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临床试验/NCT04309539
NCT04309539Unknown不适用

- Efficacy of Combined Lateral Femoral Cutaneous Nerve Block With Pericapsular Nerve Group Block Versus Fascia Iliaca Block in Proximal Femoral Fractures

Mansoura University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Time of performance of Spinal Anesthesia

研究概览

简要总结

This patient population is typically elderly and frail. They are at risk of adverse effects secondary to inadequate pain management such as prolonged admissions and poor functional outcomes.

Regional analgesia is preferred due to their opioid-sparing effects and reduction in related adverse effects but The analgesia from these blocks is only moderate and literature suggests that the obturator nerve (ON) is not covered.

详细描述

The aim of this study is to compare the effect of combined lateral femoral cutaneous nerve block with pericapsular nerve group block versus fascia iliaca block for proximal femur surgery.

Fascia iliaca compartment block is a simple technique to manage pain before positioning for spinal anesthesia performance and it constitutes a practical choice for perioperative pain control.

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 The high articular branches from FN and AON are consistently found between the anterior inferior iliac spine (AIIS) and the iliopubic eminence (IPE), whereas the ON is located close to the inferomedial acetabulum.

The 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. Roy et al 2019 recommended the use of PENG block together with LFCN block as adjunctive to cover the lateral surgical incision.

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 (Outcomes Assessor)

盲法说明

Single-blind study

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

  • American Society of Anesthesiologists (ASA) physical status I, II and III.

排除标准

  • Patient refusal.
  • Neuromuscular diseases
  • Hematological diseases
  • Bleeding abnormality
  • Coagulation abnormality.
  • Psychiatric diseases.
  • Local skin infection at the site of the block.
  • Local skin 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

Time of performance of Spinal Anesthesia

时间窗: just before surgery.

Is defined as the time measured from the start of positioning to the completion of the intrathecal bupivacaine injection

次要结局

  • Pain measurement at rest(immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.)
  • Pain measurement on movement(immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.)
  • Duration of sensory block(postoperative 24 hours)
  • heart rate(pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery)
  • Mean arterial blood pressure(pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery)
  • Time to onset of Sensory blockade(evaluated 15 and 30 min after block administration)
  • Time to onset of motor block(evaluated 15 and 30 min after block administration)
  • Duration of motor block(postoperative 24 hours)
  • Pain measurement during positioning for spinal anesthesia(Just before surgery)
  • Pruritis(Within 24 hours after surgery)
  • vomiting(Within 24 hours after surgery)
  • The severity of postoperative pain at rest(immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.)
  • The severity of postoperative pain on movement(immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.)
  • Total analgesics received(for 24 hrs after surgery)
  • nausea(Within 24 hours after surgery)
  • Anesthesiology satisfaction for patient positioning(just before surgery)
  • Peripheral oxygen saturation(pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery)
  • Time for first analgesic request(Within 24 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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