Post-operative Analgesic Effect of Oral Nefopam (NefPO)
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- STATUS
- Recruiting
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- End date
- Nov 15, 2023
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- participants needed
- 58
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- sponsor
- Hospices Civils de Lyon
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.
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 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).
Details
| Condition | Postoperative Pain After a High Tibial Osteotomy |
|---|---|
| Treatment | Placebo, Oral nefopam |
| Clinical Study Identifier | NCT04576078 |
| Sponsor | Hospices Civils de Lyon |
| Last Modified on | 23 March 2022 |
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