Perioperative Analgesia in Neonates Who Underwent Primary Cleft Lip Repair Surgery

NCT ID: NCT06067854

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-01-01

Brief Summary

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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

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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

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Perioperative Analgesia in Neonates

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Neonates under general anaesthesia without regional anaesthesia

the standard procedure - without regional anaesthesia

No interventions assigned to this group

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

No interventions assigned to this group

Interventions

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the standard procedure - without regional anaesthesia

the standard procedure - without regional anaesthesia

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

0 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Masaryk University

OTHER

Sponsor Role collaborator

Brno University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Petr Štourač, MD

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Petr Stourac, prof. MD., Ph.D., MBA

Role: STUDY_CHAIR

Department of paediatric anaesthesia and intensive care medicine

Locations

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Brno University Hospital

Brno, South Moravian, Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type DERIVED
PMID: 38718430 (View on PubMed)

Other Identifiers

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KDAR 9/2023

Identifier Type: -

Identifier Source: org_study_id

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