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Efficacy and Safety of Wound Catheter Infusion with Ropivacaine After Abdominal Surgery in Children Aged < 1 Year: A
Lonneke M Staals1, Jaap Dogger2, Claudia Keyzer-Dekker3
1Department of Anesthesiology, Erasmus MC Sophia Children's Hospital, University Medical Center Rotterdam, Dr. Molewaterplein 40, PO Box 2060, 3000 CB, Rotterdam, The Netherlands. l.staals@erasmusmc.nl.
Insights
Wound catheter infusion with ropivacaine showed potential for reducing morphine use in infants after surgery. While not statistically significant, fewer infants receiving ropivacaine required rescue analgesia, indicating safe and effective pain management.
Area of Science:
- Pediatric Anesthesiology
- Surgical Pain Management
- Pharmacology
Background:
- Wound catheter infusion (WCI) with local anesthetics is effective for adult postoperative pain.
- Limited data exists on WCI efficacy and safety in infants.
- This study evaluated WCI with ropivacaine for infant postoperative pain.
Purpose of the Study:
- To assess the efficacy of ropivacaine WCI in reducing opioid requirements in infants.
- To evaluate the safety and tolerability of ropivacaine WCI in pediatric patients.
- To compare postoperative pain scores and adverse events between ropivacaine and placebo groups.
Main Methods:
- Prospective, randomized, double-blind, placebo-controlled trial in infants under 1 year undergoing abdominal surgery.
- Ropivacaine WCI (bolus + infusion) versus placebo WCI for 72 hours.
- Primary outcome: cumulative morphine use in the first 48 hours; secondary outcomes: pain scores, adverse events, ropivacaine plasma levels.
Main Results:
- Study discontinued early due to slow recruitment, analyzing 28 infants (14 per group).
- No significant difference in median cumulative morphine use (P=0.068).
- Significantly fewer infants in the ropivacaine group required morphine (6/14 vs 13/14, P=0.013); pain scores and ropivacaine levels were comparable and safe.
Conclusions:
- Wound catheter infusion with ropivacaine did not significantly reduce overall morphine use but decreased the number of infants needing rescue analgesia.
- WCI with ropivacaine appears safe for infants, with no local anesthetic toxicity observed.
- The study was likely underpowered due to early discontinuation, warranting further investigation.
Background And Objective:
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.
Methods:
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.
Results:
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.
Conclusions:
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.
Clinical Trial Registration:
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).
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