Perioperative Analgesia in Neonates Who Underwent Primary Cleft Lip Repair Surgery
September 2, 2025 updated by: Petr Štourač, MD, Brno University Hospital
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
111
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Moravian
-
Brno, South Moravian, Czechia, 62500
- Brno University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Neonates with cleft lips who underwent primary cleft lip repair surgery in tertiary center paediatric anesthesiology department
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
● 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Neonates under general anaesthesia without regional anaesthesia
the standard procedure - 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
|
infraorbital peripheral blockade with or without nasal peripheral blockade according to the preference of the anesthesiologist and surgeon
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral intake
Time Frame: 24 hours after surgery
|
Difference in time of first oral intake after surgery in the group with regional anesthesia compared to with the group without regional anaesthesia
|
24 hours after surgery
|
|
Complications
Time Frame: 24 hours after surgery
|
Complications of regional anesthesia including suction disorders in the group with regional anaesthesia
|
24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Petr Stourac, prof. MD., Ph.D., MBA, Department of paediatric anaesthesia and intensive care medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
January 1, 2022
Study Registration Dates
First Submitted
September 28, 2023
First Submitted That Met QC Criteria
September 28, 2023
First Posted (Actual)
October 5, 2023
Study Record Updates
Last Update Posted (Estimated)
September 8, 2025
Last Update Submitted That Met QC Criteria
September 2, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KDAR 9/2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.