Division of Urology, Department of Surgery, Schulich School of Medicine & Dentistry, The University of Western Ontario, London, Ontario, Canada.
J Endourol. 2013 Mar;27(3):313-7. doi: 10.1089/end.2012.0191. Epub 2012 Nov 27.
This study evaluates the safety and efficacy of intravesical ropivacaine as part of a mulitimodal approach to the provision of analgesia after robot-assisted radical prostatectomy (RARP).
In this double-blind, placebo-controlled trial, 40 patients who were scheduled to undergo RARP for treatment of localized prostate cancer by a single surgeon (SP) were randomized 1:1 to receive either alkalinized intravesical ropivacaine or placebo (0.9% sodium chloride) at the completion of the vesicourethral anastomosis. A standardized general anesthetic was administered in each case. The primary outcome was a reduction in postoperative pain as assessed by a visual analogue scale (VAS). The need for alternate analgesic agents was recorded. Adverse events related to the administration of intravesical ropivacaine were documented prospectively.
No serious adverse events related to the administration of intravesical ropivacaine were identified. In the ropivacaine group, there was a significant reduction in the cumulative needed dose of ketoralac relative to placebo at 6 hours postoperatively. There was no statistically significant difference between the groups with regard to pain scores or narcotic use at any time point.
Intravesical administration of ropivacaine may be used safely in the context of RARP and is associated with a significant, albeit modest reduction in the need for supplementary analgesic agents, but did not result in a decrease in postoperative pain scores.
本研究评估了膀胱内罗哌卡因在机器人辅助根治性前列腺切除术(RARP)后提供镇痛的多模式方法中的安全性和有效性。
在这项双盲、安慰剂对照试验中,40 名因局部前列腺癌接受由单一外科医生(SP)进行的 RARP 的患者,按照 1:1 的比例随机分配接受膀胱内罗哌卡因或安慰剂(0.9%氯化钠),在完成膀胱输尿管吻合术后。在每种情况下均给予标准化的全身麻醉。主要结局是通过视觉模拟评分(VAS)评估术后疼痛的减轻程度。记录了对替代镇痛药物的需求。前瞻性记录了与膀胱内罗哌卡因给药相关的不良事件。
未发现与膀胱内罗哌卡因给药相关的严重不良事件。在罗哌卡因组中,与安慰剂相比,术后 6 小时需要的酮咯酸累积剂量显著减少。两组在任何时间点的疼痛评分或麻醉药物使用均无统计学差异。
在 RARP 背景下,膀胱内给予罗哌卡因是安全的,与补充镇痛药物的需求显著减少相关,尽管程度较轻,但并未导致术后疼痛评分降低。