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临床试验/NCT04555291
NCT04555291已完成不适用

Analgesic Efficiency of the Type 3 Quadratum Lumborum Block in Patients Undergoing Total Hip Arthroplasty : a Randomized Double Blinded Trial

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月5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
入组人数
60
试验地点
2
主要终点
Opoïd consumption

研究概览

简要总结

Total hip arthroplasty (THA) is one of the main elective orthopedic surgery. Recent studies have proven that patients undergoing an elective THA who are part of a fast track surgery program including an opioid free anesthesia (OFA) presented a decrease of mortality and a reduced in-hospital length of stay. Based on the anatomical knowledges, the Quadratus Lumborum Block seems to be an interesting locoregional technique for patients undergoing THA. So far, there is no recommanded locoregional aesthesia in this indication. The investigators hypothezised that QLB would give an efficient analgesia in the 24h following a THA.

Therefor, the study performed a prospective, randomized, double blind trial in the Nice Universitary hospital of Pasteur 2 and in Arnault Tzanck Institute among all patients who underwent THA, comparing a QLB using ropivacaïne 2mg/ml 20ml vs isotonic saline solution 20 ml.The main end-point is the decrease opiod consumption in the 24h following THA.

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, Investigator)

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

  • All adult patients with unilateral programmed total hip prosthesis surgery are included in the absence of inclusion criteria.
  • Obligation for all patients to be affiliated with social security
  • Patient Informed Consent Signature

排除标准

  • chronic opiod consumption
  • pregnancy
  • mental disorder that prevents the usage of the numeric analog scale
  • Contra indications of the realization of QLB
  • Local infection
  • Allergic to the local anesthesia
  • Hemostasis disorder
  • Incapacity of giving the consent : individuals under guardianship by court order, or under judicial protection

研究组 & 干预措施

Drug Ropivacaïne 2 mg/ml

Experimental

Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of ropivacaïne 2 mg/ml

干预措施: Ropivacaine injection (Drug)

NACL

Placebo Comparator

Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of NACL

干预措施: NACL (Other)

结局指标

主要结局

Opoïd consumption

时间窗: At 24 Hours

The main end point of this study is the decrease of opiod consumption in the 24h following THA.

次要结局

  • morphine equivalent dose(At 48 Hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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