Perioperative Analgesia in NeonatesNCT06067854
Perioperative Analgesia in Neonates Who Underwent Primary Cleft Lip Repair Surgery
An observational study of Perioperative Analgesia in Neonates, run by Brno University Hospital at 1 site in Czechia.
Trial summary
In retrospective data search the investigators will identified the cumulative consumption of opioid analgesics during surgery and 24 hours after surgery in neonate with cleft lips who underwent primary cleft lip repair surgery. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Perioperative Analgesia in Neonates
- What is being tested?
- the standard procedure - without regional anaesthesia and infraorbital peripheral blockade with or without nasal peripheral blockade according to the preference of the anesthesiologist and surgeon
- Type of treatment
- Surgery or procedure
- How many people
- 111 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2018to 1 Jan 2022
- Phase
- Observational
- 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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates with cleft lips who underwent primary cleft lip repair surgery in tertiary center paediatric anesthesiology department
Who may be able to join
- neonates with unilateral or bilateral cleft lip (U/BCL), all neonates with unilateral or bilateral cleft lip and alveolus (U/BCLA) or with unilateral or bilateral cleft lip, alveolus and palate (total cleft; U/BCLAP) who underwent cleft lip repair surgery in the neonatal period
- the study period (1/2018-12/2021)
Who cannot join
- ● presence of coagulopathy
- thrombocytopenia or thrombopathy
- patients at risk of malignant hyperthermia
- patients who were not neonates (older than 28 days)
- patients who required postoperative mechanical ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Analgesia in Neonates Who Underwent Primary Cleft Lip Repair Surgery: Retrospective Study
In retrospective data search the investigators will identified the cumulative consumption of opioid analgesics during surgery and 24 hours after surgery in neonate with cleft lips who underwent primary cleft lip repair surgery.
Read the detailed description
The cumulative consumption of opioids during surgery and 24 hours after surgery in neonates with cleft lips who underwent primary cleft lip repair surgery is not known. Patients were divided into two groups according to the time period when they underwent surgery. Group 1 were neonates who underwent primary cleft lip repair surgery under general anaesthesia without regional anaesthesia - the time period before regional anesthesia is introduced into the standard procedure. Group 2 are newborns who underwent primary cleft lip repair surgery under general anaesthesia with regional anaesthesia. Group 1 underwent surgery in time period before regional anesthesia was introduced into the standard procedure. In this retrospective study, the anesthesiology perioperative data from January 2018 till December 2021 in the tertiary center of Pediatric anaesthesia will be evaluated.
- Conditions
- Perioperative Analgesia in Neonates
- Being tested
- the standard procedure - without regional anaesthesia, infraorbital peripheral blockade with or without nasal peripheral blockade according to the preference of the anesthesiologist and surgeon
- Keywords
- perioperative analgesia, primary cleft lip repair surgery, infraorbital peripheral blockade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the standard procedure - without regional anaesthesiaProcedure or surgery
the standard procedure - without regional anaesthesia
infraorbital peripheral blockade with or without nasal peripheral blockade according to the preference of the anesthesiologist and surgeonProcedure or surgery
infraorbital peripheral blockade with or without nasal peripheral blockade according to the preference of the anesthesiologist and surgeon
| Study group | Role | What they receive |
|---|---|---|
| Neonates under general anaesthesia without regional anaesthesia | the standard procedure - without regional anaesthesia | |
| Neonates under general anaesthesia with regional anaesthesia | infraorbital peripheral blockade with or without nasal peripheral blockade according to the preference of the anesthesiologist and surgeon |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative consumption of opioids during surgery and 24 hours after surgery
The cumulative consumption of opioid analgesics during surgery and 24 hours after surgery in neonates with regional block compared to neonates without regional anesthesia
Measured: 24 hours after surgery
Secondary outcomes (2)
Oral intake
Difference in time of first oral intake after surgery in the group with regional anesthesia compared to with the group without regional anaesthesia
Measured: 24 hours after surgery
Complications
Complications of regional anesthesia including suction disorders in the group with regional anaesthesia
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Jan 2018
- Primary completion31 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative Analgesia in NeonatesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Stourac, prof. MD., Ph.D., MBA, Study chair, Department of paediatric anaesthesia and intensive care medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067854
- Sponsor's protocol ID
- KDAR 9/2023
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Richtrova M, Koskova O, Janku M, Bonischova T, Fabian D, Stourac P. Regional anesthesia in neonates with cleft lip and palate: Retrospective study. Int J Pediatr Otorhinolaryngol. 2024 May;180:111965. doi: 10.1016/j.ijporl.2024.111965. Epub 2024 May 4.
