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Int J Pain

Published online March 20, 2024

Copyright © The Korean Association for the Study of Pain.

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

Beom Seok Yoo1, Cheol Wung Park1, Dong Ah Shin2, Jung-Hoon Park1, Chai-Min Yoo1, Woo-Joo Lee1, Jae-Eon Yoon1, Tae-Yong An1, Byung-Kwan Kim1, Jin-Seong Lee1

1MD Spine Center, Daejeon Woori Hospital, Daejeon, Republic of Korea
2Department of Neurosurgery, Spine and Spinal Cord Institute, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea

Correspondence to:Cheol Wung Park, MD Spine Center, Daejeon Woori Hospital, 70 Munjeong-ro 48 beon-gil, Seo-gu, Daejeon 35262, Republic of Korea. Tel: +82-42-829-1008, Fax: +82-42-489-6216, E-mail: endospine@naver.com
Dong Ah Shin, Department of Neurosurgery, Spine and Spinal Cord Institute, Severance Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea. Tel: +82-2-2229-3390, Fax: +82-2-3461-9229, E-mail: cistern@yuhs.ac

Received: February 13, 2024; Revised: February 19, 2024; Accepted: February 21, 2024

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). 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).
Conclusions: PF-72 combined with 0.75% ropivacaine hydrochloride is an effective, safe drug delivery system.

Keywordsanalgesics, diskectomy, drug delivery systems, lumbar vertebrae, pain.

The Korean Association for the Study of Pain

Vol.14 No.2
December 2023

pISSN 2233-4793
eISSN 2233-4807

Frequency: Semi-Annual

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