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鞘内注射两种剂量的纳布啡可减少全膝关节置换术后的阿片类药物使用量及疼痛:一项随机对照试验。

Intrathecal nalbuphine at two doses reduces opioid use and pain after total knee arthroplasty: a randomized controlled trial.

作者信息

Nonsri Chawisachon, Kositanurit Inthiporn, Tewaritruangsri Apirak, Jeephet Kornthip, Rattanaprichavej Piti, Laoruengthana Artit

机构信息

Naresuan University, Phitsanulok, Thailand.

Nakhonpathom hospital, Nakhonpathom, Thailand.

出版信息

Eur J Orthop Surg Traumatol. 2025 Aug 8;35(1):341. doi: 10.1007/s00590-025-04459-2.

Abstract

PURPOSE

This study aimed to assess the efficacy of different-dose intrathecal nalbuphine (ITN) in addition to adductor canal block (ACB) and its associated side effects.

METHODS

This prospective randomized double-blinded controlled trial recruited 42 patients undergoing TKA at Naresuan University Hospital who received spinal anesthesia and ACB into three groups, each with 14 patients: Group A (control), Group B (additional ITN 0.8 mg), and Group C (additional ITN 1.2 mg). The primary outcome was the numeric rating scale (NRS) at rest and during movement at various time points. The secondary outcomes included the cumulative morphine use (CMU) and side effects.

RESULTS

Forty-two patients (group A = 14; group B = 14; group C = 14) were randomized. All patients were analyzed. The group C had significantly lower NRS at rest at 6, 12, 24, and 48 h postoperatively, and significantly lower NRS during movement at 6 and 36 h postoperatively when compared to group A. There was no significant difference in NRS between group C and B, or between group B and A. The group B and C required significantly less CMU than the group A during the first 24, 48, and 72 h after TKA. The side effects, which included nausea, vomiting, drowsiness, respiratory depression, and shivering, were not significantly different among the groups.

CONCLUSION

Additional ITN, both 0.8 and 1.2 mg doses, effectively reduces CMU during the first 72 h after TKA. Given higher-dose ITN up to 1.2 mg provides benefit by further reducing pain scores, without increased side effects.

TRIAL REGISTRATION CLINICAL TRIALS

TCTR20241012005, October 12, 2024.

摘要

目的

本研究旨在评估除收肌管阻滞(ACB)外不同剂量鞘内注射纳布啡(ITN)的疗效及其相关副作用。

方法

这项前瞻性随机双盲对照试验招募了42例在那黎宣大学医院接受全膝关节置换术(TKA)的患者,这些患者接受了脊髓麻醉和ACB,并被分为三组,每组14例:A组(对照组)、B组(额外注射ITN 0.8毫克)和C组(额外注射ITN 1.2毫克)。主要结局是不同时间点静息和活动时的数字评分量表(NRS)。次要结局包括吗啡累积用量(CMU)和副作用。

结果

42例患者(A组 = 14例;B组 = 14例;C组 = 14例)被随机分组。所有患者均纳入分析。与A组相比,C组术后6、12、24和48小时静息时的NRS显著更低,术后6和36小时活动时的NRS也显著更低。C组和B组之间、B组和A组之间的NRS无显著差异。B组和C组在TKA后的前24、48和72小时所需的CMU明显少于A组。包括恶心、呕吐、嗜睡、呼吸抑制和寒战在内的副作用在各组之间无显著差异。

结论

0.8毫克和1.2毫克剂量的额外ITN均可有效降低TKA后前72小时的CMU。给予高达1.2毫克的高剂量ITN可通过进一步降低疼痛评分带来益处,且不会增加副作用。

试验注册 临床试验:TCTR20241012005,2024年10月12日。

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