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临床试验/NCT04692428
NCT04692428已完成不适用

Fracture of the Upper Femoral Extremity in the Elderly Patients: Comparison of the Supra-inguinal Fascia Iliaca Block VS Femoral Nerve Block Ultrasound Guided in the Positioning and Post-operative Analgesia for Spinal Anesthesia

University Tunis El Manar2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Positioning pain before performing spinal anesthesia

研究概览

简要总结

Patients were randomly assigned to tow groups: infrainguinal ultrasound guided iliaca fascia block (FIBSI) and femoral nerve block (FNB) for FIBSI, the probe is placed transversely between anterior superior iliac spine (ASIS) and the pubic spine. The transducer is translated laterally to identify the Sartorius muscle. Cephalic inclination of the probe. The medial end of the transducer faces towards the umbilicus, which is the final position. The 100mm neurostimulation needle is advanced in the In Plan approach to pass through the iliac fascia. Once the correct position is confirmed, 30 ml of 1% Ropivacaine is gradually injected between the iliac fascia and the iliac muscle.

For FNB, the probe was placed under the inguinal ligament. The femoral vessels and the nerve section are visualized; The 100mm neurostimulation needle is advanced in the In Plan approach and 30ml of 1% Ropivacaine has been injected along the nerve sheath

详细描述

Patients were randomly assigned to tow groups: infrainguinal ultrasound guided iliaca fascia block (FIBSI) and femoral nerve block (FNB) for FIBSI,the probe is placed transversely between the EIAS and the pubic spine,The transducer is translated laterally to identify the sartorius muscle. Cephalic inclination of the probe: The iliac muscle is located at the medial border in the shadow of the superior anterior iliac spine.The medial end of the transducer faces towards the umbilicus, which is the final position.

The anatomy identified, from superficial to deep, consisting of subcutaneous fat, internal oblique muscle, transverse abdominal muscle, iliaca fascia covering the iliac muscle. The 100mm neurostimulation needle is advanced in In Plan approach to cross the iliaca fascia. With the tip of the needle just below the iliaca fascia, 2 ml of local anesthetic was injected to confirm the location of the tip. Once the correct position is confirmed, 30 ml of 1% Ropivacaine is gradually injected between the iliac fascia and the iliac muscle.

for FNB,The probe was placed under the inguinal ligament. Femoral vessels and sectional nerve are visualized. The nerve was located, an 100mm neurostimulation needle is advanced in In Plan approach, and 30 ml of 1% Ropivacaine was injected along the nerve sheath.

研究设计

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

入排标准

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

入选标准

  • ASA (American Society of Anesthesiologists) class I, II, and III patients scheduled for emergency surgery with the diagnosis of proximal femur fracture

排除标准

  • hemorrhagic diathesis,
  • peripheral neuropathies,
  • allergy to amide local anaesthetics,
  • mental disorders,
  • those on analgesics within 8 hour prior to performing nerve block

结局指标

主要结局

Positioning pain before performing spinal anesthesia

时间窗: 20 minutes after realization of blocks

Pain in positioning was assessed by measuring the simple verbal scale (0= no pain- 4= worst pain possible) after 20 minutes for realization block

次要结局

  • Postoperative pain(at the third, sixth, twelfth and twenty-four hours postoperatively)
  • quality of patient placement in the sitting position(after 20 minutes of realization of block)
  • The level of sensory block at 20 minutes after realization of block(before and 20 minutes after realization of blocks)
  • Patient satisfaction(five minutes after the end of the realization of spinal anesthesia)

研究者

发起方
University Tunis El Manar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mechaal Benali

Professor

University Tunis El Manar

研究点 (2)

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