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
|
|
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
|
|
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
|