Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, China.
Department of Biostatistics, Peking University First Hospital, Beijing, China.
PLoS One. 2019 Jul 1;14(7):e0219116. doi: 10.1371/journal.pone.0219116. eCollection 2019.
Patients after total knee arthroplasty (TKA) often develop moderate to severe pain. This study compared the analgesic effect of low-dose epidural morphine vs. a comparable saline injection in patients following TKA surgery.
This randomized, double-blinded, and placebo-controlled trial was conducted in a tertiary hospital in Beijing between July 1, 2017 and May 30, 2018. One hundred and ten patients following TKA under combined spinal-epidural anesthesia were randomized to receive either epidural morphine (2 mg diluted to 5 ml normal saline, the epidural morphine group) or placebo (5 ml normal saline, the placebo group). For all patients, single-injection femoral nerve block was performed, and a supplementary patient-controlled intravenous analgesia pump was provided. The severity of pain was assessed with the numerical rating scale (NRS, an 11-point scale where 0 = no pain and 10 = the worst pain) at 6, 12, 24, 36, and 48 hours after surgery. The primary endpoint was moderate to severe pain (NRS pain score ≥4) within 48 hours after surgery.
The percentage with moderate to severe pain within 48 hours was lower in the epidural morphine group than in the placebo group (58.2% [32/55] with epidural morphine vs. 76.4% [42/55] with placebo; OR 0.43, 95% CI 0.19-0.98; p = 0.042). Furthermore, the cumulative morphine consumption within 48 hours was lower (18.4±6.1 mg vs. 22.4±7.3 mg; p = 0.002) whereas the mental component summary score of 30-day quality of life was higher (63.8±2.9 vs. 61.9±4.2; p = 0.008) in the epidural morphine group than in the placebo group.
For patients following TKA, the addition of epidural morphine to single-injection femoral nerve block improves the quality of analgesia within 48 hours, without increasing adverse events.
ClinicalTrials.gov NCT03203967.
全膝关节置换术后(TKA)的患者常出现中重度疼痛。本研究比较了 TKA 术后硬膜外吗啡小剂量与等渗盐水注射的镇痛效果。
这是一项于 2017 年 7 月 1 日至 2018 年 5 月 30 日在北京一家三甲医院进行的随机、双盲、安慰剂对照试验。110 例接受腰硬联合麻醉下行 TKA 的患者被随机分为硬膜外吗啡组(2mg 吗啡稀释至 5ml 生理盐水)或安慰剂组(5ml 生理盐水)。所有患者均接受单次股神经阻滞,并提供补充的患者自控静脉镇痛泵。术后 6、12、24、36 和 48 小时采用数字评分量表(NRS,0 分表示无痛,10 分表示最痛)评估疼痛严重程度。主要终点是术后 48 小时内中重度疼痛(NRS 疼痛评分≥4)。
术后 48 小时内,硬膜外吗啡组中重度疼痛的比例低于安慰剂组(硬膜外吗啡组 58.2%[32/55],安慰剂组 76.4%[42/55];OR 0.43,95%CI 0.19-0.98;p=0.042)。此外,48 小时内累积吗啡消耗量较低(18.4±6.1mg vs. 22.4±7.3mg;p=0.002),硬膜外吗啡组术后 30 天生活质量的心理成分综合评分较高(63.8±2.9 vs. 61.9±4.2;p=0.008)。
对于 TKA 术后患者,单次股神经阻滞中加入硬膜外吗啡可在 48 小时内改善镇痛质量,且不增加不良事件。
ClinicalTrials.gov NCT03203967。