Postoperative pain management after major surgery in neonates. Establishing success rate using epidural analgesia and subcutaneous wound catheter infusion.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004701-32-SE

Enrollment

Registered

2014-10-31

Start date

2015-01-22

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Each centre will include 30 full term infants, less than 1 month of age and scheduled for major abdominal or thoracic surgery.

Interventions

Trade Name: Chirocaine. Levobupivacaine Product Name: Chirocaine Product Code: N01BB10 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: LEVOBUPIVACAINE HYDROCHLORIDE CA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Following Regional Ethics Committee approval each centre includes 30 newborn infants (=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Exclusion criteria: Absence of parental consent. Allergy to local anaestethics. Known or suspected liver-, kidney dysfunction or neurological disorder associated with peripheral nerve damage. Intraperitoneal infection/sepsis. Reoperation within 6 weeks. Infants with another severe coexisting sickness (>ASAII). Take down enterostomy. Protocol violation. Summary of Product Charectersistics (SPC) are specified in “Fass för förskrivare, Chirocaine/levobupivacaine”. (Se bilaga SPC levobupivacaine).

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim with the present prospective, blinded and randomized multicentre study is to establish the effectiveness and safety of EDA vs. WCI after major thoracic or abdominal surgery in neonates. ;Secondary Objective: The study endpoints are to establish the effectiveness and safety of epidural analgesia and subcutaneous wound catheter infusion for postoperative analgesia after major thoracic or abdominal surgery in neonates. Pharmacokinetic data will presented as total and free concentration of levobupivacaine at 24, 48 and 72 hours as well as AAG at zero and 72 hours. Pharmacodynamic data will be presented as scores at 24,48 and 72 hours, total opioid consumption over 72 hours, time to start of enteral feeding, time to extubation. Further, the surgical wound will be inspected daily regarding healing, infection up to day 10 after surgery and at follow up visit. Safety data will be presented as signs (or the absence of signs) of local anesthetic systemic toxicity (LAST).;Primary end point(s): Endpoints The study endpoints are to establish the effectiveness and safety of epidural analgesia and subcutaneous wound catheter infusion for postoperative analgesia after major thoracic or abdominal surgery in neonates. Pharmacokinetic data will presented as total and free concentration of levobupivacaine at 24, 48 and 72 hours as well as AAG at zero and 72 hours. Pharmacodynamic data will be presented as scores at 24,48 and 72 hours, total opioid consumption over 72 hours, time to start of enteral feeding, time to extubation. Further, the surgical wound will be inspected daily regarding healing, infection up to day 10 after surgery and at follow up visit. Safety data will be presented as signs (or the absence of signs) of local anesthetic systemic toxicity (LAST).;Timepoint(s) of evaluation of this end point: Pleas see above.	—

Measure

Time frame

Main Objective: The aim with the present prospective, blinded and randomized multicentre study is to establish the effectiveness and safety of EDA vs. WCI after major thoracic or abdominal surgery in neonates. ;Secondary Objective: The study endpoints are to establish the effectiveness and safety of epidural analgesia and subcutaneous wound catheter infusion for postoperative analgesia after major thoracic or abdominal surgery in neonates. Pharmacokinetic data will presented as total and free concentration of levobupivacaine at 24, 48 and 72 hours as well as AAG at zero and 72 hours. Pharmacodynamic data will be presented as scores at 24,48 and 72 hours, total opioid consumption over 72 hours, time to start of enteral feeding, time to extubation. Further, the surgical wound will be inspected daily regarding healing, infection up to day 10 after surgery and at follow up visit. Safety data will be presented as signs (or the absence of signs) of local anesthetic systemic toxicity (LAST).;Primary end point(s): Endpoints The study endpoints are to establish the effectiveness and safety of epidural analgesia and subcutaneous wound catheter infusion for postoperative analgesia after major thoracic or abdominal surgery in neonates. Pharmacokinetic data will presented as total and free concentration of levobupivacaine at 24, 48 and 72 hours as well as AAG at zero and 72 hours. Pharmacodynamic data will be presented as scores at 24,48 and 72 hours, total opioid consumption over 72 hours, time to start of enteral feeding, time to extubation. Further, the surgical wound will be inspected daily regarding healing, infection up to day 10 after surgery and at follow up visit. Safety data will be presented as signs (or the absence of signs) of local anesthetic systemic toxicity (LAST).;Timepoint(s) of evaluation of this end point: Pleas see above.

—

Secondary

Measure	Time frame
Secondary end point(s): Please see above.;Timepoint(s) of evaluation of this end point: Study ends at 72 hours postoperatively.	—

Countries

Netherlands, South Africa, Sweden

Outcome results

None listed

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