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临床试验/NCT04335461
NCT04335461撤回早期 1 期

Postoperative Pain Control in Extracapsular Hip Fracture Patients: Fascia Iliaca Compartment Block Versus Fracture Block

Montefiore Medical Center1 个研究点 分布在 1 个国家开始时间: 2021年8月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
撤回
试验地点
1
主要终点
Pain visual analog scores

研究概览

简要总结

The investigators propose to investigate the effect of intraoperative FICB and intrafragmentary fracture blockade on postoperative pain and opiate consumption using a randomized controlled trial study design. There will be three treatment groups: (1) fascia iliaca compartment blockade administered after surgical fixation using the loss of resistance technique with 30cc 0.25% marcaine (2) intrafragmentary fracture block using fluoroscopy guidance after surgical fixation with 30cc 0.25% marcaine and (3) placebo group, with no intervention.

详细描述

The incidence of fragility hip fractures in elderly patients is increasing steadily in the United States and worldwide, and the mortality, morbidity and economic impact of this injury is staggering. The injury itself can result in severe pain, both preoperatively and throughout the perioperative course. These patients are also at increased risk for delirium. They are by definition elderly, and often have multiple comorbidities in addition to underlying cognitive dysfunction. Current studies estimate that the incidence of delirium after a hip fracture approaches 30%, and there is a well-established though not completely understood interaction between opioid use in elderly patients and delirium. Pain and delirium are not only poor outcomes in themselves, but they can also interfere with the rehabilitation necessary for a successful outcome after hip fracture surgery. For this reason, the topic of multimodal pain management in hip fracture patients has gained considerable traction.

One popular "opioid-sparing" strategy in these patients is regional pain blockades, administered by an anesthesia block team or by emergency room physicians. Due to the neuroanatomy of the hip region, which has sensory innervations from the sciatic, femoral, and obturator nerve, with lesser contributions from the nerve to quadratus femoris and superior gluteal nerve, effective regional blockade of the hip joint with existing methods can be a challenge. One commonly employed and researched block is the fascia iliaca compartment block (FICB), a regional block administered under ultrasound guidance or anatomical landmarks that targets the femoral nerve, the lateral femoral cutaneous nerve, and to a lesser extent, the obturator nerve. Various studies of FICB and the closely related femoral nerve block have demonstrated benefits in pain control, ease of positioning, and reduction in opiate use, and systematic reviews have concluded that the fascia iliaca compartment block is a useful and safe method to enhance preoperative pain control in hip fracture patients. However, prior research has focused on the preoperative period, with blocks placed by an anesthesia team or emergency room physicians shortly after presentation and diagnosis of a hip fracture. Additionally, no distinction is made between intracapsular or extracapsular hip fractures, except in scattered post-hoc analyses. Our project aims to investigate the efficacy of a FICB administered intraoperatively by the operating surgeon on extracapsular hip fracture patients. In addition, the investigators propose investigating intrafragmentary blockade at the fracture site itself. Fracture hematoma blocks are used extensively in orthopedics, and have demonstrated pain control equivalent to conscious sedation for the manipulation of ankle and distal radius fractures.

Study Design

The investigators propose to investigate the effect of intraoperative FICB and intrafragmentary fracture blockade on postoperative pain and opiate consumption using a randomized controlled trial study design. There will be three treatment groups: (1) fascia iliaca compartment blockade administered after surgical fixation using the loss of resistance technique with 30cc 0.25% marcaine (2) intrafragmentary fracture block using fluoroscopy guidance after surgical fixation with 30cc 0.25% marcaine and (3) placebo group, with no intervention

Randomization will occur at time of enrollment using unmarked envelopes. After consent, patients will be assigned a study ID that will be transcribed on the opaque envelope. The envelope will be unsealed in the operating room at time of surgery to determine the planned intervention, and it's contents will not be made available to the study personnel gathering postoperative pain data. The envelopes and randomization assignments will be kept in a locked, secured location. The only study personnel who will be unblinded are the operating surgeon and residents and physican assistants assisting in the operating room. Study personnel who participate in the case will not collect postoperative pain data.

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
Double (Participant, Outcomes Assessor)

盲法说明

Randomization will occur at time of enrollment using unmarked envelopes. After consent, patients will be assigned a study ID that will be transcribed on the opaque envelope. The envelope will be unsealed in the operating room at time of surgery to determine the planned intervention, and it's contents will not be made available to the study personnel gathering postoperative pain data. The envelopes and randomization assignments will be kept in a locked, secured location. The only study personnel who will be unblinded are the operating surgeon and residents and physican assistants assisting in the operating room.

入排标准

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

入选标准

  • age 60 years or older
  • low energy mechanism (i.e. mechanical or syncopal fall from ground level)
  • extracapsular location as defined on AP and lateral radiographs of the hip

排除标准

  • polytrauma patients with multiple injuries, high energy mechanisms (i.e. pedestrian struck, motor vehicle collision, fall from height)
  • inability for the patient to consent for themselves
  • pathologic fracture types (secondary to tumor or atypical fractures due to bisphosphonate use)
  • intolerance or allergies to opioids or local anesthetics

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo group, with no regional nerve blockade administered.

干预措施: Cephalomedullary nailing of extracapsular hip fracture (Procedure)

Placebo

Placebo Comparator

Placebo group, with no regional nerve blockade administered.

干预措施: cephalomedullary nail (Device)

Fracture block

Experimental

Patients will have an intrafragmentary fracture block using fluoroscopy guidance after surgical fixation with 30cc 0.25% marcaine

干预措施: Cephalomedullary nailing of extracapsular hip fracture (Procedure)

Fracture block

Experimental

Patients will have an intrafragmentary fracture block using fluoroscopy guidance after surgical fixation with 30cc 0.25% marcaine

干预措施: cephalomedullary nail (Device)

Fracture block

Experimental

Patients will have an intrafragmentary fracture block using fluoroscopy guidance after surgical fixation with 30cc 0.25% marcaine

干预措施: Regional Anesthetics (Drug)

Fascia iliaca block

Experimental

Fascia iliaca compartment blockade administered after surgical fixation using the loss of resistance technique with 30cc 0.25% marcaine

干预措施: Cephalomedullary nailing of extracapsular hip fracture (Procedure)

Fascia iliaca block

Experimental

Fascia iliaca compartment blockade administered after surgical fixation using the loss of resistance technique with 30cc 0.25% marcaine

干预措施: cephalomedullary nail (Device)

Fascia iliaca block

Experimental

Fascia iliaca compartment blockade administered after surgical fixation using the loss of resistance technique with 30cc 0.25% marcaine

干预措施: Regional Anesthetics (Drug)

结局指标

主要结局

Pain visual analog scores

时间窗: 24 hours

The pain visual analog scale will be used to record pain scores from 0 (no pain) to 10 (worst pain imaginable).

次要结局

  • Opioid usage(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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