Department of Orthopedic surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.
Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, People's Republic of China.
J Arthroplasty. 2024 Aug;39(8):2061-2067. doi: 10.1016/j.arth.2024.02.059. Epub 2024 Feb 23.
Multimodal analgesia is central to pain management after total knee arthroplasty (TKA). This study aimed to evaluate the efficacy of adding oral nefopam to multimodal analgesia for post-TKA pain management.
In this prospective, double-blind, placebo-controlled, randomized trial, 100 patients who underwent TKA at our hospital were randomized to either the nefopam or the control group. After surgery, patients in the nefopam group received 200 mg of celecoxib, 150 mg of pregabalin, and 40 mg of nefopam twice daily to control postoperative pain. Patients in the control group received 200 mg of celecoxib, 150 mg of pregabalin, and a placebo. Oxycodone hydrochloride (10 mg) was used as the rescue analgesic. If the pain remained poorly controlled, 10 mg of morphine hydrochloride was injected subcutaneously as a secondary rescue analgesic. The primary outcome was the postoperative consumption of oxycodone and morphine as rescue analgesics. Secondary outcomes were postoperative pain assessed using the visual analogue scale (VAS), functional recovery assessed by the range of knee motion and ambulation distance, time until hospital discharge, indicators of liver function, and complication rates.
Patients in the nefopam group had significantly lower postoperative oxycodone and morphine consumption within 24 hours after surgery and during hospitalization, lower VAS pain scores at rest and during motion within 24 h after surgery, better functional recovery on postoperative days 1 and 2, and a shorter hospital stay. However, the absolute reduction in 0 to 24 h opioid consumption, VAS pain scores, and knee range of motion did not exceed the reported minimal clinically important difference. Both groups had similar indicators of liver function and complication rates.
Adding oral nefopam to multimodal analgesia resulted in statistically significant improvements in opioid consumption, VAS pain scores, and functional recovery. However, the amount of improvement may not be clinically important.
多模式镇痛是全膝关节置换术（TKA）后疼痛管理的核心。本研究旨在评估在多模式镇痛中加入口服奈福泮对 TKA 后疼痛管理的疗效。
在这项前瞻性、双盲、安慰剂对照、随机试验中，100 名在我院接受 TKA 的患者被随机分为奈福泮组或对照组。手术后，奈福泮组患者每天接受 200 毫克塞来昔布、150 毫克普瑞巴林和 40 毫克奈福泮两次，以控制术后疼痛。对照组患者接受 200 毫克塞来昔布、150 毫克普瑞巴林和安慰剂。盐酸羟考酮（10 毫克）用作解救性镇痛药。如果疼痛控制不佳，皮下注射 10 毫克盐酸吗啡作为二线解救性镇痛药。主要结局是术后使用羟考酮和吗啡作为解救性镇痛药的消耗量。次要结局是使用视觉模拟量表（VAS）评估术后疼痛、膝关节运动范围和步行距离评估功能恢复、出院时间、肝功能指标和并发症发生率。
奈福泮组患者术后 24 小时内和住院期间的术后羟考酮和吗啡消耗量显著降低，术后 24 小时内静息和运动时的 VAS 疼痛评分降低，术后第 1 天和第 2 天的功能恢复更好，住院时间更短。然而，0 至 24 小时内阿片类药物消耗量、VAS 疼痛评分和膝关节活动范围的绝对减少量并未超过报告的最小临床重要差异。两组患者的肝功能指标和并发症发生率相似。
在多模式镇痛中加入口服奈福泮可显著改善阿片类药物消耗、VAS 疼痛评分和功能恢复。然而，改善的程度可能没有临床意义。
