Lumbar Epidural Catheter Compared to Caudal Epidural Catheter for Postoperative Analgesia in Feminizing Genital Gender Affirmation Surgery. A Randomised Non Inferiorty Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- pain score- using verbal numerical rating score.
研究概览
简要总结
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 Signâ€), 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- Male
入选标准
- •Transgender patient posted for feminizing genital gender affirmation surgery ASA 1 and 11 Patient undergoing male to female surgery.
排除标准
- •Patient refusal Deranged coagulation profile Severe cardiac or pulmonary disease Spinal deformity Allergy to drugs in the study All contraindication to epidural analgesia.
结局指标
主要结局
pain score- using verbal numerical rating score.
时间窗: 0,2,4,6,8,10,12,24,36,48,72 hours postoperatively
次要结局
- Incidence of breakthrough pain(Degree of urinary catheter discomfort)
研究者
Gowtham S
Mahatma Gandhi Medical College and Research Institute
