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临床试验/NCT03798834
NCT03798834已完成不适用

Fascia Iliaca Block as an Anesthetic Technique for Thromboembolectomy of Chronic Lower Limb Ischemia

Mansoura University1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2018年11月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
1
主要终点
The proportion of the patients who did not require conversion to general anesthesia

研究概览

简要总结

The fascia iliaca block (FIB) is an anterior approach to block the lumbar plexus. It disturbed mainly to the anterior region of the thigh by blocking the femoral nerve (LFC) and the lateral femoral cutaneous nerve. Moreover, FIB may possibly be extended to the obturator, ilioinguinal, genitofemoral, lateral cutaneous nerve of the thigh and over the psoas muscle but, rarely reaches the lumbar plexus.

The fascia iliaca compartment could be detected by bony landmarks palpation and the loss of resistance technique. Feeling two tactile ''pops'' due to loss of resistance occurred during the needle passage through the fascia lata and the fascia iliaca. Ultrasound (US) guidance of FIB will increase the success rate and the efficacy of sensory blockade by decreasing the needed local anesthetic amount.

详细描述

This study was conducted to demonstrate the success incidence (to evaluate the efficacy) of preoperative 0.25% bupivacaine FIB as a sole anesthetic technique in thromboembolectomy of unilateral chronic lower limb ischemia compared to neuraxial anesthesiaas a primary goal. Intraoperative hemodynamics variation, postoperative pain score, total analgesic rescue requests and the total amount of systemic rescue analgesia used in the first postoperative day in addition to any detected postoperative complications were secondary goals. The hypothesis is that; FIB will provide adequate anesthesia as neuraxial anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status I or II.

排除标准

  • Patients with previous same lower limb surgery
  • Neuromuscular disease
  • Severe cardiovascular disease
  • Any contraindications to regional anesthesia
  • patient refusal
  • coagulation abnormality
  • Known allergy to local anesthetics
  • Infection at the injection site

研究组 & 干预措施

Fascia iliaca block (FIB)

Experimental

ultrasound-guided Fascia iliaca block

干预措施: Fascia iliaca block (FIB) (Drug)

Spinal anesthesia

Placebo Comparator

Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%

干预措施: Spinal anesthesia (Other)

结局指标

主要结局

The proportion of the patients who did not require conversion to general anesthesia

时间窗: for 30 minutes

次要结局

  • bradycardia(For 24 hours from the block)
  • Postoperative pain(For 24 hours after the intervention)
  • Heart rate(For 6 hours after the intervention)
  • mean arterial pressure (MAP(For 6 hours after the intervention)
  • hypotension(For 24 hours from the block)
  • Any observed adverse effects(over the 24 hours postoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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