Conscious Sedation With Suprainguinal Facia Iliaca Block Versus Ilioinguinal Iliohypogastric Block for Transcatheter Aortic Valve Implantation (TAVI)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The primary outcome is the timing to the first rescue analgesia
研究概览
简要总结
the aim of the present study is to compare suprainguinal fascia iliaca block and ilioinguinal-iliohypogastric (II-IH) nerve block in improving the quality of conscious sedation, including reducing patients' requirements for analgesia also better satisfaction for both patient and surgeon as regards patient outcome and decreasing the incidence of conversion to general anesthesia during TAVI procedure
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged >20 years with severe aortic stenosis undergoing elective, non-emergent, non-urgent transfemoral Sapien 3TM (Edwards Lifesciences Corp., Irvine, CA, USA) or CoreValveTM (Medtronic, Minneapolis, MN, USA) implantation were included in the study
排除标准
- •younger than 20 years
研究组 & 干预措施
Group I (F)
suprainguinal fascia iliaca block group (SIFIB)
干预措施: suprainguinal fascia iliaca block group (SIFIB) (Other)
Group II (I)
iliohypogastric and ilioinguinal group (IL-IH)
干预措施: iliohypogastric and ilioinguinal group (IL-IH) (Other)
Group III (C)
control group patients received infiltration of 0.5% 10ml bupivacaine and 1% 10 ml lidocaine in the groin at the site of puncture
干预措施: Local infiltration (Other)
结局指标
主要结局
The primary outcome is the timing to the first rescue analgesia
时间窗: Six months
sedation score (RASS), and pain (numerical rating scale \[NSR\] from 0 \[no pain\] to 10 \[unbearable pain\]) at 0 time start of sedation and every 30 min till the end of the procedure then 1, 3, and 6 h after TAVI. While, Pain intensity was assessed using numeric rating scale (NRS 0-10; 0 = no pain; 10 = the worth pains imaginable) in five time-points intraoperatively (femoral artery cannulation (1), aortic valve system introduction (2), aortic valve system removal (3), vessel closure devices insertion (4), the end of the operation (5)). In addition, the need for post TAVI pacing, vascular complications at the TAVI access site during admission, and the length of hospital stay were recorded. Rescue analgesia will be given When NRS was more than 4, patient discomfort or doctor dis-satisfaction is detected, 0.5 mic /kg fentanyl will be given. The primary outcome is the timing to the first rescue analgesia
次要结局
未报告次要终点
研究者
Mohammed Shabayek
Lecturer of Anesthesia, ICU and pain management
Ain Shams University