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

• Published in: International journal of pain Vol. 15; no. 1; pp. 12 - 18
• Main Authors: Yoo, Beom Seok, Park, Cheol Wung, Shin, Dong Ah, Park, Jung-Hoon, Yoo, Chai-Min, Lee, Woo-Joo, Yoon, Jae-Eon, An, Tae-Yong, Kim, Byung-Kwan, Lee, Jin-Seong
• Format: Journal Article
• Language: English
• Published: Korean Association for the Study of Pain, Korean Pain Intervention Society 01.06.2024; 대한통증연구학회
• Subjects: analgesics; diskectomy; drug delivery systems; lumbar vertebrae; pain; 마취과학
• ISSN: 2233-4793; 2233-4807
• DOI: 10.56718/ijp.24-003

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). In addition, there was no significant difference in the number of the patients presenting with no pain (NRS pain scores ≤; 3) between the two groups at 48 and 72 hours postoperatively (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.