The effect of wound instillation of a novel purified capsaicin formulation on postherniotomy pain: A double-blind, randomized, placebo-controlled study
The effect of wound instillation of a novel purified capsaicin formulation on postherniotomy pain: A double-blind, randomized, placebo-controlled study
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DOI：
10.1213/ane.0b013e31816b94c9
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发表时间：
2008-07-01
影响因子：
5.7
通讯作者：
Kehlet, Henrik
中科院分区：
文献类型：
--
作者：
Aasvang, Eske K.;Hansen, Jeanette B.;Kehlet, Henrik
背景：急性术后疼痛是大多数外科手术后常见的。尽管有许多镇痛药可供选择，但术后疼痛管理往往不令人满意。精制辣椒碱（ALGRX 4975 98%纯）已在体外、临床前和临床研究中证明了对C纤维功能的长期抑制，并且可能是术后疼痛管理的有效辅助。我们进行了一项单中心，随机，双盲，术中伤口单次滴注1000 μ g超纯化辣椒碱的镇痛效果的安慰剂对照研究（ALGRX 4975）在41例成年男性患者中进行开放式补片腹股沟疝修补术后的随访。主要终点是手术后第一周内平均每日视觉模拟量表（VAS）疼痛评分，评估为曲线下面积（AUC）。疼痛记录在疼痛日记中，每天两次，持续4周。术前和术后1周进行体格检查和实验室检查，并记录28天内的不良事件。记录不良事件。结果：术后3 d VAS AUC显著降低（P < 0.05），但术后1周和4周VAS AUC无显著性差异。NONMEM混合效应分析显示，在前4天，辣椒素组的疼痛评分显著降低（P < 0.05）。没有临床意义的严重不良事件进行观察，虽然在辣椒素治疗group.CONCLUSION：在一个定义明确的镇痛协议标准的设置，VAS AUC分析和混合效应分析显示，辣椒素相对于安慰剂的上级镇痛在腹股沟疝修补术后的第3-4天。
BACKGROUND: Acute postoperative pain is common after most surgical procedures. Despite the availability of many analgesic options, postoperative pain management is often unsatisfactory. Purified capsaicin (ALGRX 4975 98% pure) has demonstrated prolong inhibition of C-fiber function in in vitro, preclinical, and clinical studies, and may be an effective adjunct to postoperative pain management.METHODS: We performed a single-center, randomized, double-blind, placebo-controlled study of the analgesic efficacy of a single intraoperative wound instillation of 1000 mu g ultrapurified capsaicin (ALGRX 4975) after open mesh groin hernia repair in 41 adult male patients. The primary end-point was average daily visual analog scale (VAS) pain scores during the first week after surgery assessed as area under the curve (AUC). Pain was recorded twice daily in a pain diary for 4 wk. Physical examination and laboratory tests were done before and I wk after surgery, together with recordings of adverse events up to 28 days. Adverse events were recorded. Data were also analyzed using a mixed-effects analysis with NONMEM.RESULTS: VAS AUC was significantly lower during the first 3 days postoperatively (P < 0.05), but not for the whole I or 4 wk postoperatively. Mixed-effects analysis with NONMEM revealed that pain scores were significantly lower (P < 0.05) in the capsaicin group during the first 4 days. No clinically significant serious adverse events were observed, although a mild transient increase in liver enzymes was seen more often in the capsaicin-treated group.CONCLUSION: In the setting of a well-defined analgesic protocol standard, VAS AUC analysis and a mixed-effect analysis showed superior analgesia of capsaicin relative to placebo during the first 3-4 days after inguinal hernia repair.