Transversus Abdominis Plane Block From Intraabdominal Approach in Patients Undergoing Total Abdominal Hysterectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- postoperative 24hr morphine consumption
研究概览
简要总结
Randomized double blind placebo controlled trial on transversus abdominus plane block approached from abdominal cavity, in patients undergoing total abdominal hysterectomy.
详细描述
Potential advantages compared to percutaneous approach are decrease in risk of visceral injury as it is under direct visual and tactile guidance, ease of approach in obese patients, short theatre time for administration, easy to administer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •ASA physical status I-III
- •Age 18 or above
- •Scheduled to undergo TAH+/- salpingoophorectomy.
- •Scheduled to receive general anaesthesia under standardized anaesthetic regime.
- •Comprehends how to use intravenous patient controlled analgesia (IV PCA).
- •Is willing to complete the postoperative assessment.
- •Understands the nature and purpose of this study and the study procedures and has signed the informed consent form for this study to indicate this understanding.
排除标准
- •Known allergy to drugs involved in this study
- •Previously taking medications thought to result in opioid tolerance, or analgesics thought to interfere with subsequent opioid requirement.
- •Undergoing any procedures in addition to TAH+/- salpingoophorectomy.
- •With co-existing pathology resulting in persistent pain requiring analgesics.
- •Wound incision extending to supra-umbilical level.
研究组 & 干预措施
0.5% Ropivacaine
group receiving TAP block (0.5% ropivacaine at TAP plane)
干预措施: Transversus abdominis plane block (Procedure)
normal saline
group receiving placebo (saline) at TAP plane
干预措施: Transversus abdominis plane block (Procedure)
结局指标
主要结局
postoperative 24hr morphine consumption
时间窗: 24 hours
The primary objective of this study is to demonstrate the effectiveness of tranversus abdominis plane block using the intraabdominal approach in reducing postoperative 24 hours morphine consumption after total abdominal hysterectomy (TAH) where time 0 is taken as time of arrival at PACU.
次要结局
- morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after.(24hrs)
- Degree on pain according to numerical pain score on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after during rest and movement (cough(24hrs)
- incidence of nausea and vomiting(24hours postoperatively)