2024-513796-40-00招募中4 期
Postoperative analgesic effect of orally administrated nefopam after a total knee arthroplasty: a randomized controlled trial (NefPO)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Total morphine consumption within 24h after the surgery.
研究概览
简要总结
The primary objective of this study is to measure whether orally administered nefopam significantly reduces morphine consumption at 24h after total knee replacement (TKR) surgery in adults compared with placebo.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient over
- •Patient scheduled for primary PTG under spinal anesthesia, in the orthopedics department of the Croix-Rousse hospital.
- •Patient with an American Society of Anesthesiology (ASA) score between I and III.
- •Patient having agreed to take part in the study and having signed the informed consent form.
- •Patient entitled to social security benefits.
- •Patient willing to return for all study visits.
排除标准
- •Any contraindication for nefopam (known hypersensitivity, past medical history of seizures, urinary retention, benign prostate hyperplasia, angle glaucoma, ischemic cardiomyopathy waiting for revascularization, atrial fibrillation)
- •Medical conditions known to influence the pharmacokinetics of nefopam (chronic kidney failure with Glomerular Filtration Rate (GFR) <30mL/min/1,73m2, liver failure, current treatment with rifampicin, carbamazepine, azoles fungicides, macrolides)
- •Current treatment with benzodiazepines, anxiolytics, antidepressants, histamine H1 antagonists, neuroleptics, baclofen, thalidomide, barbiturates
- •Medical history of gastric or esophageal surgery.
- •Phenylketonuria
- •Pregnancy or breastfeeding
- •Past use of oral nefopam
结局指标
主要结局
Total morphine consumption within 24h after the surgery.
Total morphine consumption within 24h after the surgery.
次要结局
- Persistent postoperative pain - DN4
- Persistent postoperative pain - DN4 (or DN2 by phone)
- Plasmatic and cerebrospinal fluid concentration of Nefopam hydrochloride
- Pressure Pain Threshold
- Punctate Pain Intensity
- Allodynia zone
- Pain intensity
- Self reported safety outcomes
- Measures of safety outcomes
- Plasmatic and cerebrospinal fluid concentration of nefopam
- Plasmatic and cerebrospinal fluid concentration of nefopam-beta-D-glucuronide
- Plasmatic and cerebrospinal fluid concentration of nefopam-N-oxyde
- Plasmatic and cerebrospinal fluid concentration of nefopam-N-demethyl
研究者
Pr AUBRUN
Scientific
Hospices Civils De Lyon
研究点 (1)
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