A Prospective, Single-Center, Single-Blind, Randomized, Confirmatory, Controlled Trial to Assess the Efficacy and Safety of PF-72 Combined with 0.75% Ropivacaine Hydrochloride in Patients Undergoing Single-Level Lumbar Discectomy

Abstract

Background : We conducted this study to assess the efficacy and safety of PF-72 (TGel Bio Co. Ltd., Seoul, Korea) combined with 0.75% ropivacaine hydrochloride in relieving the postoperative pain in patients undergoing single-level lumbar discectomy. Methods : A total of 95 eligible patients were randomized to either the trial group (n = 47; PF-72 combined with 0.75% ropivacaine hydrochloride) or the control group (n = 48; ramosetron hydrochloride 0.3 mg). The patients were monitored at 3, 6, 24, 48 and 72 hours postoperatively, for which the cumulative area under the curve (AUC0-72) of NRS pain scores was plotted and the amount of rescue analgesics used at 6, 24, 48 and 72 hours or 24, 48 and 72 hours postoperatively. Moreover, incidences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were analyzed. Results : The amount of analgesics used and the AUC0-72 of the NRS pain scores was significantly smaller and the NRS pain scores were significantly lower in the trial group as compared with the control group (P 0.05). There were no significant differences in the incidences of TEAEs and SAEs between the two groups (P > 0.05). Conclusion : s: PF-72 combined with 0.75% ropivacaine hydrochloride is an effective, safe drug delivery system.

Keywords

• analgesics
• diskectomy
• drug delivery systems
• lumbar vertebrae
• pain