Post-operative Analgesic Effect of Oral Nefopam

Официальное название

Postoperative Analgesic Effect of Orally Administrated Nefopam After a Total Knee Arthroplasty: a Randomized Controlled Trial

Обзор

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).

Вмешательства

• Препарат Oral nefopam
  Oral administration of nefopam 60mg 2 hours before the surgery following by 60mg each 8h for 24h. Oral nefopam is prepared ex-tempore from the intravenous formulation adding a taste masking compound by a non-caring nurse following detailed instructions.
• Препарат Placebo
  Oral administration of a placebo 2 hours before the surgery following by one administration each 8h for 24h. Oral placebo is prepared ex-tempore with a taste masking compound by a non-charge nurse following detailed instructions

Первичные конечные точки

• Total morphine consumption within 24h after the surgery. [Срок оценки: 24 hours after the surgery.]

Вторичные конечные точки (12)

• Hyperalgesia - Pressure Pain Threshold [Срок оценки: 24 hours after the surgery]
• Hyperalgesia - Punctate Pain Intensity [Срок оценки: 24 hours after the surgery]
• Hyperalgesia - Allodynia zone [Срок оценки: 24 hours after the surgery]
• Pain intensity [Срок оценки: 24 hours after the surgery and 3 months after the surgery]
• Self reported safety outcomes [Срок оценки: 24 hours after the surgery]
• Measures Safety outcomes [Срок оценки: 24 hours after the surgery]
• Pharmacokinetics:Plasmatic and cerebrospinal fluid concentration of nefopam [Срок оценки: 2 hours after the first oral administration of nefopam or Placebo.]
• Pharmacokinetics:Plasmatic and cerebrospinal fluid concentration of nefopam-beta-D-glucuronide [Срок оценки: 2 hours after the first oral administration of nefopam or Placebo.]
• Pharmacokinetics:Plasmatic and cerebrospinal fluid concentration of nefopam-N-oxyde [Срок оценки: 2 hours after the first oral administration of nefopam or Placebo.]
• Pharmacokinetics:Plasmatic and cerebrospinal fluid concentration of nefopam-N-demethyl [Срок оценки: 2 hours after the first oral administration of nefopam or Placebo.]
• Pharmacokinetics:Plasmatic and cerebrospinal fluid concentration of Nefopam hydrochloride [Срок оценки: 2 hours after the first oral administration of nefopam or Placebo.]
• Persistent postoperative pain - DN4 (or DN2 by phone) [Срок оценки: 3 months after the surgery]

Критерии участия

Критерии включения

• 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 3.
• written informed consent

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Département d'Anesthésie Réanimation, Groupement Hospitalier Nord, Hospices Civils de Lyon — Lyon

Идентификаторы

NCT: NCT04576078 · 69HCL20_0111 · 2020-002955-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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