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CTRI Number  CTRI/2025/03/081732 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 12/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   a study to evaluate efficacy of serratus anterior plane block in modified radical mastectomy surgeries 
Scientific Title of Study   A Prospective randomized study to evaluate efficacy of Serratus Anterior Plane block in addition to multimodal analgesia for perioperative opioid sparing in patients undergoing modified radical mastectomy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Srikanth Kakunoor 
Designation  Postgraduate 
Affiliation  Nizams Institute of Medical Sciences 
Address  Department of Anesthesiology, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India

Hyderabad
TELANGANA
500082
India 
Phone  7732061128  
Fax    
Email  ksksrikanth2096@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shibani Padhy 
Designation  Additional Professor 
Affiliation  Nizams Institute of Medical Sciences 
Address  Department of Anesthesiology, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India

Hyderabad
TELANGANA
500082
India 
Phone  8332921975  
Fax    
Email  drshibanipadhy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Srikanth Kakunoor 
Designation  Postgraduate 
Affiliation  Nizams Institute of Medical Sciences 
Address  Department of Anesthesiology, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India


TELANGANA
500082
India 
Phone  7732061128  
Fax    
Email  ksksrikanth2096@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India - 500082 
 
Primary Sponsor  
Name  Nizams Institute of Medical Sciences 
Address  Department of Anesthesiology, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India - 500082 
Type of Sponsor  Research institution and hospital 
 
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 Srikanth K  Nizams Institute of Medical Sciences  Department of Anesthesiology, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India - 500082
Hyderabad
TELANGANA 		 7732061128

ksksrikanth2096@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nizams Institutional Ethics Committee  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 
Comparator Agent  gabapentin   Oral Gabapentin 400mg will be given 2 hours prior to surgery as a single dose for 24 hours. if in the postoperative period, numeric rating scale for pain is more than 4, then intravenous inj. tramadol 1mg/kg will be given so as to not to exceed the dose of tramadol of upto 400mg in 24 hours. 
Intervention  gabapentin plus usg guided serratus anterior plane block  Oral Gabapentin 400mg 2 hours prior to surgeryas a single dose in 24 hours, plus single shot USG guided Serratus Anterior Plane Block after induction of general anesthesia but before initiation of surgery with bupivacaine 0.25% at 0.4ml/kg body weight dose. if in the postoperative period, numeric rating scale for pain is more than 4, then intravenous inj. tramadol 1mg/kg will be given so as to not to exceed the dose of tramadol of upto 400mg in 24 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  ASA 1 & 2 Patients with carcinoma breast posted for modified radical mastectomy 
 
ExclusionCriteria 
Details  ASA 3 and above patients, denial of consent for the procedure, previous allergic history to anaesthetic drugs, coagulopathy, patients with fungating breast malignancy with distant metastasis, patients on anticoagulation, pregnant women, gross abnormality in the anatomy of chest wall due to malignancy, severe cardiac, respiratory and neurological dysfunction 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
compare postoperative opioid consumption requirement between the groups  at 1hr, 2hr, 6hr, 12hr, 24hr after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
incidence of postoperative nausea and vomiting(PONV), time to first opioid demand, functional activity score at rest and on arm abduction.  at 1hr, 2hr, 6hr, 12hr, 24hr after surgery. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   17/03/2025 
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="6"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ksksrikanth2096@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Beginning 9 months and ending 36 months following article publication.

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

Introduction: 

Despite the implementation of novel surgical techniques and multimodal analgesia regimens,nearly 60% of breast surgery patients experience severe acute postoperative pain(1).   

A poorly controlled perioperative pain management strategy on this surgical population, may result in delayed functional recovery, delayed post anesthesia care unit (PACU) discharge and/or extended length of hospital stay .In addition, inadequate postoperative pain management is recognized as one of the most relevant risk factors for the development of chronic postoperative breast pain(2). Serratus Anterior Plane (SAP)  block is a safe and effective method to treat postoperative pain after breast surgery(3). It  primarily targets the thoracic intercostal nerves (T2-T8), providing complete analgesia to the antero- lateral part of the thorax.There are few publications evaluating its effectiveness in conjunction with multimodal analgesia (MMA) in pain management and opioid sparing effect after modified radical mastectomy (MRM). Multimodal analgesia (MMA) is a strategy that aims to reduce reliance on opioids, and involves the use of two or more drugs that have different mechanisms of action to provide adequate analgesia. In the recent times there has been an increasing emphasis on use of multimodal analgesia (MMA), particularly in the context of postoperative enhance recovery after surgery (ERAS) protocols, reducing perioperative opioid consumption and, subsequently, their side effects(4). The use of oral gabapentinoids and acetaminophen alone or in conjunction with regional anesthesia as part of multimodal analgesia(MMA), has shown an adequate reduction on pain scores and opioid consumption(5). Therefore, our study hypothesized that the use of a serratus anterior plane (SAP) block in combination with multimodal analgesia (MMA) will reduce perioperative opioid consumption in patients undergoing modified radical mastectomy ( MRM).

 
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