跳至主要内容
临床试验/NCT04945668
NCT04945668Unknown不适用

Combined Ultrasound and Fluoroscopy-guided Technique for Treatment of Hip Pain. A Pilot Study for a Suggested Approach for Anterior Hip Denervation

Mansoura University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
16
试验地点
2
主要终点
The success rate to target a suggested optimal landmark

研究概览

简要总结

Hip fracture is a challenging geriatric problem for health care professionals, especially in patients with multiple comorbidities. In patients with inoperable hip fractures secondary to severe comorbid conditions, the pain can lead to significant challenges in nursing care.

A recent anatomical study confirmed the innervation of the anterior hip by these 3 main nerves but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported.

详细描述

The aim of this study is to help to target a suggested optimum landmark and determine the volume of injectate that can cover the distribution of the anterior articular branches supplying the hip joint.

The anterior hip capsule is innervated by the ON, accessory obturator nerve (AON), and FN as reported by previous anatomic studies. The anterior capsule is the most richly innervated section of the joint.

Ultrasound-guided technique for blockade of these articular branches to the hip, the PENG (Pericapsular Nerve Group) block reported significantly reduced pain scores compared with baseline.

With the current understanding of the complex innervations of the hip joint, it is difficult to provide complete effective radiofrequency ablation to the articular branches supplying the hip joint. Chemical hip denervation using ultrasound was reported by previous case reports or series without mentioning a well-defined target point or an optimum injectate volume.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status I, II, and III.
  • Patients scheduled for elective or emergent hip fractures.

排除标准

  • Patient refusal.
  • Neuromuscular diseases (as myopathies, myasthenia gravies...)
  • Hematological diseases, bleeding, or coagulation abnormality.
  • Psychiatric diseases.
  • Local skin infection and sepsis at the site of the block.
  • Known intolerance to the study drugs.
  • Body Mass Index > 40 Kg/m
  • Multiple trauma patients.

结局指标

主要结局

The success rate to target a suggested optimal landmark

时间窗: just after skin puncture

Is defined as the percentage of success to reach the target point for injection with needle punctures to up to 4 skin punctures.

次要结局

  • Success rate of first skin puncture(just after skin puncture)
  • The optimum volume of the injectate(30 minutes before surgery.)
  • Pain measurement at rest(Prior to performing of nerve block, 15, 30 minutes after block performance)
  • Pain measurement on movement (attempted hip flexion to 15 degrees):(Prior to performing of nerve block, 15, 30 minutes after block performance)
  • Incidence of block failed block(30 minutes after Local Anesthetic injection)
  • The number of skin punctures:(just after skin puncture for the block)
  • the total number of needle passes required for obtaining the target landmark(just after skin puncture)
  • Time for first analgesic request(Within 24 hours after surgery)
  • Patient satisfaction score(Within 24 hours after the nerve block)
  • Complications:(Within 24 hours after the nerve block)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验