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)
- Conditions
- Transsexualism,
- Registration Number
- CTRI/2019/01/016900
- 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 toassess the effectively of caudal analgesia via caudal epidural catheter forpost-operative analgesia in gender re-assignment surgeries in Transgenderpatients
Patient will be positioned in left lateralknee chest position. After strictaseptic precaution, Sonosite Xporte (Sonosite, Bothwell, WA) ultrasound systemwith multi-beam (compound array) capability and with high frequency lineararray 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 sacralhiatus is identified (Frog eye appearance). 18G touhy needle will be introducedin an out-plane approach towards the sacral hiatus and once the needle crossesthe sacro-coccegyeal ligament (pop up), the skin epidural space distance willbe noted and epidural catheter will be threaded till 5cms in epidural space. Distanceof caudal space from skin, no of attempts to needle insertion, total durationfor block performance will be documented. A test dose of 3 mL of 2 % lignocainewith 1 in 200000 adrenaline will be administered to rule out intravascular andintra-thecal placement of catheter.
Spinal anaesthesia will be administered with 3mL of 0.5 % hyperbaric bupivacaine through 25 G Quincke’s needle. Patient willbe placed in supine position and sensory level assessed. After adequate levelof anaesthesia is achieved, surgery will commence.Patientwill be continuously monitored and hemodynamic parameters recorded every 5minstill the end of surgery.
Caudal catheter will be activated whensensory anaesthesia level descends to L1 dermatome with 10 cc of 0.2%ropivacaine with 1mcg /kg clonidine and the subsequent dose will be administerednext 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 30
- 1.Female Transgender 2.Male to Female transition surgeries 3.Age 18 to 60 years 4.
- ASA I – II.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 1.Total dose of local anaesthetics and additives 2.Total dose of rescue systemic analgesia
Trial Locations
- Locations (1)
Mahatma Gandhi Medical College and Research Institute
🇮🇳Pondicherry, PONDICHERRY, India
Mahatma Gandhi Medical College and Research Institute🇮🇳Pondicherry, PONDICHERRY, IndiaDr Annie JohnPrincipal investigator9655035791dr.anniej@yahoo.com