跳至主要内容
临床试验/NCT06336460
NCT06336460尚未招募不适用

Pericapsular Nerve Group (PENG) Block vs. the Fascia Iliaca Compartment (FIC) Block for Patients With Isolated Hip Fractures in the Emergency Department

Orange Park Medical Center0 个研究点目标入组 60 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Numeric pain score at 30 minutes

研究概览

简要总结

This study is a prospective, randomized clinical trial assessing the efficacy of physician-performed ultrasound-guided pericapsular nerve group (PENG) block vs fascia iliaca compartment (FIC) block for pain control in acute hip fracture.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The research associate/outcome assessor will not have access to group assignment and will therefore be blinded to the type of block. Although the patient, their caregiver(s), and the clinician caring for the patient will not be directly informed of the group assignment, a note will be logged in the clinical record by the physician placing the block indicating the details of the block after this procedure has been completed.

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

  • Adult (>= 18 years of age)
  • Isolated proximal hip fracture (defined as Intertrochanteric or more proximal) as identified by X-ray, Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) scan
  • Glasgow Coma Score (GCS) = 15
  • Subjective pain score of >= 5 on a scale of 0 to 10 just prior to the nerve block placement

排除标准

  • Patients who are unable to give consent due to altered mental status or dementia
  • Clinically intoxicated patients
  • Patients who are unable to communicate their numeric level of pain
  • Open fracture or penetrating hip trauma
  • Signs of infection or laceration at injection site
  • Patients with multi-system trauma
  • Painful distracting injury (injury causing significant pain that distracts the patient from having reliable scoring of hip fracture pain, e.g. humerus fracture, dislocated joint)
  • Requiring immediate surgical intervention (< 1 hour)
  • Deemed clinically unstable by treating physician
  • Abnormal vital signs (Pulse>120bpm, Systolic blood pressure < 100 mm Hg, Pulse O2 < 95%)
  • Patients on long-acting systemic opioid analgesia
  • Allergy to amide local anesthetics
  • Vulnerable populations including pregnant patients, prisoners, children, elderly dementia patients. All precautions will be taken to avoid coercion, harm and exploitation of these vulnerable populations, thus they are to be excluded from this study. They will receive pain medications as deemed appropriate by their treating physician.

结局指标

主要结局

Numeric pain score at 30 minutes

时间窗: 30 minutes after block placement

Numeric pain score at 60 minutes

时间窗: 1 hour after block placement

次要结局

  • Cumulative Morphine Milligram Equivalents in 24 hours after enrollment(24 hours after enrollment)

研究者

申办方类型
Other
责任方
Sponsor

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