AnalgesiaLevonNCT06171295
Pharmacokinetics and Pharmacodynamics of Levobupivacaine During Continuous Caudal Epidural Analgesia in Newborns
A study testing Blood draw in people with Analgesia, run by University Hospital, Motol at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 5 weeks
- Conditions the study is for
- Analgesia
- What is being tested?
- Blood draw
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCzechia
- Study dates
- 4 Feb 2021to 7 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 5 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 )
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Blood draw
- Keywords
- C-CELA, newborn, analgesia, epidural, pain
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawDiagnostic test
The blood draws in specified time points
| Study group | Role | What they receive |
|---|---|---|
| PK of Levobupivacain | Other | Newborns who received epidural anesthesia with Levobupivacain Receives: Diagnostic Test: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
AE, SAE monitoring, opioid intake monitoring
Measured: 144 hours
Effectivity
Pain managment monitoring - Comfort Neo Scale
Measured: 144 hours
Secondary outcomes (1)
Neurotoxicity
Follow up visits with basic neurology examination
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start4 Feb 2021
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- PK study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Al Jamal, University Hospital, Motol
- Investigators
- Jan Šípek, Study chair, University Hospital, Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171295
- Sponsor's protocol ID
- Levon 1111111
- Acronym
- Levon
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Levobupivacaine During Continuous Caudal Epidural Analgesia in Newborns
- ClinicalTrials.gov ID
- NCT06171295
- Acronym / sponsor ID
- Levon / Levon 1111111
- Conditions
- Analgesia
- Keywords
- C-CELA, newborn, analgesia, epidural, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PK study
| Arm | Type | Receives |
|---|---|---|
| PK of Levobupivacain | Other | Diagnostic Test: Blood drawNewborns who received epidural anesthesia with Levobupivacain |
Who may qualify
- Ages
- 1 hour to 5 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawThe blood draws in specified time points | Diagnostic test | PK of Levobupivacain |
Primary outcome
Safety
Time frame: 144 hours
AE, SAE monitoring, opioid intake monitoring
Effectivity
Time frame: 144 hours
Pain managment monitoring - Comfort Neo Scale
1 secondary outcome
Neurotoxicity
Time frame: up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Šípek study chair
University Hospital, Motol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood draw in people with Analgesia, run by University Hospital, Motol at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 144 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.