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Abstract：
Background/Objectives: Immediate breast reconstruction surgery (BRS) often leads to significant postoperative pain, necessitating effective analgesia. This study aimed to compare the analgesic efficacy of patient-controlled analgesia (PCA) containing nefopam with that of PCA containing opioids alone in patients undergoing BRS. Methods: A prospective, double-blind, randomized controlled trial was conducted on 120 patients undergoing immediate BRS after mastectomy. Patients were randomly allocated to receive PCA with fentanyl alone (Group F: fentanyl 10 mcg/kg), fentanyl and nefopam (Group FN: fentanyl 5 mcg/kg + nefopam 1 mg/kg), or nefopam alone (Group N: nefopam 2 mg/kg). Pain intensity (expressed in VASr and VASm), opioid consumption, and opioid-related complications were assessed. Results: PCA with nefopam, either alone or in combination with opioids, demonstrated non-inferior analgesic efficacy compared to PCA with fentanyl alone. At 24 h postoperatively, the VASr scores were 2.9 ± 1.0 in Group F, 3.1 ± 1.2 in Group FN, and 2.8 ± 0.9 in Group N (p = 0.501). At the same timepoint, the VASm scores were 4.1 ± 1.2 in Group F, 4.5 ± 1.5 in Group FN, and 3.8 ± 1.4 in Group N (p = 0.129). Significant differences among the three groups were observed at all timepoints except for PACU in terms of the total opioid consumption (p < 0.0001). However, there were no significant differences in opioid-related complications among the three groups. Conclusions: PCA with nefopam, whether alone or in combination with opioids, offers non-inferior analgesic efficacy compared to PCA with fentanyl alone in patients undergoing immediate BRS.
摘要：
背景/目的：即刻乳房重建手术（BRS）通常会导致明显的术后疼痛，需要有效的镇痛。这项研究旨在比较在接受BRS的患者中，含奈福泮的患者自控镇痛（PCA）与仅含阿片类药物的PCA的镇痛效果。方法：前瞻性，双盲,我们对120例接受乳房切除术后即刻BRS的患者进行了随机对照试验.患者被随机分配接受PCA单独使用芬太尼（F组：芬太尼10mcg/kg），芬太尼和奈福泮（FN组：芬太尼5mcg/kg+奈福泮1mg/kg），或单独使用奈福泮（N组：奈福泮2mg/kg）。疼痛强度（以VASr和VASm表示），阿片类药物的消费，并评估阿片类药物相关并发症.结果：PCA与nefopam，单独或与阿片类药物联合使用，与单独使用芬太尼的PCA相比，镇痛效果不差。术后24小时，F组VASr评分为2.9±1.0，组FN中3.1±1.2,N组2.8±0.9(p=0.501)。在同一时间点，F组VASm评分为4.1±1.2,组FN中的4.5±1.5，N组3.8±1.4(p=0.129)。在除PACU外的所有时间点观察到三组之间在总阿片类药物消耗方面的显著差异(p<0.0001)。然而,三组间阿片类药物相关并发症无显著差异.结论：用奈福泮进行PCA，无论是单独还是与阿片类药物联合使用，在立即接受BRS的患者中，与单独使用芬太尼的PCA相比，镇痛效果不差。
