Wound catheter infusion after abdominal surgery in baby's.

Less opioids after major abdominal surgery in young infants using wound catheter infusion with local anesthetics: a randomized controlled trial. - Wound catheter infusion after abdominal surgery in baby's

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002209-12-NL

Enrollment

Registered

2017-04-12

Start date

2017-06-21

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children < 1 year of age undergoing major open abdominal surgery. MedDRA version: 20.1 Level: PT Classification code 10021298 Term: Ileal atresia System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.1 Level: PT Classification code 10010526 Term: Congenital large intestinal atresia System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.1 Level: PT Classification code 10002120 Term: Anal atresia System Organ Class: 10

Interventions

Trade Name: ropivacaine Product Name: ropivacaine Product Code: ropivacaine Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for infusion Route of administratio

Eligibility

Sex/Gender

All

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 =65 years) no F.1.3.1 Number of subjects for this age range

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 days old) presenting for surgery, or < 1 month ago. - Opioid exposure <24 hours before surgery - Receiving ECMO therapy - Known allergy / intolerance for paracetamol or morphine - Contra-indications for regional analgesia techniques: o Allergy to local anesthetics o Local or general infection (sepsis)

Design outcomes

Primary

Measure	Time frame
Main Objective: In this prospective, double-blind, randomized controlled trial, we investigate the hypothesis that regional anesthesia provided by WCI with ropivacaine will reduce pain postoperatively (as measured with COMFORT behavior scale and Numeric Rating Scale (NRS) Pain scores) and lead to a morphine-sparing effect of at least 30% after major abdominal surgery in infants 4 and COMFORT B scale > 16, which indicates pain.	—

Measure

Time frame

Main Objective: In this prospective, double-blind, randomized controlled trial, we investigate the hypothesis that regional anesthesia provided by WCI with ropivacaine will reduce pain postoperatively (as measured with COMFORT behavior scale and Numeric Rating Scale (NRS) Pain scores) and lead to a morphine-sparing effect of at least 30% after major abdominal surgery in infants 4 and COMFORT B scale > 16, which indicates pain.

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 1. Number of patients needing extra morphine boluses (rescue), over 48 hours. 2. Total amount of morphine administered postoperatively, until removal of the wound catheter (until 72 hours postop) 3. AUC 24 hours COMFORT-B score and NRS, and percentage of high pain scores. 4. The incidence of opioid related adverse effects: until 72 hours postop 5. The incidence of ropivacaine related side effects: until 72 hours postop 6. The incidence of adverse effects related to the wound catheter: until 72 hours postop 7. Plasma concentrations of ropivacaine: maximum six samples over 72 hours 8. Baseline values: at inclusion 9. Time until discharge from the PICU/ recovery ward: at discharge 10. Surgical stress: postoperatively 11. PPPM-SF: One week after the operation;Secondary end point(s): 1. Number of patients needing extra morphine boluses (rescue), over 48 hours. 2. Total amount of morphine administered postoperatively, until removal of the wound catheter. 3. AUC 24 hours COMFORT-B score and NRS, and percentage of high pain scores. 4. The incidence of opioid related adverse effects: - Signs of respiratory depression - Gastro-intestinal - Hemodynamic 5. The incidence of ropivacaine related side effects 6. 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 7. Plasma concentrations of ropivacaine: To determine the PK-PD relationship for paracetamol IV and morphine IV, and to determine if plasma ropivacaine levels do not exceed toxic levels, blood samples will be taken from an indwelling arterial line, or at the same time a regular blood sample is taken by heel prick, concomitant with blood sampling for clinical purposes (in case there is no arterial line). PK and PD data will be fitted using data from all individuals simultaneously usin	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 1. Number of patients needing extra morphine boluses (rescue), over 48 hours. 2. Total amount of morphine administered postoperatively, until removal of the wound catheter (until 72 hours postop) 3. AUC 24 hours COMFORT-B score and NRS, and percentage of high pain scores. 4. The incidence of opioid related adverse effects: until 72 hours postop 5. The incidence of ropivacaine related side effects: until 72 hours postop 6. The incidence of adverse effects related to the wound catheter: until 72 hours postop 7. Plasma concentrations of ropivacaine: maximum six samples over 72 hours 8. Baseline values: at inclusion 9. Time until discharge from the PICU/ recovery ward: at discharge 10. Surgical stress: postoperatively 11. PPPM-SF: One week after the operation;Secondary end point(s): 1. Number of patients needing extra morphine boluses (rescue), over 48 hours. 2. Total amount of morphine administered postoperatively, until removal of the wound catheter. 3. AUC 24 hours COMFORT-B score and NRS, and percentage of high pain scores. 4. The incidence of opioid related adverse effects: - Signs of respiratory depression - Gastro-intestinal - Hemodynamic 5. The incidence of ropivacaine related side effects 6. 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 7. Plasma concentrations of ropivacaine: To determine the PK-PD relationship for paracetamol IV and morphine IV, and to determine if plasma ropivacaine levels do not exceed toxic levels, blood samples will be taken from an indwelling arterial line, or at the same time a regular blood sample is taken by heel prick, concomitant with blood sampling for clinical purposes (in case there is no arterial line). PK and PD data will be fitted using data from all individuals simultaneously usin

—

Countries

Netherlands

Contacts

Public ContactLonneke Staals

Erasmus MC Sophia

l.staals@erasmusmc.nl0031107036020

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026