Analgesic Effect of Illiohypogastic & Ilioinguinal Nerve Block in TAVR - TF (Prospective Randomized Study)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Extra Demand of sedation
研究概览
简要总结
The purpose of the study is to compare the effect of illiohypogastric and ilioinguinal nerve block with the local infiltration with lidocaine in patients undergoing TAVI
详细描述
This prospective, randomized, double blinded study will take place at cardiothoracic academy, Ain Shams University hospitals, Cairo, Egypt. In this study, participants, care providers and outcomes assessors will be ignorant of the treatment allocation. The study will start after obtaining the ethical approval & will continue for a 1 year. All patients will sign written informed consent before inclusion.
Patients fulfilling criteria for TAVI regarding age & pathology of aortic valve will be included in the study.
Exclusion criteria:
Refusal of the patients, Patients with neurological disease (Disturbed conscious level or psychiatric illness) severe respiratory disease need mechanical ventilation or need respiratory support, coagulation abnormalities, infection at site of injection.
After confirming the diagnosis & preoperative sizing of the valve by CT heart and then confirmation that no need for TEE guidance of the procedure, we will include 60 patients and then will be divided into two groups according to the technique of local anesthesia for the site of puncture.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
- Group (A): will receive blind local infiltration in femoral region on the operation side by an experienced anesthesiologist using 20 ml lidocaine 1% (9).
- Group (B): will receive ultrasound-guided ilioinguinal/iliohypogastric nerve block using 20 ml Bupivicane 0.25% by an experienced anesthesiologist.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fulfilling criteria for TAVI regarding age & pathology of aortic valve will be included in the study.
排除标准
- •Refusal of the patients, Patients with neurological disease (Disturbed conscious level or psychiatric illness) severe respiratory disease need mechanical ventilation or need respiratory support, coagulation abnormalities, infection at site of injection.
研究组 & 干预措施
Group A:Lidocaine group
will receive blind local infiltration in femoral region on the operation side by an experienced anesthesiologist using 20 ml lidocaine 1%
干预措施: Lidocaine (Drug)
Group B:Bupivacaine group
will receive ultrasound-guided ilioinguinal/iliohypogastric nerve block using 20 ml Bupivicane 0.25% by an experienced anesthesiologist
干预措施: Bupivacain (Drug)
结局指标
主要结局
Extra Demand of sedation
时间窗: All through procedure
Need for increments of narcotics or propofol will be recorded and collected at the end of the procedure.
次要结局
- Patient and surgeon satisfaction(all through the procedure)
研究者
maha sadek El Derh
Assistant professor of Anesthesia
Ain Shams University