FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/087847 [Registered on: 28/05/2025] Trial Registered Prospectively
Last Modified On: 28/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of patient satisfaction with thoracic segmental spinal anaesthesia vs general anaesthesia for gynecomastia surgeries. 
Scientific Title of Study   Comparison of patient satisfaction with thoracic segmental spinal anaesthesia with modified tumescent solution vs general anaesthesia with standard tumescent solution for liporeduction of gynecomastia: A Randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Garee 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS) Bibinagar 
Address  Room no G 42, Ground floor Department of Anaesthesiology All India Institute of Medical Sciences (AIIMS) Bibinagar Hyderabad Metropolitan Region Telangana

Hyderabad
TELANGANA
508126
India 
Phone  9989421851  
Fax    
Email  drsandeep189@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Garee 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS) Bibinagar 
Address  Room no G 42, Ground floor Department of Anaesthesiology All India Institute of Medical Sciences (AIIMS) Bibinagar Hyderabad Metropolitan Region Telangana

Hyderabad
TELANGANA
508126
India 
Phone  9989421851  
Fax    
Email  drsandeep189@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sandeep Garee 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS) Bibinagar 
Address  Room no G 42, Ground floor Department of Anaesthesiology All India Institute of Medical Sciences (AIIMS) Bibinagar Hyderabad Metropolitan Region Telangana

Hyderabad
TELANGANA
508126
India 
Phone  9989421851  
Fax    
Email  drsandeep189@gmail.com  
 
Source of Monetary or Material Support  
Dr. Sandeep Garee Associate Professor All India Institute of Medical Sciences (AIIMS) Bibinagar Hyderabad Metropolitan Region Telangana 
 
Primary Sponsor  
Name  Dr. Sandeep Garee 
Address  All India Institute of Medical Sciences (AIIMS) Bibinagar Hyderabad Metropolitan Region Telangana 
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 Sandeep Garee  AIIMS Bibinagar  Room no G 42, Ground floor Department of Anaesthesiology Bibinagar HYderabad Metropolitan Region Telangana
Hyderabad
TELANGANA 
09989421851

drsandeep189@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitonal Ethics Committe - AIIMS BBN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M799||Soft tissue disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  General anaesthesia with standard tumescent solution   Routine general anaesthesia will be provided with Fentanyl, Propofol and Atracurium. Standard tumescent solution - 15ml of 2% Lignocaine, 10ml of 0.5% Bupivacaine, 1ml –Adrenaline 1:1000 and 5ml of 7.5% Sodium bicarbonate to one litre of ringer lactate will be used here.  
Intervention  Thoracic segmental spinal anaesthesia with modified tumescent solution  Spinal anaesthesia will be given with 5mg of isobaric levobupivacaine plus 25mcg fentanyl. Modified tumescent solution contains - 1ml –Adrenaline 1:1000 and 5ml of 7.5% Sodium bicarbonate to one litre of ringer lactate 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients coming for gynecomastia surgeries.
2. ASA 1-2
 
 
ExclusionCriteria 
Details  1. Allergy to local anaesthetics
2. Contraindications to spinal anesthesia
3. Cardiac abnormalities (Mitral and Aortic stenosis, CAD etc)
4. ASA 3,4 and 5
5. Patients refusal
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To compare the patient satisfaction of using SSA vs GA in patients undergoing liporeduction for gynecomastia surgeries.
2. To study the time to first rescue analgesia between segmental spinal anaesthesia vs GA for liporeduction in gynecomastia surgeries.

 
4 hours , 8 hours , 12 hours and 24 hours after the intervention 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess & compare the surgeon satisfaction of using SSA vs GA in patients undergoing liporeduction for gynecomastia surgeries  Immediately after the surgery 
2. To compare the incidence of PONV among both the groups  24 hours  
3. To compare the incidence of hemodynamic variations among the groups  Every 5 min until end of Surgery & then every 15 min for next 3 hours. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   16/06/2025 
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="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 - NO
Brief Summary  

Gynecomastia is a most common condition affecting male breast due to enlargement of both ductal and stromal tissue. Corrective surgery is the only solution for long standing gynecomastia, and it includes open excision, conventional liposuction, or combination of these if required under local (tumescent) or general anaesthesia. Segmental spinal anaesthesia (SSA) to block only the thoracic segments can also be given for breast surgeries and there are numerous advantages such as Avoidance of airway manipulation, polypharmacy, lesser risk of PONV, lesser chances of hypotension, able to achieve adequate muscle relaxation without respiratory or circulatory depression. Using modified tumescent solution (removing lignocaine and bupivacaine) we can eliminate the possibility of Local anaesthesia systemic toxicity (LAST) while analgesia will be provided by SSA. Our Primary objective is to compare the patient satisfaction of using SSA vs GA in patients undergoing liporeduction for gynecomastia surgeries and our secondary Objectives are to assess and compare the surgeon satisfaction of using SSA vs GA in patients undergoing liporeduction for gynecomastia surgeries, to compare the incidence of PONV among both the groups and to compare the incidence of hemodynamic variations among the groups. This is a pilot study, where we want to find the feasibility of using the modified tumescent solution. We will include 20 patients in SSA and 20 patients in GA group. Hence, we would like to compare patient satisfaction with thoracic segmental spinal Anaesthesia using modified tumescent solution vs General Anaesthesia using standard tumescent solution for liporeduction of gynecomastia.

 
Close