FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/065833 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 08/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare two techniques of analgesic drug injection in the spinal column for post surgery pain relief in transgender patients undergoing sex change operation. 
Scientific Title of Study   Lumbar Epidural Catheter Compared to Caudal Epidural Catheter for Postoperative Analgesia in Feminizing Genital Gender Affirmation Surgery. A Randomised Non Inferiorty 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  Gowtham S 
Designation  Post Graduate 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Anaesthesiology, Second floor, operation theatre complex Mahatma Gandhi Medical College and Research Institute Pondicherry- Cuddalore road,ECR, Pillayarkuppam, Puducherry 607402
No.28 third cross street, Ansari Duraisamy Nagar, Mudaliarpet Puducherry
Pondicherry
PONDICHERRY
607402
India 
Phone  8667865249  
Fax    
Email  gowthamsundar2022@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Annie Sheeba J 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College and Research Instituite 
Address  Department of Anaesthesiology, Second floor, operation theatre complex Mahatma Gandhi Medical College and Research Institute Pondicherry- Cuddalore road,ECR, Pillayarkuppam, Puducherry 607402

Pondicherry
PONDICHERRY
607402
India 
Phone  9655035791  
Fax    
Email  dr.anniej@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Gowtham S 
Designation  Post Graduate 
Affiliation  Mahatma Gandhi Medical College and Research Instituite 
Address  Department of Anaesthesiology, Second floor, operation theatre complex Mahatma Gandhi Medical College and Research Institute Pondicherry- Cuddalore road,ECR, Pillayarkuppam, Puducherry 607402
Pondicherry- Cuddalore road,ECR, Pillayarkuppam, Puducherry 607402
Pondicherry
PONDICHERRY
607402
India 
Phone  8667865249  
Fax    
Email  gowthamsundar2022@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi medical college research institute 
 
Primary Sponsor  
Name  Mahatma Gandhi medical college research institute 
Address  Pondicherry-cuddalore road,ECR Pillayarkuppam, Puducherry 607402 
Type of Sponsor  Private 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 Gowtham  Mahatma Gandhi Medical college and research institute  Department of anaesthesiology second floor Operation theatre complex MGMCRI Pondicherry cuddalore road ECR Pillayarkuppam Puducherry 607402
Pondicherry
PONDICHERRY 		 8667865249

gowthamsundar2022@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human 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, (2) ICD-10 Condition: N538||Other male sexual dysfunction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  caudal Epidural analgesia   caudal epidural analgesia with local anaesthetic drug given for pain relief in transgender patients. The analgesic profile will be monitored from postoperative day 0 to postoperative day 1 (3 days ) 
Intervention  lumbar epidural analgesia  lumbar epidural analgesia with local anaesthetic given for pain relief in transgender patients. The analgesic profile will be monitored from postoperative day 0 to postoperative day 1 (3 days ) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  Transgender patient posted for feminizing genital gender affirmation surgery
ASA 1 and 11
Patient undergoing male to female surgery
 
 
ExclusionCriteria 
Details  Patient refusal
Deranged coagulation profile
Severe cardiac or pulmonary disease
Spinal deformity
Allergy to drugs in the study
All contraindication to epidural analgesia
 
 
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 
pain score- using verbal numerical rating score.
 		 0,2,4,6,8,10,12,24,36,48,72 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of breakthrough pain
Degree of urinary catheter discomfort
Functional outcome assessment
 		 0,2,4,6,8,10,12,24,36,48,72 hours 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/07/2024 
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   Good postoperative analgesia is important for early rehabilitation and prevent chronic perineal or post- surgical pain
Theoretically, a caudally directed epidural catheter passed via the lumbar interspace can block the sacral plexus and provide effective analgesia in genital surgeries. Hence, this study is designed to assess the non-inferiority of lumbar epidural catheters to caudal epidural catheters for postoperative analgesia in feminizing gender affirmation surgery.
Once the patient is positioned in the left lateral positioned, the L4-L5 space will be identified using Ultrasound guidance. Once the patient is positioned in the left lateral positioned, under aseptic precautions HFL 50 USG probe will be placed in a transverse plane on the sacral cornua and the sacral hiatus will be identified (“Frog Eye Sign”), 2ml of lignocaine with adrenaline with be infiltrated subcutaneously.

After receiving epidural, patient will receive spinal anaesthesia at L3-L4 level as per departmental protocol. Intraoperative anaesthetic management will be as per the discretion of the primary OT anaesthesia team. 

At the end of the surgery patient will be shifted to post anesthesia care unit and will be monitored for analgesic requirements. Patient will receive monitored for post anesthesia care unit. Patient will receive epidural top-up (fixed schedule regime) as per the acute pain service protocol.

The pain score will be recorded on a VNRS scale of 0-10, at 0,2, 4, 6, 8, 12, 14, 36, 48 and 72 hours postoperative. Number of breakthrough pain, need for rescue analgesia, catheter congruency, urinary catheter discomfort and functional outcome assessment will be recorded for both groups.

Intravenous Pethidine 1mg/kg will be given as rescue analgesia if VNRS > 4, in between the scheduled top-ups.

 

 
Close