Staals Lonneke M, Dogger Jaap, Keyzer-Dekker Claudia, Boerlage Anneke A, Bokhorst Eric F, van Wijk Jan J, Scheepe Jeroen R, van Dijk Monique, van Rosmalen Joost, de Wildt Saskia N
Department of Anesthesiology, Erasmus MC Sophia Children's Hospital, University Medical Center Rotterdam, Dr. Molewaterplein 40, PO Box 2060, 3000 CB, Rotterdam, The Netherlands.
Department of Pediatric Surgery, Erasmus MC Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands.
Paediatr Drugs. 2025 Sep;27(5):593-604. doi: 10.1007/s40272-025-00700-x. Epub 2025 Jun 4.
Wound catheter infusion (WCI) with local anesthetics provides effective postoperative analgesia in adults, without adverse effects on wound healing. Studies on WCI in infants are scarce. The aim of this study was to investigate the efficacy and safety of WCI with ropivacaine as treatment for postoperative pain in infants.
We conducted a prospective, randomized, double-blind, placebo-controlled trial including children aged < 1 year undergoing open abdominal surgery. Informed consent was obtained. All children received a wound catheter at the end of surgery and were randomized for treatment with either ropivacaine (bolus dose of 2 mg/kg and continuous infusion of 0.2 mg/kg/h) (R-group) or placebo (C-group), for 72 h postoperatively. The C-group received morphine 100 mcg/kg intravenously at the end of surgery, the R-group received placebo. Standard analgesia postoperatively was paracetamol intravenously and rescue morphine intravenously. Primary outcome was the cumulative amount of morphine (mcg/kg) administered in the first 48 hours postoperatively. Secondary outcomes were the number of patients needing morphine, area under the curve over 24 hours of COMFORT-B and Numeric Rating Scale pain scores, incidence of adverse events, and plasma concentrations of ropivacaine.
After inclusion of 30 patients, the study was discontinued because of slow recruitment. In two cases, the wound catheter was accidentally displaced directly after surgery, therefore data of 28 children were analyzed (14 R-group, 14 C-group). Median [interquartile range] cumulative amount of morphine (mcg/kg) administered within 48 hours postoperatively was 0.0 [0.0-642.2] in the R-group, compared with 240.1 [15.1-759.0] in the C-group (P = 0.068). In the R-group, 6/14 children required morphine compared with 13/14 in the C-group (P = 0.013). Pain scores were not significantly different between groups. Plasma concentrations of ropivacaine stayed below toxic thresholds.
Cumulative morphine use postoperatively was not significantly different between infants receiving WCI with ropivacaine or placebo, although a lower number in the R-group required morphine. Wound catheter infusion provided adequate analgesia, with no signs of local anesthetic toxicity. The study may have been underpowered because of early discontinuation.
The study was registered in EudraCT (2015-002209-12), and the Dutch Trial Registry NTR6130 on 23 November, 2016 (International Clinical Trials Registry Platform NL-OMON20504).
伤口导管输注（WCI）局部麻醉药可为成人提供有效的术后镇痛，且对伤口愈合无不良影响。关于婴儿WCI的研究较少。本研究旨在探讨罗哌卡因伤口导管输注用于婴儿术后疼痛治疗的有效性和安全性。
我们进行了一项前瞻性、随机、双盲、安慰剂对照试验，纳入年龄小于1岁的接受开腹手术的儿童。获得了知情同意。所有儿童在手术结束时均置入伤口导管，并随机分为罗哌卡因组（负荷剂量2mg/kg，持续输注0.2mg/kg/h）（R组）或安慰剂组（C组），术后治疗72小时。C组在手术结束时静脉注射吗啡100μg/kg，R组接受安慰剂。术后标准镇痛为静脉注射对乙酰氨基酚和静脉注射解救用吗啡。主要结局是术后48小时内静脉注射吗啡的累积量（μg/kg）。次要结局包括需要使用吗啡的患者数量、COMFORT - B量表和数字评分量表疼痛评分24小时曲线下面积、不良事件发生率以及罗哌卡因的血浆浓度。
纳入30例患者后，由于入组缓慢，研究提前终止。有2例患者在术后伤口导管意外移位，因此对28例儿童的数据进行了分析（14例R组，14例C组）。术后48小时内，R组静脉注射吗啡的累积量中位数[四分位间距]为0.0[0.0 - 642.2]μg/kg，C组为240.1[15.1 - 759.0]μg/kg（P = 0.068）。R组中6/14的儿童需要使用吗啡，而C组为13/14（P = 0.013）。两组间疼痛评分无显著差异。罗哌卡因的血浆浓度保持在中毒阈值以下。
接受罗哌卡因伤口导管输注或安慰剂的婴儿术后吗啡累积使用量无显著差异，尽管R组需要使用吗啡的人数较少。伤口导管输注提供了充分的镇痛效果，且无局部麻醉药毒性迹象。由于研究提前终止，该研究可能效能不足。
本研究在欧洲临床试验数据库（EudraCT，2015 - 002209 - 12）注册，并于2016年11月23日在荷兰试验注册中心（NTR6130，国际临床试验注册平台NL - OMON20504）注册。
