abdominal surgery in infants (for example for atresia of duodenum or jejunum)
Conditions
Interventions
Wound catheter placement and medication
At the end of surgery, following closure of the muscle layers and subcutaneous
tissue, the surgeon will place a multi-hole wound catheter superficial to the
m
infants
ropivacaine
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:;- Informed consent;- Children < 1 year of age;- Minimal post-conceptual age of 35 weeks;- Minimal body weight of 1500 grams;- Abdominal (open) surgery
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:;- Withdrawal of informed consent;- Child with neurological disease, renal or hepatic dysfunction;- Chronic (more than one day) opioid or psychotropic drug (e.g. antiepileptics, benzodiazepines, antidepressants) exposure pre- or postnatal, in neonates (maximum 28 old) presenting for surgery, or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: Morphine sparing effect of WCI The mean cumulative amount of morphine administered over 48 hours postoperatively, in mcg/kg, will be compared in both groups (R group and control group). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: 1. Efficacy of treatment of postoperative pain: To determine if WCI with ropivacaine provides adequate treatment of postoperative pain, COMFORT behaviour scale and NRS Pain are measured, and these pain assessments are used to administer rescue morphine doses IV. Parameters: * Number of patients needing extra morphine boluses (rescue), over 48 hours. * Total amount of morphine administered postoperatively, until removal of the wound catheter. * AUC 24 hours COMFORT-B score and NRS, and percentage of high pain scores (NRS * 4 and COMFORT * 17). 2. Safety of the use of WCI with ropivacaine: To investigate if WCI with local anesthetics is safe for the treatment of postoperative pain in children, the incidence of adverse events related to the wound catheter and the use of ropivacaine is registered Parameters: * Toxicity due to overdose or inadvertent intravascular injection of local anesthetic: - hypotension - arrhythmia - convulsions * The incidence of adverse effects related to the wound catheter: - accidental luxation of the wound catheter - infection (wound infection, sepsis) - hematoma of the wound - delayed healing of the wound - wound dehiscence * Plasma concentrations of ropivacaine (total and unbound) will be measured during the phase of continuous infusion in the wound, to determine if plasma levels do not exceed toxic thresholds. 3. Adverse events related to the use of opioids: * Signs of respiratory depression: - number of apnea episodes - number of intubated and ventilated patients in each group, when admitted to the PICU - time on the ventilator postoperatively - number of reintubated patients during the study period - number of patients receiving naloxone - time until discharge from the PICU (if admitted to the PICU) - time until discharge to the ward (if admitted to the recovery postoperatively) * Gastro-intestinal: - signs of intestinal obstruction and nausea and vomiting - time to first f | — |
Countries
The Netherlands
Outcome results
None listed