TOPLINE:
Compared with placebo, administration of vocacapsaicin during bunionectomy reduces pain and decreases opioid consumption in the first 96 hours after surgery, with no local or systemic toxicity.
METHODOLOGY:
- This triple-blind, randomized, placebo-controlled trial included 147 patients undergoing bunionectomy.
- Patients were randomly assigned to receive 14 mL of either 0.05 mg/mL vocacapsaicin, 0.15 mg/mL vocacapsaicin, 0.30 mg/mL vocacapsaicin, or placebo at the surgical site during wound closure. Except for the study drug, all patients received identical perioperative analgesics.
- Patients were observed for 96 hours post-surgery, with follow-up visits on days 8, 15, and 29 to monitor for pain and adverse events.
- The primary endpoint was overall levels of pain at rest through the first 96 hours after surgery for the 0.30-mg/mL vocacapsaicin group.
- The secondary endpoints included the percentage of patients who did not require opioids and total opioid consumption through 96 hours, as well as pain scores during the first postoperative week.
TAKEAWAY:
- Vocacapsaicin (0.30 mg/mL) reduced pain at rest by 33% over the first 96 hours, compared with placebo (P = .005).
- Overall, 26% of patients who received the 0.30-mg/mL dose of vocacapsaicin did not require opioids through 96 hours compared with 5% of patients receiving placebo (P = .025).
- The researchers reported no difference in the rate, type, or severity of adverse events in the four study groups, consistent with typical recovery from bunionectomy.
IN PRACTICE:
“These data suggest that intraoperative administration of vocacapsaicin may provide substantial benefits in other surgical procedures,” the authors wrote.
SOURCE:
The study was led by Steven L. Shafer, MD, of the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University in Stanford, California, and published in the June 2024 issue of Anesthesiology.
LIMITATIONS:
The use of opioids was restricted from 0 to 96 hours after surgery, which did not reflect typical clinical practice. The range of vocacapsaicin concentrations tested may not have been extensive enough, as concentrations > 0.30 mg/mL might have provided better analgesia.
DISCLOSURES:
The study was supported by Concentric Analgesics. Two authors declared being employed by Concentric Analgesics. Other authors declared having several ties with many sources, including the funding agency.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.