Post-operative Analgesic Effect of Oral Nefopam: a Randomized Controlled Trial
Status:
Not yet recruiting
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
Summary
High tibial osteotomy is a common procedure in orthopedic surgery; it is highly standardized
(incision location and size, the volume of periosteal lesion, implanted material). It is
associated with short recovery period but intense postoperative pain during first 24 hours.
The surgical wound has a comprehensive innervation by saphenous and a terminal muscular
branches of tibial nerve. These conditions allow reproducible measurements of analgesic drugs
effects in postoperative period.
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.
We 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 high tibial osteotomy. 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).