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

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?

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Diagnostic test: Blood draw

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 15006
    • University Hospital Motol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PK of Levobupivacain; Newborns who received epidural anesthesia with Levobupivacain	Diagnostic test: Blood draw; The blood draws in specified time points

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	AE, SAE monitoring, opioid intake monitoring	144 hours
Effectivity	Pain managment monitoring - Comfort Neo Scale	144 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurotoxicity	Follow up visits with basic neurology examination	up to 5 years

Collaborators and Investigators

• Sponsor: University Hospital, Motol
• Investigators: Study Chair: Jan Šípek, University Hospital, Motol

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2021
• Primary Completion (Actual): July 7, 2022
• Study Completion (Actual): July 7, 2022

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: pain; analgesia; epidural; newborn; C-CELA
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: Levon 1111111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No