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From the *Section of Surgical Pathophysiology, the Juliane Marie Centre, Rigshospitalet, Copenhagen, Denmark; Ambulatory Surgical Clinic, Hørsholm Hospital, Hørsholm, Denmark; Anesiva, Inc., South San Francisco, California; and Department of Anesthesia, Ghent University Hospital; ||Department of Anesthesia, and ¶Heymans Institute of Pharmacology, Ghent University, Gent, Belgium.
Address correspondence and reprint requests to Eske Kvanner Aasvang, the Juliane Marie Centre, Section of Surgical Pathophysiology 4074, Rigshospitalet 2100, Copenhagen, Denmark. Address e-mail to eskeaasvang{at}rh.hosp.dk.
BACKGROUND: Acute postoperative pain is common after most surgical procedures. Despite the availability of many analgesic options, postoperative pain management is often unsatisfactory. Purified capsaicin (ALGRX 4975 98% pure) has demonstrated prolong inhibition of C-fiber function in in vitro, preclinical, and clinical studies, and may be an effective adjunct to postoperative pain management.
METHODS: We performed a single-center, randomized, double-blind, placebo-controlled study of the analgesic efficacy of a single intraoperative wound instillation of 1000 µg ultrapurified capsaicin (ALGRX 4975) after open mesh groin hernia repair in 41 adult male patients. The primary end-point was average daily visual analog scale (VAS) pain scores during the first week after surgery assessed as area under the curve (AUC). Pain was recorded twice daily in a pain diary for 4 wk. Physical examination and laboratory tests were done before and 1 wk after surgery, together with recordings of adverse events up to 28 days. Adverse events were recorded. Data were also analyzed using a mixed-effects analysis with NONMEM.
RESULTS: VAS AUC was significantly lower during the first 3 days postoperatively (P < 0.05), but not for the whole 1 or 4 wk postoperatively. Mixed-effects analysis with NONMEM revealed that pain scores were significantly lower (P < 0.05) in the capsaicin group during the first 4 days. No clinically significant serious adverse events were observed, although a mild transient increase in liver enzymes was seen more often in the capsaicin-treated group.
CONCLUSION: In the setting of a well-defined analgesic protocol standard, VAS AUC analysis and a mixed-effect analysis showed superior analgesia of capsaicin relative to placebo during the first 3–4 days after inguinal hernia repair.
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