Postoperative Analgesic Effect of Orally Administrated Nefopam After a Total Knee Arthroplasty: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Total morphine consumption within 24h after the surgery.
研究概览
简要总结
Primary knee arthroplasty by total prosthesis is a painful surgery, performed on patients with advanced gonarthrosis (stage III), thus already presenting hyperalgesia and hyperalgesia and allodynia. This terrain makes the risk of postoperative hyperalgesia but also of persistent postoperative risk of persistent post-surgical pain.
Nefopam is a non-opioid centrally acting analgesic drug used as a part of multimodal analgesia. The opioid-sparing effect of nefopam is still controversial across various surgical procedures. In France nefopam is only available as a parenteral formulation; however it is often administered orally. There is currently no study addressing the efficacy of oral nefopam for the postoperative pain management including pain prevention.
The investigators conduct a prospective, double-blinded randomized controlled study with the main objective to examine the effect of perioperative orally administered nefopam on postoperative pain after a total knee arthroplasty. Secondary objectives include the quantification of wound allodynia, analysis of adverse events, clinical outcomes, and a pharmacokinetic study of orally given nefopam (plasma and cerebrospinal fluid dosage).
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Nefopam has a distinct bitter taste. A taste masking compound non interfering with chemical properties of the drug is used in both arms. Orally given mixture (nefopam or placebo) is prepared by an independent nurse in a separate location and given to a patient in patient's ward.
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
- 否
入选标准
- •adult patients scheduled for a total knee arthroplasty under spinal anesthesia at the Hopital de la Croix Rousse, Hospice Civils de Lyon, France.
- •ASA (American Society of Anesthesiology) class between 1 et
- •written informed consent
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
研究组 & 干预措施
Placebo
Oral administration of a placebo 2 hours before the surgery following by one administration each 8h for 24h.
干预措施: Placebo (Drug)
NEFOPAM 60mg PO/ 8 hours
Oral administration of nefopam 60mg 2 hours before the surgery following by 60mg each 8h for 24h.
干预措施: Oral nefopam (Drug)
结局指标
主要结局
Total morphine consumption within 24h after the surgery.
时间窗: 24 hours after the surgery.
Total dose of morphine consumed in 24h frame by a patient (PCA and/or additional morphine administration - parenteral or oral)
次要结局
- Hyperalgesia - Pressure Pain Threshold(24 hours after the surgery)
- Persistent postoperative pain - DN4 (or DN2 by phone)(3 months after the surgery)
- Measures Safety outcomes(24 hours after the surgery)
- Pharmacokinetics:Plasmatic and cerebrospinal fluid concentration of nefopam-beta-D-glucuronide(2 hours after the first oral administration of nefopam or Placebo.)
- Hyperalgesia - Punctate Pain Intensity(24 hours after the surgery)
- Pain intensity(24 hours after the surgery and 3 months after the surgery)
- Self reported safety outcomes(24 hours after the surgery)
- Pharmacokinetics:Plasmatic and cerebrospinal fluid concentration of nefopam(2 hours after the first oral administration of nefopam or Placebo.)
- Hyperalgesia - Allodynia zone(24 hours after the surgery)
- Pharmacokinetics:Plasmatic and cerebrospinal fluid concentration of nefopam-N-demethyl(2 hours after the first oral administration of nefopam or Placebo.)
- Pharmacokinetics:Plasmatic and cerebrospinal fluid concentration of Nefopam hydrochloride(2 hours after the first oral administration of nefopam or Placebo.)
- Pharmacokinetics:Plasmatic and cerebrospinal fluid concentration of nefopam-N-oxyde(2 hours after the first oral administration of nefopam or Placebo.)
- Persistent postoperative pain - DN4(4 months after the surgery)