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Post-operative Analgesic Effect of Oral Nefopam

Study acronym: NefPO
StatusRecruiting
PhasePhase 2
Started2021-06-29
View on ClinicalTrials.gov ↗

Amendment history

2026-05-13
minor
Study Status, Study Design, Contacts/Locations v4
Primary completion date2026-06-30→2026-12-30
Completion date2026-11-15→2027-05-15
Enrollment target40→50
Study sitesdetails revised at 1 of 1 site
2024-04-19
minor
Study Status v3
Primary completion date2024-06-30→2026-06-30
Completion date2024-11-15→2026-11-15
2023-04-11
minor
Study Identification, Study Status, Study Description, Conditions, Study Design, Outcome Measures, Eligibility v2
Primary completion date2023-07-30→2024-06-30
Completion date2023-11-15→2024-11-15
Enrollment target58→40
Eligibility criteria+2 characters
Inclusion Criteria: adult patients scheduled for a hightotal tibialknee osteotomyarthroplasty under spinal anesthesia at the Hopital de la Croix Rousse, [...]
Secondary endpoints12 to 13 entries
Persistent postoperative pain - DN4 (or DN2 by phone)
2022-01-17
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2022-10→2023-07-30
Completion date2023-02→2023-11-15
Start dateestimated 2020-10→confirmed 2021-06-29
Study sites0→1
Study title-31 characters
Post-operative Analgesic Effect of Oral Nefopam: a Randomized Controlled Trial
2020-09-29
minor
Original filing
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).
Trial Details
NCT Number NCT04576078
Lead Sponsor Hospices Civils de Lyon
Conditions Postoperative Pain After a Total Knee Arthroplasty
Enrollment 50 participants
Start Date 2021-06-29
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-05-15 (estimated)
Updated on ClinicalTrials.gov 2026-05-14