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CTRI Number  CTRI/2019/01/016900 [Registered on: 04/01/2019] Trial Registered Prospectively
Last Modified On: 22/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Study to assess usefulness of placing catheter in the spinal column for pain relief in transgender patients undergoing sex change operation ( from man to women) 
Scientific Title of Study   ultrasound guided caudal catheter for post operative analgesia in gender re-assignment surgery. A descriptive surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Annie John 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute  
Address  Department of Anaesthesiology Second floor, D block Hospital complex, Mahatma Gandhi Medical College and Research Institute Pillayarkuppam

Pondicherry
PONDICHERRY
607402
India 
Phone  9655035791  
Fax    
Email  dr.anniej@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Annie John 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute  
Address  Department of Anaesthesiology Second floor, D block Hospital complex, Mahatma Gandhi Medical College and Research Institute Pillayarkuppam

Pondicherry
PONDICHERRY
607402
India 
Phone  9655035791  
Fax    
Email  dr.anniej@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Annie John 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute  
Address  Department of Anaesthesiology Second floor, D block Hospital complex, Mahatma Gandhi Medical College and Research Institute Pillayarkuppam

Pondicherry
PONDICHERRY
607402
India 
Phone  9655035791  
Fax    
Email  dr.anniej@yahoo.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Research Institute,Pondicherry 607402 
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College and Research Institute 
Address  Pillayarkuppam, Pondicherry 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 Annie John  Mahatma Gandhi Medical College and Research Institute  Department of Anaesthesiology Second floor, D block Hospital complex, Mahatma Gandhi Medical College and Research Institute Pillayarkuppam
Pondicherry
PONDICHERRY 
9655035791

dr.anniej@yahoo.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: F640||Transsexualism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  caudal analgesia  ultrasound guided caudal epidural catheter will be placed for transgender patients undergoing gender affirmation surgeries and post operative analgesia will be assessed 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  1.Female Transgender
2.Male to Female transition surgeries
3.Age 18 to 60 years
4. ASA I – II

 
 
ExclusionCriteria 
Details  1.Patient refusal
2.Spinal deformities
3.Patients allergic to local anaesthetics
4.Patients with coagulopathy
5.Patients with neurological deficits and neuromuscular diseases
6.Patients with infection at the site of injection
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Static and Dynamic Visual Numeric Rating Scale for pain  1, 2,4,6,8,12,24,36 and 72 hours in the postoperative period 
 
Secondary Outcome  
Outcome  TimePoints 
1.Total dose of local anaesthetics and additives
2.Total dose of rescue systemic analgesia
3. Ambulatory score
4. Procedure related complications like pain, infection 
1,2 and 3 postoperative day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="75" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/01/2019 
Date of Study Completion (India) 10/11/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Perineal and anorectal surgeries can cause severe postoperative pain and discomfort due to its dense nerve supply and sympathetic reflexes. Good postoperative analgesia is important for early rehabilitation and prevent chronic perineal or post- surgical pain. In gender re-assignment surgery, there is extensive surgical manipulation and reconstruction of the genitals and perineum leading to increased pain and discomfort.  The commonly practiced lumbar epidural block can produce inadequate analgesia and undue motor blockade, which can prevent early ambulation and rehabilitation of these patients. Hence, we aim to analyse postoperative analgesia via ultrasound guided caudal catheter for gender re-assignment surgeries in transgender patients. 

our aim is to assess the effectively of caudal analgesia via caudal epidural catheter for post-operative analgesia in gender re-assignment surgeries in Transgender patients 

Patient will be positioned in left lateral knee chest position. After strict aseptic precaution, Sonosite Xporte (Sonosite, Bothwell, WA) ultrasound system with multi-beam (compound array) capability and with high frequency linear array transducer (HFL 50, 15-10 MHz) will be used to perform the caudal block. The USG probe will be placed on the sacrum and scanned downward till the sacral hiatus is identified (Frog eye appearance). 18G touhy needle will be introduced in an out-plane approach towards the sacral hiatus and once the needle crosses the sacro-coccegyeal ligament (pop up), the skin epidural space distance will be noted and epidural catheter will be threaded till 5cms in epidural space. Distance of caudal space from skin, no of attempts to needle insertion, total duration for block performance will be documented. A test dose of 3 mL of 2 % lignocaine with 1 in 200000 adrenaline will be administered to rule out intravascular and intra-thecal placement of catheter.

 Spinal anaesthesia will be administered with 3 mL of 0.5 % hyperbaric bupivacaine through 25 G Quincke’s needle. Patient will be placed in supine position and sensory level assessed. After adequate level of anaesthesia is achieved, surgery will commence.Patient will be continuously monitored and hemodynamic parameters recorded every 5mins till the end of surgery.

Caudal catheter will be activated when sensory anaesthesia level descends to L1 dermatome with 10 cc of 0.2% ropivacaine with 1mcg /kg clonidine and the subsequent dose will be administered next day morning.  static and dynamic pain score, total local anaesthetic  and adjuvant consumption, ambulation and patient satisfaction score.

 The study will be terminated after the time frame of 6 months or a miminum of 30 patients are recruited 


 
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