PubMed 38718430
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Analgesia in Neonates Who Underwent Primary Cleft Lip Repair Surgery: Retrospective Study
- ClinicalTrials.gov ID
- NCT06067854
- Acronym / sponsor ID
- KDAR 9/2023
- Conditions
- Perioperative Analgesia in Neonates
- Keywords
- perioperative analgesia, primary cleft lip repair surgery, infraorbital peripheral blockade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 5 Oct 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.
In retrospective data search the investigators will identified the cumulative consumption of opioid analgesics during surgery and 24 hours after surgery in neonate with cleft lips who underwent primary cleft lip repair surgery.
Detailed description
The cumulative consumption of opioids during surgery and 24 hours after surgery in neonates with cleft lips who underwent primary cleft lip repair surgery is not known. Patients were divided into two groups according to the time period when they underwent surgery. Group 1 were neonates who underwent primary cleft lip repair surgery under general anaesthesia without regional anaesthesia - the time period before regional anesthesia is introduced into the standard procedure. Group 2 are newborns who underwent primary cleft lip repair surgery under general anaesthesia with regional anaesthesia. Group 1 underwent surgery in time period before regional anesthesia was introduced into the standard procedure. In this retrospective study, the anesthesiology perioperative data from January 2018 till December 2021 in the tertiary center of Pediatric anaesthesia will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neonates under general anaesthesia without regional anaesthesia | – | –the standard procedure - without regional anaesthesia |
| Neonates under general anaesthesia with regional anaesthesia | – | –infraorbital peripheral blockade with or without nasal peripheral blockade according to the preference of the anesthesiologist and surgeon |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates with cleft lips who underwent primary cleft lip repair surgery in tertiary center paediatric anesthesiology department
Key inclusion criteria (2 listed)
- neonates with unilateral or bilateral cleft lip (U/BCL), all neonates with unilateral or bilateral cleft lip and alveolus (U/BCLA) or with unilateral or bilateral cleft lip, alveolus and palate (total cleft; U/BCLAP) who underwent cleft lip repair surgery in the neonatal period
- the study period (1/2018-12/2021)
Key exclusion criteria (5 listed)
- ● presence of coagulopathy
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 |
|---|---|---|
| the standard procedure - without regional anaesthesiathe standard procedure - without regional anaesthesia | Procedure or surgery | – |
| infraorbital peripheral blockade with or without nasal peripheral blockade according to the preference of the anesthesiologist and surgeoninfraorbital peripheral blockade with or without nasal peripheral blockade according to the preference of the anesthesiologist and surgeon | Procedure or surgery | – |
Primary outcome
The cumulative consumption of opioids during surgery and 24 hours after surgery
Time frame: 24 hours after surgery
The cumulative consumption of opioid analgesics during surgery and 24 hours after surgery in neonates with regional block compared to neonates without regional anesthesia
2 secondary outcomes
Oral intake
Time frame: 24 hours after surgery
Complications
Time frame: 24 hours after surgery
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 8 Sep 2025.
- Derived from this study: PubMed 38718430Richtrova M, Koskova O, Janku M, Bonischova T, Fabian D, Stourac P. Regional anesthesia in neonates with cleft lip and palate: Retrospective study. Int J Pediatr Otorhinolaryngol. 2024 May;180:111965. doi: 10.1016/j.ijporl.2024.111965. Epub 2024 May 4.
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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.
Petr Stourac, prof. MD., Ph.D., MBA study chair
Department of paediatric anaesthesia and intensive care medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Analgesia in Neonates, run by Brno University Hospital 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 2 inclusion and 5 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 8 Sep 2025. 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?
The cumulative consumption of opioids during surgery and 24 hours after surgery (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06067854, which also lists 1 linked publication.
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 8 Sep 2025.