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临床试验/NCT04295408
NCT04295408已完成不适用

Efficacy of Pericapsular Nerve Group Block After Total Hip Arthroplasty Surgery

University Tunis El Manar2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年4月30日最近更新:
适应症

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
Total morphine consumption

研究概览

简要总结

Controlling pain after hip replacement surgery improves comfort and partient satisfaction. Pain after hip replacement has traditionally been managed using systemic pain medications including acetaminophen and non-steroidal anti-inflammatory drugs. A recent Cochrane review demonstrated that compared to systemic analgesia alone, peripheral nerve blocks reduce postoperative pain with moderate-quality evidence. Pericapsular Nerve Group block is a new technique allowing local anesthetic diffusion to femoral, obturator and accessory obturator nerves and providing a good analgesic effect for hip fracture surgery. Investigators hypothesized that the PENG block could be an interesting alternative to systemic analgesiscs for pain control after total hip replacement.

详细描述

The aim of the study was to evaluate the efficacy of the PENG block for intra and postoperative pain control in total hip arthroplasty.

it was a monocentric, randomized, controlled and double blind study. Patients scheduled for primary THA with lateral approach under general anesthesia.

Premedication with IV midazolam 1 to 2 mg on arrival to operating theatre. general anesthesia was conducted using fentanyl, propofol and cisatracurium for induction and isoflurane for maintanance patients were randomized using a random table in two groups:

  • PENG Block group (PG) who received 2 mg.kg-1Ropivacaine in 40 ml of saline.
  • Placebo group (SG) who received 40 ml of saline.

Postoperative analgesia started before extubation of the patient, with:

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)

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

  • primary THA with lateral approach under general anesthesia.

排除标准

  • Hip fracture,
  • allergy to local anesthetics,
  • peripheral neuropathy,
  • creatinin clearance inferior to 30ml/min,
  • weight inferior to 50 Kg or superior to 100 Kg,
  • neurological disorder affecting the lower extremity, significant psychiatric conditions,
  • patients receiving corticosteroid therapy,
  • chronic consumption of opioids (>2 months).

结局指标

主要结局

Total morphine consumption

时间窗: day one

morphine consumption on mg

次要结局

  • Pain score after extubation(up to 30 minutes)
  • postoperative pain score(day one)
  • intraoperative opioid consumption(Day 0)
  • Pain score during seating position(day one)

研究者

发起方
University Tunis El Manar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olfa kaabachi, MD

Professor

University Tunis El Manar

研究点 (2)

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