Pharmacokinetics and Pharmacodynamics of Levobupivacaine During Continuous Caudal Epidural Analgesia in Newborns (Levon)

University Hospital, Motol

Status

Completed

Conditions

Analgesia

Treatments

Diagnostic Test: Blood draw

Study type

Interventional

Funder types

Other

Identifiers

NCT06171295

Levon 1111111

Details and patient eligibility

About

The goal of this clinical trial is to learn about the pharmacokinetics of levobupivacaine in newborns during the continus caudal epidural analgesia. This type of analgesia is used for severly ill newborns. There is a need to lower the opioid doses for this population who is undergoing the surgery due to the life threading indication. In some cases it is considered to use the epidural analgesia for the sake of the patient.

The main question is:

Is the commonly used dosing of 0,25% levobupivacaine in dose 0,2-0,3mg/kg/h the ideal dosing for these patients?

Is this type of dosing of epidural analgesia safe and effective for newborns?

Enrollment

24 patients

Sex

All

Ages

1 hour to 5 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

Obtained informed consent of parent(s)/legal representative(s)
Age younger than 45thweek of PMA
Age older than 25thweek of PMA
body weight (BW) more than 500g
Previous or planned operation with great demand on POPM
Other diseases demanding great POPM (even without any need of surgery)
Vital functions of the patient will be stable and there will be no suspicion, that patient current condition might be worsen by insertion of c-CELA (every patient will be discussed with attending physician )

Exclusion criteria

Decline of informed consent by parent(s) legal representative
Age older than 45thweek of PMA
Age younger than 25th week of PMA
body weight (BW) lower than 500g
Congenital malformation of caudal part of spine ( spina bifida occulta , meningocele, meningomyelocele)
Disease or congenital malformation significantly restricting liver functions (Elevation of liver enzymes more than twice above the physiological range of the corresponding PMA)
Disease or congenital malformation significantly restricting kidney functions (Elevation of urea and creatinine enzymes more than twice above the physiological range of the corresponding PMA)
Clinical condition, which doesn't long-term POPM
Meningism
Patients with proven withdrawal syndrome caused by opiate administration
High risk of bleeding during insertion (coagulopathy) or known administrated anticoagulants which might be still active in the time of insertion of c-CELA
Substantial anemia (under 90g/l), which could lead to blood transfusion due to blood drawing
frequent blood tests associated with the treatment of the patient(with blood samples necessary for the purposes of the study together), which would exceed maximum
any hemodynamically unstable condition (for example septic shock)