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临床试验/CTRI/2019/01/016900
CTRI/2019/01/016900已完成不适用

ultrasound guided caudal catheter for post operative analgesia in gender re-assignment surgery.A descriptive surgery

Mahatma Gandhi Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月15日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Static and Dynamic Visual Numeric Rating Scale for pain

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Male

入选标准

  • 1.Female Transgender 2.Male to Female transition surgeries 3.Age 18 to 60 years
  • ASA I – II.

排除标准

  • 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.

结局指标

主要结局

Static and Dynamic Visual Numeric Rating Scale for pain

时间窗: 1, 2,4,6,8,12,24,36 and 72 hours in the postoperative period

次要结局

  • 1.Total dose of local anaesthetics and additives(2.Total dose of rescue systemic analgesia)

研究者

申办方类型
Private medical college

研究点 (1)

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