spinae plane block (ESPB).
ESPB is a recently described ultrasound guided technique for management of acute and chronic thoracic pain. In this block, local anesthetic is injected deep to erector spinae muscle which results in blocking of ventral and dorsal rami of spinal nerve. ESPB is safe and efficacious for pain management of most of the thoracic wall structures including MRM. 
Parasagittal approach of ESPB is commonly used , however identification of tip of transverse process is difficult in this approach and may lead to block failure. Recently transverse approach of ESPB has been described in which needle can be accurately positioned at the tip of transverse process. This approach also has less risk of the puncture of the lung or other visceral organs.
 
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