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临床试验/NCT04690647
NCT04690647已完成不适用

The Efficacy of Ultrasound Guided Suprainguinal Fascia Iliaca Compartment Block for Acute Paint Control After Elective Total Hip Replacement Using Postero-lateral Approach

Saint Lucas Hospital, Poland1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年9月28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
150
试验地点
1
主要终点
Hospital stay [days]

研究概览

简要总结

Total hip replacement surgery is one of the most common orthopedic interventions. Proper anaesthesia and adequate analgesia is one of the key interests of attending anaesthetist. Recent studies show that ultrasound guided suprainguinal fascia iliaca compartment block may play a significant role in proper management of pain after these procedures. The aim of this study was to assess the clinical usefulness and compare different methods of anaesthesia for total hip replacement surgery via posterolateral approach.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-75 years old
  • informed consent to participate in the study
  • ASA score I-III
  • BMI -19-30kg/m2
  • qualified for total hip replacement
  • no contraindication to used anesthesia and drugs

排除标准

  • contraindications to spinal anesthesia and regional blocks
  • previously coexisting chronic pain
  • previously opioids intake
  • BMI>30kg/m2
  • allergy to drugs using during study
  • mental status preventing the usage of patient controlled analgesia pump

研究组 & 干预措施

Opioid and non opioid postoperative analgesia.

Placebo Comparator

Group of patients with opioid and non opioid based postoperative analgesia without preoperative regional anaesthesia and dexamethasone.

干预措施: Opioid and non opioid postoperative analgesia. (Other)

Regional anaesthesia, opioid and non opioid postoperative analgesia.

Experimental

Group of patients with opioid and non opioid based postoperative analgesia with preoperative regional anaesthesia and without preoperative dexamethasone.

干预措施: Opioid and non opioid postoperative analgesia. (Other)

Regional anaesthesia, opioid and non opioid postoperative analgesia.

Experimental

Group of patients with opioid and non opioid based postoperative analgesia with preoperative regional anaesthesia and without preoperative dexamethasone.

干预措施: Fascia iliaca compartment block (Other)

Regional anaesthesia, dexamethasone, opioid and non opioid postoperative analgesia

Experimental

Group of patients with opioid and non opioid based postoperative analgesia with preoperative regional anaesthesia and dexamethasone.

干预措施: Opioid and non opioid postoperative analgesia. (Other)

Regional anaesthesia, dexamethasone, opioid and non opioid postoperative analgesia

Experimental

Group of patients with opioid and non opioid based postoperative analgesia with preoperative regional anaesthesia and dexamethasone.

干预措施: Fascia iliaca compartment block (Other)

Regional anaesthesia, dexamethasone, opioid and non opioid postoperative analgesia

Experimental

Group of patients with opioid and non opioid based postoperative analgesia with preoperative regional anaesthesia and dexamethasone.

干预措施: Dexamethasone (Drug)

结局指标

主要结局

Hospital stay [days]

时间窗: 31 days

Total length of hospital stay was noted.

Opioid consumption [mg]

时间窗: 48 hours

Postoperative opioid consumption was noted.

Opioid related adverse effects

时间窗: 48 hours

Postoperative incidence of nausea, vomiting, constipation and apnea were noted.

次要结局

  • Likert scale(31 days)

研究者

发起方
Saint Lucas Hospital, Poland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wojciech Gola

MD, Head of The Department of Anesthesia

Saint Lucas Hospital, Poland

研究点 (1)

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