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临床试验/NCT05256056
NCT05256056已完成不适用

Comparison of the Volume Dependent Effect of Pericapsular Nerve Block in Patients Operated for Femur Fracture: A Randomized Prospective Study

Sisli Hamidiye Etfal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
visual analouge scale

研究概览

简要总结

In PENG block technique, the local anesthetic agent is injected between the psoas tendon and the pubic ramus to block the sensory branches of the nerves which innervates the hip capsule for providing analgesia without causing muscle weakness. Since the PENG block is a facial plane block, it causes a volume dependent distribution. There are a few case reposts and cadaveric studies on volume dependent effect of analgesia and motor weakness of PENG block.

In our study, we aimed to evaluate the clinical effects of the volume-dependent efficacy of PENG block.

详细描述

Femur fracture is the one of the most common case groups and it is seen mostly in the elderly patient population with comorbidities. For these patients, perioperative, postoperative analgesia and early mobilization are important to reduce cardiopulmonary complications and morbidity. Femoral fracture operations are mostly performed under spinal anesthesia especially under unilateral spinal anesthesia to sustain more stable hemodynamics. The lateral decubitus position, which is used for unilateral spinal anesthesia, is a painful position for these patients. Intravenous opioids are used for this procedure, however they have possible side-effects, such as sedation, inhibition of respiratory, lower blood pressure. Because of these reasons, pericapsular nerve block (PENG) has been applied recently to avoid complications. By using PENG block , positioning for spinal anesthesia is easier for patients and anesthesiologists, and postoperative analgesia can be provided.

By PENG block, the local anesthetic agent is injected between the psoas tendon and the pubic ramus to block the sensory branches of the nerves innervating the hip capsule, thus providing analgesia in patients, but muscle weakness is not expected. Becacuse PENG block is a facial plane block, it shows a volume dependent distribution. There are a few case reposts and cadaveric studies, which are showing volume depend effect of analgesia and motor weakness of PENG block.

In our study, we aimed to evaluate the clinical effects of the volume-dependent efficacy of PENG block.

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

Patients will be randomized using the closed envelope method. While the practitioner knows the interventions to be made, the data collector will collect the data without learning the patient's group.

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

  • Patients who will undergoing hip arthroplasty surgery
  • Patients over the age of 18
  • ASA I-II-III patients
  • Patients who will be operated under spinal anesthesia

排除标准

  • ASA IV patients, Pregnant women
  • Patients who are not suitable for spinal anesthesia
  • Patients diagnosed with Alzheimer's and dementia who cannot cooperate
  • Patients who are not suitable for peripheral nerve block (patients with infection in the injection area, with local anesthetic allergy, with coagulopathy)
  • Patients who do not want to participate in the study
  • Patients under the age of 18
  • Patients switched to general anesthesia

研究组 & 干预措施

Group A

Experimental

patients will be injected with 20 cc of 0.25% Bupivacaine

干预措施: Bupivacain (Drug)

Group B

Experimental

patients will be injected with 30 cc of 0.25% Bupivacaine.

干预措施: Bupivacain (Drug)

结局指标

主要结局

visual analouge scale

时间窗: up to 24 hours,

the VAS 0 means no pain, 10 means the worst pain possible

pin-prick test

时间窗: up to 20 minutes

the ability to determine the difference between sharp and dull.

次要结局

  • cold sensation test(up to 20 minutes)
  • presence of quadriceps motor block(up to 24 hours)

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gamze Dilara Demir

specialist medical doctor

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (1)

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