| 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
|
|
|
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
|
|
|
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. |