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CTRI Number  CTRI/2023/12/060443 [Registered on: 04/12/2023] Trial Registered Prospectively
Last Modified On: 03/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A COMPARATIVE STUDY OF OF EFFICACY OF ULTRASOUND GUIDED SUPERFICIAL SERRATUS ANTERIOR PLANE BLOCK VS DEEP SERRATUS ANTERIOR PLANE BLOCK FOR POSTOPERATIVE ANALGESIA IN PATIENTS UNDERGOING MASTECTOMY. 
Scientific Title of Study   A COMPARATIVE STUDY OF ULTRASOUND GUIDED SUPERFICIAL SERRATUS ANTERIOR PLANE BLOCK VS DEEP SERRATUS ANTERIOR PLANE BLOCK FOR POSTOPERATIVE ANALGESIA IN PATIENTS UNDERGOING MASTECTOMY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR ROHIT HALLI 
Designation  Junior Resident 
Affiliation  VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES 
Address  Room No. 5, Ground Floor, Department of Anaesthesia, VIMS OT Complex, VIMS, Cantonment, Ballari

Bellary
KARNATAKA
583104
India 
Phone  7676349223  
Fax    
Email  rohithalliglb@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SRINIVASALU D 
Designation  Professor and HOD, Department of Anaesthesia, VIMS, Ballari 
Affiliation  VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES 
Address  Room NO. 5, Ground Floor, Department of Anaesthesia, VIMS OT Complex, VIMS, Cantonment, Ballari

Bellary
KARNATAKA
583104
India 
Phone  9845224880  
Fax    
Email  drsrinivasd@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR ROHIT HALLI 
Designation  Junior Resident 
Affiliation  VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES 
Address  Room No. 5, Ground Floor, Department of Anaesthesia, VIMS OT Complex, VIMS, Cantonment, Ballari

Bellary
KARNATAKA
583104
India 
Phone  7676349223  
Fax    
Email  rohithalliglb@gmail.com  
 
Source of Monetary or Material Support  
Room No. 5, Ground Floor, Department of Anaesthesia, VIMS OT Complex, VIMS, Cantonment, Ballari 
 
Primary Sponsor  
Name  VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES 
Address  Room No. 5, Ground Floor, Department of Anaesthesia, VIMS OT Complex, VIMS, Cantonment, Ballari 
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 ROHIT HALLI  VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES   Room No. 5, Ground Floor, Department of Anaesthesia, VIMS OT Complex, VIMS, Cantonment, Ballari
Bellary
KARNATAKA 		 7676349223

rohithalliglb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES, BALLARI.  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  SERRATUS ANTERIOR PLANE BLOCK  DEEP VS SUPERFICIAL SERRATUS ANTERIOR PLANE BLOCK FOR POSTOPERATIVE ANALGESIA, DOSE 0.25% Bupivacaine 30ml, single dose, USG guided injection, Duration - 5-8mins 
Comparator Agent  SUPERFICIAL VS DEEP SERRATUSANTERIOR PLANE BLOCK  DURATION POSTOPERATIVE ANALGESIA IN PATIENTS UNDERGOING MASTECTOMY BY USG GUIDED TECHNIQUE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  PATIENTS OF 18-70 YEARS OF AGE, OF EITHER SEX, POSTED FOR ELECTIVE MASTECTOMY UNDER GENERAL ANAESTHESIA
PATIENTS WITH NORMAL CARDIOPULMONARY FUNCTION
ASA PHYSICAL STATUS 1 AND 2 
 
ExclusionCriteria 
Details  REFUSAL BY THE PATIENTS
PATIENTS WITH DERANGED COAGULATION PROFILE OR HAVING BLEEDING DIATHESIS
PATIENTS WITH OPIOID CONSUMPTIONS PREOPERATIVELY
HISTORY PF LOCAL INFECTION AND CHEST WALL DEFORMITIES
PATIENTS WITH FAMILY HISTORY OF NEURAL DISEASES
PATIENTS WITH ALLERGY TO STUDY DRUGS 
 
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 
DURATION OF POSTOPERATIVE ANALGESIA  24hours 
 
Secondary Outcome  
Outcome  TimePoints 
TIME OF FIRST RESCUE ANALGESIA
TOTAL DOSE OF RESCUE ANALGESIA IN FIRST 24 HOURS POSTOPERATIVE HOURS
NAUSEA, VOMITING, RESPIRATORY DEPRESSION AND OTHER COMPLICATIONS ASSOCIATED WITH PROCEDURE 		 24 hours 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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 3/ Phase 4 
Date of First Enrollment (India)   17/12/2023 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rohithalliglb@gmail.com].

  6. For how long will this data be available start date provided 25-06-2025 and end date provided 22-06-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Breast Surgery is increasingly common in women. Surgical incision at the breast and axillary areas is associated with significant pain, with high incidence of acute pain progressing to chronic pain in 25-60% of patients. Post-mastectomy pain managed solely with opioids often leads to side effects of nausea and vomiting, respiratory depression. Therefore, regional analgesic techniques are advocated for effective pain management as they have opioid sparing effect.

Much data has supported the efficacy of paravertebral blocks in thoracic analgesia, however they are not without risks. In recent years, there has been a need for simple, safe, and effective plane block, and the serratus anterior plane block is one that provides ipsilateral anesthesia of the hemithorax and is known to produce better post op analgesia over other blocks. Deep serratus anterior plane block is the recently described and associated with better NRS scores for pain on rest and coughing and prolonged duration of analgesia after modified radical mastectomy than that of superficial anterior plane block.

However, comparative studies of analgesic efficacy of superficial and deep serratus anterior plane blocks remains limited and hence this study was undertaken.

 
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