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

• Conditions: Each centre will include 30 full term infants, less than 1 month of age and scheduled for major abdominal or thoracic surgery.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-004701-32-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-31
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Following Regional Ethics Committee approval each centre includes 30 newborn infants (< 1 month of age and full term) scheduled for major abdominal or thoracic surgery (ASAI and ASA II).
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified