Kushner David M, LaGalbo Regina, Connor Joseph P, Chappell Rick, Stewart Sarah L, Hartenbach Ellen M
Department of Gynecologic Oncology, University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792, USA.
Obstet Gynecol. 2005 Aug;106(2):227-33. doi: 10.1097/01.AOG.0000171111.68015.af.
The aim of the current study was to evaluate the safety and efficacy of a widely available bupivacaine continuous wound infusion system in gynecologic oncology patients undergoing laparotomy.
A prospective, randomized, double-blind, placebo-controlled trial was performed. After closure of the fascia, flexible soaker catheters were placed in the deep subcutaneous space. The infusion pump was filled with 290 mL of either 0.5% bupivacaine or normal saline, to infuse over 72 hours. Daily assessments of pain scores utilized the Wisconsin Brief Pain Inventory. All patients received intravenous narcotics via patient-controlled devices.
Eighty surgeries were evaluated in a total of 79 women (40 per arm). Mean age was 56 years, with 79% having invasive gynecologic pathology. The two groups were not significantly different in terms of type of surgery, length of incision, estimated blood loss, operative time, or medical history. Postoperative outcomes, including wound toxicity, time to flatus, and hospital stay, did not differ. Study patients averaged 75 mg intravenously and 107 mg total narcotic use (morphine equivalent), whereas controls averaged 60 mg intravenously and 86 mg total (P = .40 intravenously; P = .25 total). Acetaminophen and intravenous ketorolac consumption were equal between groups. The Brief Pain Inventory score for "current pain" was 2.84 for bupivacaine patients and 3.14 for controls (P = .46; least = 0, most = 10). There was no individual postoperative day when "current pain" BPI scores differed. "Worst pain" and "least pain" Brief Pain Inventory scores showed similar results.
The results suggest that although the continuous infusion system seems safe, it is not efficacious in this patient population.
本研究旨在评估一种广泛应用的布比卡因持续伤口灌注系统在接受剖腹手术的妇科肿瘤患者中的安全性和有效性。
进行了一项前瞻性、随机、双盲、安慰剂对照试验。在筋膜闭合后,将柔性吸收导管置于皮下深层空间。输液泵中填充290 mL的0.5%布比卡因或生理盐水,持续输注72小时。使用威斯康星简明疼痛量表每日评估疼痛评分。所有患者均通过患者自控装置接受静脉注射麻醉剂。
共对79名女性进行了80例手术评估(每组40例)。平均年龄为56岁,7�%患有侵袭性妇科疾病。两组在手术类型、切口长度、估计失血量、手术时间或病史方面无显著差异。术后结果,包括伤口毒性、排气时间和住院时间,无差异。研究组患者平均静脉注射麻醉剂75 mg,总麻醉剂使用量(吗啡当量)为107 mg,而对照组平均静脉注射60 mg,总量为86 mg(静脉注射P = 0.40;总量P = 0.25)。两组对乙酰氨基酚和静脉注射酮咯酸的消耗量相等。布比卡因组患者“当前疼痛”的简明疼痛量表评分为2.84,对照组为3.14(P = 0.46;最低 = 0,最高 = 10)。术后各天“当前疼痛”的简明疼痛量表评分均无差异。“最痛”和“最轻疼痛”的简明疼痛量表评分结果相似。
结果表明,尽管持续灌注系统似乎安全,但在该患者群体中无效。