CClinicalTrials.gg
Sign In
CompletedNCT06171295LevonUpdated Dec 14, 2023

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

An interventional study of Blood draw in Analgesia, sponsored by University Hospital, Motol. Completed at 1 site in Czechia. Open to participants aged 1 Hour to 5 Weeks. Per ClinicalTrials.gov, last updated 2023-12-14.

Sponsored by University Hospital, Motol · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Feb 2021, registered Nov 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
1 Hour to 5 Weeks
Sex
All
01

Study 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?

02

Conditions studied

  • Analgesia

Browse trials for

Keywords

  • C-CELA
  • newborn
  • analgesia
  • epidural
  • pain
03

In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's enrollment of 24 is below the median of 78 across 1,024 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

University Hospital, Motol is the lead sponsor of 45 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour to 5 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Other
    PK of Levobupivacain

    Newborns who received epidural anesthesia with Levobupivacain

    Diagnostic Test: Blood draw

Interventions

  • Diagnostic testBlood draw

    The blood draws in specified time points

06

What researchers measure

Primary outcomes

  1. Safety

    AE, SAE monitoring, opioid intake monitoring

    Time frame: 144 hours

  2. Effectivity

    Pain managment monitoring - Comfort Neo Scale

    Time frame: 144 hours

Secondary outcomes

  1. Neurotoxicity

    Follow up visits with basic neurology examination

    Time frame: up to 5 years

07

Study locations

1 site
  • University hospital Motol
    Prague, 15006, Czechia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06171295
Lead sponsor
University Hospital, Motol
Responsible party
Eva Al Jamal (Head of clinical trial department, University Hospital, Motol) — Principal investigator
First posted
Dec 14, 2023
Start date
Feb 4, 2021
Primary completion
Jul 7, 2022
Completion
Jul 7, 2022
Last update
Dec 14, 2023

Study contacts

Jan Šípek
study chair · University Hospital, Motol

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Agnosia→

Other studies from this sponsor

University Hospital, Motol

Start the discussion