Ekman Evan F, Wahba Mona, Ancona Frank
Southern Orthopedic Sports Medicine, Columbia, South Carolina 29204, USA.
Arthroscopy. 2006 Jun;22(6):635-42. doi: 10.1016/j.arthro.2006.03.012.
To examine whether celecoxib, administered perioperatively, reduces opioid consumption and opioid-related adverse effects, and provides effective analgesia, in patients undergoing ambulatory arthroscopic knee meniscectomy.
Patients (> or = 18 years) with diagnosed knee meniscus disease were given celecoxib (400 mg; n = 99) or placebo (n = 101) 1 hour before they underwent arthroscopic knee surgery; this was followed by celecoxib (200 mg) or placebo given postoperatively at their first request for pain medication. Surgery was performed with patients under general anesthesia (fentanyl, 1 to 3 microg/kg plus 0.25% intra-articular bupivacaine, 10 to 20 mL) administered at the index joint. Every 4 to 6 hours, patients were allowed 1 to 2 tablets of hydrocodone bitartrate 5 mg/acetaminophen 500 mg (and optional opioids as needed). All efficacy analyses were conducted in the modified intent-to-treat population.
In the 24 hours following surgery, total opioid consumption was significantly reduced in the celecoxib group (3.6 tablets) compared with the placebo group (4.6 tablets; P = .009). Celecoxib was associated with significant reductions in opioid consumption compared with placebo at 10 to 12 hours (P = .005) and at 12 to 24 hours (P = .012). The percentage of placebo-treated patients (41%) who required opioid analgesics was significantly greater than the percentage of celecoxib-treated patients who required opioids (22%; P = .008) at 10 to 12 hours. Adverse events (AEs) were experienced by more patients in the placebo group (37%) than in the celecoxib group (18%). Incidences of opioid-related events, such as central nervous system disorders (12% v 3%, respectively) and constipation (5% v 1%, respectively), were higher in placebo-treated patients than in those given celecoxib.
Perioperative administration of celecoxib plus optional opioids reduces the use of opioids and the occurrence of opioid-related AEs compared with treatment with placebo plus optional opioids given to patients undergoing arthroscopic knee meniscectomy.
Level I, randomized, double-blind, placebo-controlled, parallel-group study.
探讨围手术期给予塞来昔布是否能减少门诊膝关节镜下半月板切除术患者的阿片类药物用量及阿片类药物相关不良反应，并提供有效的镇痛效果。
诊断为膝关节半月板疾病的患者（≥18岁）在接受膝关节镜手术前1小时给予塞来昔布（400mg；n = 99）或安慰剂（n = 101）；随后在患者首次要求使用止痛药物时，术后给予塞来昔布（200mg）或安慰剂。手术在全身麻醉（芬太尼，1至3μg/kg加0.25%关节内布比卡因，10至20mL）下于索引关节进行。每4至6小时，允许患者服用1至2片酒石酸氢可酮5mg/对乙酰氨基酚500mg（以及必要时的其他阿片类药物）。所有疗效分析均在改良意向性治疗人群中进行。
术后24小时内，塞来昔布组的阿片类药物总用量（3.6片）明显低于安慰剂组（4.6片；P = 0.009）。与安慰剂相比，塞来昔布在10至12小时（P = 0.005）和12至24小时（P = 0.012）时阿片类药物用量显著减少。在10至12小时时，需要阿片类镇痛药物的安慰剂治疗患者百分比（41%）显著高于塞来昔布治疗患者百分比（22%；P = 0.008）。安慰剂组发生不良事件（AE）的患者多于塞来昔布组（37%对18%）。安慰剂治疗患者中阿片类药物相关事件的发生率，如中枢神经系统疾病（分别为12%对3%）和便秘（分别为5%对1%），高于给予塞来昔布的患者。
与接受膝关节镜半月板切除术的患者使用安慰剂加必要时的阿片类药物治疗相比，并使用塞来昔布加必要时的阿片类药物进行围手术期给药可减少阿片类药物的使用及阿片类药物相关AE的发生。
I级，随机、双盲、安慰剂对照、平行组研究。
