The Comparison of Effectiveness Between Epidural Combined Bilateral US TAP Block Versus Epidural Alone for Gynaecology Operation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Pain score between epidural plus bilateral TAP block and epidural alone
研究概览
简要总结
The goal of this clinical trial is to compare effectiveness between epidural combined with TAP block versus epidural alone in gynaecology operation participant .The main question[s] it aims to answer are:
- what is the pain score for both groups
- what is the requirement of epidural infusion between the 2 groups Participants will be given general anesthesia for the operation with the epidural insertion prior to induction. Patient will be randomized into epidural plus TAP block or epidural alone for the study. The US TAP block will be given at the end of operation prior to extubation.
Researchers will compare pain score, epidural infusion requirment between the two groups.
详细描述
The research is a prospective randomized control study. It is blinded study as accessor is blinded whereby the acute pain service (APS) team will be reviewing patient postoperatively.
Study size of 46 subjects based on repeated measure ANOVA between factor , alpha value 0.05% with 80% power study, a dropout 10%. Divided into 2 groups ; Group E - epidural alone, Group T - epidural plus bilateral US TAP block.
Perioperatively, epidural catheter will be inserted then induction for general anesthesia given. Intraoperatively anesthesia maintain with inhalation agent. Prior to extubation, bilateral TAP block is provided using portable US guidance. At this location, the 3 layers of anterior abdominal wall is visualized for the truncal block. Post operatively, participant will be given epidural cocktail bupivacaine 0.1% + fentanyl 2mcg/ml infusion for next 24hrs.
The APS team will review patient post operatively in ward and all data will be recorded. Participation of patient's during study is approximately 2 days duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
APS team will be assessing participants pain score in the ward and documented the data.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elective major laparotomy gynaecology procedure.
- •Age 18 years and above
- •ASA I, II, III
排除标准
- •Prolonged INR
- •Allergic to LA
- •History of chronic pain
- •Psychological disorder/addict to opioid or benzodiazepine
- •Any contraindication for epidural or TAP block procedure
- •Pregnancy
结局指标
主要结局
Pain score between epidural plus bilateral TAP block and epidural alone
时间窗: Post operatively, until day 2 post operation.
To compare the pain score between 2 groups (epidural with bilateral TAP block) and epidural alone for gynaecology operation.
次要结局
- To compare the epidural infusion requirement between the 2 groups ( Group T and Group E)(Post operatively, until day 2 post operation.)
- To evaluate time of early mobilization between 2 groups ( Group T and Group E)(Post operatively, until day 2 post operation.)
研究者
Rhendra Hardy Mohamad Zaini
Prof Madya
Universiti Sains Malaysia