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临床试验/NCT06675916
NCT06675916已完成不适用

Assessment of PENG Block Analgesia Versus Intra-articular Infiltration in Hip Prosthesis Surgery

GCS Ramsay Santé pour l'Enseignement et la Recherche2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

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
2
主要终点
Morphine dose

研究概览

简要总结

After hip arthroplasty, pain intensity is maximum within the first 6 hours and is then estimated to last between 36 and 72 hours.

Pain management (analgesia) after hip prosthetic surgery remains a challenge. A bad analgesic treatment can result in delay in mobilization/ambulation and thus increase duration of patient's stay which can have a significant economic impact.

The different recognized analgesia techniques (intra-articular infiltration and peripheral nerve blocks) are effective but have shown certain limits.

A new peripheral nerve block, the PENG block has shown very encouraging results on postoperative analgesia quality.

In this context, this research is based on the hypothesis that ultrasound-guided PENG block could provide more effective analgesia than intra-articular infiltration during mini-invasive anterior hip prosthesis surgery.

详细描述

Each year, around140 000 patients undergo total hip arthroplasty. After hip arthroplasty, pain intensity is maximum within the first 6 hours and is then estimated to last between 36 and 72 hours. However, more and more patients want to no longer suffer after surgery. Indeed, if postoperative pain is moderate at rest, it is often exacerbated by movement. Severe pain occurs in 50 % of patients at rest and in 70% of patients during mobilization.

Pain management (analgesia) after hip prosthetic surgery remains a challenge for the anesthesiologist. A bad analgesic treatment can result in delay in mobilization/ambulation and thus increase duration of patient's stay which can have a significant economic impact. Quality analgesia is therefore essential to reduce post-operative pain and improve functional rehabilitation in patients undergoing hip surgery.

The different recognized analgesia techniques (intra-articular infiltration and peripheral nerve blocks) are effective but have shown certain limits: rapid and non-lasting effect of analgesia or poor targeting of all nerves of hip joint.

A new peripheral nerve block, the PENG block, identified during a recent anatomical study in 2018, has shown very encouraging results on postoperative analgesia quality on several small series of patients.

In this context, this research is based on the hypothesis that ultrasound-guided PENG block could provide more effective analgesia than intra-articular infiltration and therefore reduce the intraoperative opioid consumption during mini-invasive anterior hip prosthesis surgery under general anaesthesia.

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
None

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

  • Patient, male or female, over 18 years old.
  • Patient scheduled for hip prosthesis placement via the anterior approach

排除标准

  • Patient with local anesthesia contraindication.
  • Patient with a high level of dependency, defined by level 1 or 2 of Iso Ressources Group (GIR).

研究组 & 干预措施

PENG block

Experimental

Total hip prosthesis with infiltration of lidocaine hydrochloride by ultrasound-guided PENG block

干预措施: PENG Block with lidocaine hydrochloride (Procedure)

Intra-articular infiltration

Active Comparator

Total hip prosthesis with intra-articular infiltration of lidocaine hydrochloride

干预措施: Intra-articular infiltration with lidocaine hydrochloride (Procedure)

结局指标

主要结局

Morphine dose

时间窗: 1 day

Primary outcome measure is the total morphine quantity administered intraoperatively, in milligrams

次要结局

  • Patient quality of life(Day 1, 7 and 45)
  • Pain level(Day 0, 1, 7 and 45)
  • Hip symptoms and limitations(Day 45)
  • Hip impact on daily life(Day 45)

研究者

发起方
GCS Ramsay Santé pour l'Enseignement et la Recherche
申办方类型
Other
责任方
Sponsor

研究点 (2)

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