Post-operative Analgesic Effect of Oral Nefopam
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral nefopam, Placebo.
- Who it may be relevant to
- Registry conditions: Postoperative Pain After a Total Knee Arthroplasty. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Postoperative Analgesic Effect of Orally Administrated Nefopam After a Total Knee Arthroplasty: a Randomized Controlled Trial
Overview
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).
Interventions
- Drug 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. - Drug 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
Primary outcome measures
- Total morphine consumption within 24h after the surgery. [Time frame: 24 hours after the surgery.]
Secondary outcome measures (12)
- Hyperalgesia - Pressure Pain Threshold [Time frame: 24 hours after the surgery]
- Hyperalgesia - Punctate Pain Intensity [Time frame: 24 hours after the surgery]
- Hyperalgesia - Allodynia zone [Time frame: 24 hours after the surgery]
- Pain intensity [Time frame: 24 hours after the surgery and 3 months after the surgery]
- Self reported safety outcomes [Time frame: 24 hours after the surgery]
- Measures Safety outcomes [Time frame: 24 hours after the surgery]
- Pharmacokinetics:Plasmatic and cerebrospinal fluid concentration of nefopam [Time frame: 2 hours after the first oral administration of nefopam or Placebo.]
- Pharmacokinetics:Plasmatic and cerebrospinal fluid concentration of nefopam-beta-D-glucuronide [Time frame: 2 hours after the first oral administration of nefopam or Placebo.]
- Pharmacokinetics:Plasmatic and cerebrospinal fluid concentration of nefopam-N-oxyde [Time frame: 2 hours after the first oral administration of nefopam or Placebo.]
- Pharmacokinetics:Plasmatic and cerebrospinal fluid concentration of nefopam-N-demethyl [Time frame: 2 hours after the first oral administration of nefopam or Placebo.]
- Pharmacokinetics:Plasmatic and cerebrospinal fluid concentration of Nefopam hydrochloride [Time frame: 2 hours after the first oral administration of nefopam or Placebo.]
- Persistent postoperative pain - DN4 (or DN2 by phone) [Time frame: 3 months after the surgery]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Département d'Anesthésie Réanimation, Groupement Hospitalier Nord, Hospices Civils de Lyon — Lyon
Identifiers
NCT: NCT04576078 · 69HCL20_0111 · 2020-002955-40