Pain Control With Ultrasound-guided Ilioinguinal Iliohypogastric Nerve Block Compared With Local Anesthesia Infiltration in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation (TF-TAVI): a Prospective, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale (NRS)
研究概览
简要总结
Ilioinguinal and iliohypogastric (ILIH) nerve blocks are frequently performed for analgesia in inguinal surgery.
The investigators hypothesized that preoperative ultrasound-guided ilioinguinal and iliohypogastric (ILIH) nerve blocks will produce better intraoperative analgesia and less analgesic requirement postoperatively in comparison to commonly used preoperative local infiltration anaesthesia for patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI).
详细描述
It is a prospective, randomized trial.
The patients will be randomized to one of the 2 groups:
Group 1 - NERVE BLOCK. Ultrasound-guided ILIH nerve block will be performed by attending anaesthesiologist.
Group 2 - LOCAL INFILTRATION. Local anaesthetic infiltration of the operative area will be performed by operator.
During surgery patients will receive low-dose propofol infusion in order to achieve conscious sedation level, when indicated.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with aortic valve stenosis referred for TF-TAVI
- •using a minimalist approach of local anesthesia or nerve block with conscious sedation
排除标准
- •patient's refusal to participate
- •allergy to local anaesthetic
- •TF-TAVI requiring general anesthesia or surgical cut-down
- •patients with major cognitive impairment and inability to assess their pain level in Numerical Rating Scale (NRS).
研究组 & 干预措施
Nerve block
ultrasound-guided ilioinguinal iliohypogastric nerve block performed by the anaesthesiologist for Transaortic valve implantation (TAVI) insertion with eventual additional intraoperative analgesia (AIA) and/or additional postoperative analgesia (APA)
干预措施: Nerve block (Procedure)
Nerve block
ultrasound-guided ilioinguinal iliohypogastric nerve block performed by the anaesthesiologist for Transaortic valve implantation (TAVI) insertion with eventual additional intraoperative analgesia (AIA) and/or additional postoperative analgesia (APA)
干预措施: TAVI (Procedure)
Nerve block
ultrasound-guided ilioinguinal iliohypogastric nerve block performed by the anaesthesiologist for Transaortic valve implantation (TAVI) insertion with eventual additional intraoperative analgesia (AIA) and/or additional postoperative analgesia (APA)
干预措施: Additional intraoperative analgesia (Drug)
Nerve block
ultrasound-guided ilioinguinal iliohypogastric nerve block performed by the anaesthesiologist for Transaortic valve implantation (TAVI) insertion with eventual additional intraoperative analgesia (AIA) and/or additional postoperative analgesia (APA)
干预措施: Additional postoperative analgesia (Drug)
Local infiltration
local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA)
干预措施: Local infiltration (Procedure)
Local infiltration
local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA)
干预措施: TAVI (Procedure)
Local infiltration
local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA)
干预措施: Additional intraoperative analgesia (Drug)
Local infiltration
local anaesthesia infiltration performed by the operator for TAVI insertion with eventual intraoperative additional analgesia (AIA) and/or postoperative analgesia (APA)
干预措施: Additional postoperative analgesia (Drug)
结局指标
主要结局
Numeric Rating Scale (NRS)
时间窗: 24 hours
The numeric rating scale will be used to determine the intraoperative and postoperative pain intensity levels of the patients. Pain intensity is scored 0-10 (0=no pain, 10=the worst pain imaginable). The pain intensity will be measured at 5 time points intraoperatively (femoral artery cannulation, aortic valve system introduction, aortic valve system removal, vessel closure devices insertion and the end of the operation) and at 2 time intervals postoperatively (0-12 hours and 12-24 hours).
次要结局
- Additional intraoperative analgesia consumption(24 hours)
- Additional postoperative analgesia consumption(24 hours)
- Patient satisfaction with analgesia(3 days)
- Intraoperative and postoperative cost calculations(1 year)
研究者
Liudmila Hasak, MD, PhD
Principal Investigator
Medical University of Gdansk