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

NCT06171295 | Completed

• 1 other identifier: Levon 1111111
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Analgesia

Keywords

C-CELA; newborn; analgesia; epidural; pain

Outcome Measures

Primary Outcomes (2)

• Safety

  AE, SAE monitoring, opioid intake monitoring

  144 hours

• Effectivity

  Pain managment monitoring - Comfort Neo Scale

  144 hours

Secondary Outcomes (1)

• Neurotoxicity

  up to 5 years

Study Arms (1)

PK of Levobupivacain

OTHER

Newborns who received epidural anesthesia with Levobupivacain

Diagnostic Test: Blood draw

Interventions

Blood draw DIAGNOSTIC_TEST

The blood draws in specified time points

PK of Levobupivacain

Eligibility Criteria

• Age: 1 Hour - 5 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 )

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Motol: lead

Study Sites (1)

University hospital Motol

Prague, 15006, Czechia

Location

MeSH Terms

Conditions

Agnosia; Pain

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jan Šípek

  University Hospital, Motol

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinical trial department

Model Details: PK study

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 14, 2023
• Study Start: February 4, 2021
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)