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Perioperative Analgesia in Neonates Who Underwent Primary Cleft Lip Repair Surgery

Perioperative Analgesia in Neonates Who Underwent Primary Cleft Lip Repair Surgery: Retrospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06067854
Enrollment
111
Registered
2023-10-05
Start date
2018-01-01
Completion date
2022-01-01
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Analgesia in Neonates

Keywords

perioperative analgesia, primary cleft lip repair surgery, infraorbital peripheral blockade

Brief 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.

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.

Interventions

PROCEDUREthe standard procedure - without regional anaesthesia

the standard procedure - without regional anaesthesia

PROCEDUREinfraorbital 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

Sponsors

Masaryk University
CollaboratorOTHER
Brno University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The cumulative consumption of opioids during surgery and 24 hours after surgery24 hours after surgeryThe cumulative consumption of opioid analgesics during surgery and 24 hours after surgery in neonates with regional block compared to neonates without regional anesthesia

Secondary

MeasureTime frameDescription
Oral intake24 hours after surgeryDifference in time of first oral intake after surgery in the group with regional anesthesia compared to with the group without regional anaesthesia
Complications24 hours after surgeryComplications of regional anesthesia including suction disorders in the group with regional anaesthesia

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026