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• Clinical research

  A triple-blind, randomized, placebo-controlled Phase II trial (NCT03599089) was conducted to assess the safety and efficacy of vocacapsaicin for postoperative pain management. A total of 147 patients undergoing bunionectomy were randomly assigned into four groups to receive different concentrations of vocacapsaicin and placebo. The experimental groups were given vocacapsaicin at concentrations of 0.30mg/ml, 0.15mg/ml, and 0.05mg/ml; the control group was given a placebo. The results showed that the 0.30mg/ml vocacapsaicin group had significant effects in reducing resting pain, reducing opioid demand, reducing opioid consumption, and reducing pain within one week after surgery. Within two weeks postoperatively, the average numerical rating scale pain scores for both the placebo group and the 0.30mg/ml vocacapsaicin group in resting and walking conditions demonstrated that the vocacapsaicin group had an initial increase in pain postoperatively, but then showed a sustained analgesic effect. Patients treated with vocacapsaicin (0.30mg/ml) discontinued opioid use earlier than those in the placebo group, with patients treated with vocacapsaicin no longer requiring opioids after five days. In summary, a single topical administration of vocacapsaicin during surgery can significantly reduce pain and opioid consumption for at least 96 hours postoperatively, with good tolerability and safety. ;

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