The primary aim of study is to determine PK and PD of levobupivacaine in newborns (premature included). And discover or decline of LA cumulation. The secondary aim of the study is to obtain enough information about decrease of opiate doses, occurrence of side effects of c-CELA, occurrence of tolerance, hyperalgesia and withdrawal syndrome associated with opiates.
Conditions
Interventions
Trade Name: CHIROCAINE 5MG/ML
Pharmaceutical Form: Infusion
Sponsors
Fakultní nemocnice v Motole
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects fulfilling following criteria will be enrolled into the study during the 2 years time period. ? Obtained informed consent of parent(s)/legal representative(s) ? Age younger than 45th week of PMA ? 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 ) Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Decline of informed consent by parent(s) legal representative ? Age older than 45th week of PMA ? Congenital malformation of caudal part of spine ( spina bifida oculta , 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) ? Severe anemia, which would lead to blood transfusion due to taking of blood samples
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of study is to determine PK and PD of levobupivacaine in newborns (premature included). And discover or decline of LA cumulation.;Secondary Objective: The secondary aim of the study is to obtain enough information about decrease of opiate doses, occurrence of side effects of c-CELA, occurrence of tolerance, hyperalgesia and withdrawal syndrome associated with opiates. That could be a base for possibly following study or meta-analysis comparing use of c-CELA and opiates and show benefits of c-CELA and clarify its influence on opiate AE incidence and perhaps outcome of critically ill newborns.;Primary end point(s): The primary aim of study is to determine PK and PD of levobupivacaine in newborns (premature included). And discover or decline of LA cumulation.;Timepoint(s) of evaluation of this end point: 30 days follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary aim of the study is to obtain enough information about decrease of opiate doses, occurrence of side effects of c-CELA, occurrence of tolerance, hyperalgesia and withdrawal syndrome associated with opiates. That could be a base for possibly following study or meta-analysis comparing use of c-CELA and opiates and show benefits of c-CELA and clarify its influence on opiate AE incidence and perhaps outcome of critically ill newborns.;Timepoint(s) of evaluation of this end point: 2 and 5 years | — |
Countries
Czech Republic
Contacts
Public ContactMUDr. Jan Šípek
Fakultní nemocnice v Motole
Outcome results
None listed