Department of Orthopedic Surgery, Zuyderland Medical Centre, dr H vd Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands.
Department of Clinical Pharmacy and Toxicology, Zuyderland Medical Centre, Sittard-Geleen, The Netherlands.
Knee Surg Sports Traumatol Arthrosc. 2017 Sep;25(9):2778-2783. doi: 10.1007/s00167-015-3723-4. Epub 2015 Jul 26.
Local infiltration analgesia (LIA) is widely applied in patients undergoing total knee arthroplasty (TKA). In daily practice, adrenaline is added to the LIA mixture to achieve vasoconstriction. However, adrenaline has some possible negative side effects (e.g. tissue necrosis). This trial investigated whether ropivacaine alone is at least as effective for postoperative pain relief after LIA.
Fifty patients scheduled for primary TKA were included in this prospective randomized, double-blind, controlled pilot study receiving high-volume (150 mL) single-shot intra-capsular LIA with ropivacaine (2 %) with (Ropi+) or without (Ropi-) adrenaline (0.01 %). All patients received the same pre-, peri- and postoperative care with multimodal oral pain protocol. Postoperative pain was assessed before and after the first mobilization and during the first 48 h postoperative using the visual analogue scale (VAS). Secondary outcomes were rescue medication use, early mobilization, length of hospital stay, adverse events (AE's) and readmission rates. Patient reported outcomes measures (PROMS); Oxford Knee Score and WOMAC, were obtained preoperative and 3 months postoperative.
VAS scores were not significantly different before (n.s.) and after the first mobilization (n.s.), neither over the first 48 h postoperative (n.s.). Patients who needed rescue medication (n.s.), who mobilized <6 h postoperative (n.s.), who were discharged before postoperative day 3 (n.s.), AE's and readmission rate (n.s.) were comparable between both groups. At 3-month follow-up, PROMS significantly improved within both groups.
To prevent possible negative side effects (e.g. tissue necrosis), adrenaline should be omitted from the LIA mixture. Single-shot LIA with ropivacaine alone results in clinical acceptable adequate pain control and can be used in daily TKA practice.
Randomized, double-blind, prospective clinical trial, Level I.
局部浸润镇痛（LIA）广泛应用于全膝关节置换术（TKA）患者。在日常实践中，肾上腺素被添加到 LIA 混合物中以实现血管收缩。然而，肾上腺素可能有一些负面的副作用（例如组织坏死）。本试验研究了罗哌卡因单独用于 LIA 后是否至少同样有效缓解术后疼痛。
本前瞻性随机、双盲、对照试验纳入了 50 例拟行初次 TKA 的患者，接受高容量（150ml）单次关节内囊内罗哌卡因（2%）LIA，分别加（Ropi+）或不加（Ropi-）肾上腺素（0.01%）。所有患者均接受相同的术前、围术期和术后多模式口服疼痛方案治疗。术后疼痛采用视觉模拟评分（VAS）在第一次活动前、第一次活动后和术后 48 小时内进行评估。次要结局包括使用解救药物、早期活动、住院时间、不良事件（AE）和再入院率。患者报告的结局测量（PROMs）；牛津膝关节评分和 WOMAC 在术前和术后 3 个月时获得。
VAS 评分在第一次活动前（无统计学差异）和第一次活动后（无统计学差异）以及术后 48 小时内（无统计学差异）均无显著差异。需要解救药物（无统计学差异）、术后 6 小时内活动（无统计学差异）、术后第 3 天前出院（无统计学差异）、AE 和再入院率（无统计学差异）的患者在两组间相似。在 3 个月随访时，两组的 PROMs 均显著改善。
为了防止可能的负面副作用（例如组织坏死），肾上腺素应从 LIA 混合物中去除。单独使用罗哌卡因进行单次 LIA 可实现临床可接受的充分疼痛控制，可用于日常 TKA 实践。
随机、双盲、前瞻性临床试验，I 级。
