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Postoperative analgesic effect of orally administrated nefopam after a total knee arthroplasty: a randomized controlled trial (NefPO)

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513796-40-00
Acronym
69HCL20_0111
Enrollment
46
Registered
2024-07-30
Start date
2021-06-29
Completion date
Unknown
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain after a total knee arthroplasty

Brief summary

Total morphine consumption within 24h after the surgery.

Detailed description

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, Plasmatic and cerebrospinal fluid concentration of Nefopam hydrochloride, Persistent postoperative pain - DN4 (or DN2 by phone), Persistent postoperative pain - DN4

Interventions

DRUGMORPHINE (CHLORHYDRATE) LAVOISIER 20 mg/ml
DRUGsolution injectable
DRUGSchweppes™
DRUGMORPHINE (SULFATE) LAVOISIER 50 mg/ml
DRUGMORPHINE (CHLORHYDRATE) AGUETTANT 0
DRUG1 mg/mL

Sponsors

Hospices Civils De Lyon
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Total morphine consumption within 24h after the surgery.

Secondary

MeasureTime frame
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, Plasmatic and cerebrospinal fluid concentration of Nefopam hydrochloride, Persistent postoperative pain - DN4 (or DN2 by phone), Persistent postoperative pain - DN4

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026