Zhao Ying, Mu Hailing, Zhang Jingjing, Lu Yao
Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230022, P.R. China.
Department of Anesthesiology, The Second People's Hospital of Wuhu, Wuhu, Anhui 241001, P.R. China.
Exp Ther Med. 2023 Aug 22;26(4):475. doi: 10.3892/etm.2023.12174. eCollection 2023 Oct.
Remifentanil-induced hyperalgesia (RIH) is a common and complicated issue in patients undergoing laparoscopic cholecystectomy (LC), which significantly reduces patient satisfaction. The present trial was designed to clarify the individual and combined effects of flurbiprofen-axetil and nalbuphine on remifentanil-induced hyperalgesia. This randomized double-blind clinical trial included 120 adult patients who underwent LC at The Second People's Hospital of Wuhu. The individuals were randomized into a flurbiprofen-axetil group (F group), nalbuphine group (N group), flurbiprofen-axetil combined with nalbuphine group (FN group) and saline group (S group). The four groups were given flurbiprofen-axetil (50 mg, iv.), nalbuphine (0.1 mg/kg, iv.), flurbiprofen-axetil (50 mg, iv.) combined with nalbuphine (0.1 mg/kg, iv.) or normal saline respectively prior to skin incision. The primary outcome was the postoperative mechanical pain thresholds at the inner forearm and peri-incisional area. The secondary outcomes were the visual analog scale (VAS) and Ramsay sedation scale at 0.5, 1, 4 and 24 h after surgery, and any other adverse events. The pain threshold of the medial forearm in the FN group did not differ from that in the F and N groups at 24 h after surgery (P=0.310 and P=0.910, respectively). However, the pain threshold around the incision in FN group was significantly lower than that in F and N groups 24 h after surgery (P=0.001). The VAS of the F group, N group and FN group were all significantly lower than that in the S group at 0.5, 1 and 24 h after surgery (P<0.001). No significant differences were observed in the incidence of adverse events between the four groups. Single flurbiprofen-axetil and single nalbuphine effectively prevented RIH 24 h after surgery in LC. The combination of the two analgesic drugs, with different mechanisms of action, was not superior to single therapy. The present study was registered with the Chinese Clinical Trial Registry (registration no. ChiCTR2100045347).
瑞芬太尼诱发的痛觉过敏（RIH）是接受腹腔镜胆囊切除术（LC）患者中常见且复杂的问题，这显著降低了患者满意度。本试验旨在阐明氟比洛芬酯和纳布啡对瑞芬太尼诱发痛觉过敏的个体及联合作用。这项随机双盲临床试验纳入了120例在芜湖市第二人民医院接受LC的成年患者。将这些个体随机分为氟比洛芬酯组（F组）、纳布啡组（N组）、氟比洛芬酯联合纳布啡组（FN组）和生理盐水组（S组）。在皮肤切开前，四组分别给予氟比洛芬酯（50 mg，静脉注射）、纳布啡（0.1 mg/kg，静脉注射）、氟比洛芬酯（50 mg，静脉注射）联合纳布啡（0.1 mg/kg，静脉注射）或生理盐水。主要结局是术后前臂内侧和切口周围区域的机械性疼痛阈值。次要结局是术后0.5、1、4和24小时的视觉模拟评分（VAS）和Ramsay镇静评分，以及任何其他不良事件。术后24小时，FN组前臂内侧的疼痛阈值与F组和N组相比无差异（分别为P = 0.310和P = 0.910）。然而，术后24小时，FN组切口周围的疼痛阈值显著低于F组和N组（P = 0.001）。术后0.5、1和24小时，F组、N组和FN组的VAS均显著低于S组（P < 0.001）。四组之间不良事件发生率未观察到显著差异。单剂量氟比洛芬酯和单剂量纳布啡可有效预防LC术后24小时的RIH。两种作用机制不同的镇痛药物联合使用并不优于单一治疗。本研究已在中国临床试验注册中心注册（注册号：ChiCTR2100045347）。
