Perioperative Analgesia in Neonates Who Underwent Primary Cleft Lip Repair Surgery

NCT06067854 | Completed

• 1 other identifier: KDAR 9/2023
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Analgesia in Neonates

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours after surgery

Secondary Outcomes (2)

• Oral intake

  24 hours after surgery

• Complications

  24 hours after surgery

Study Arms (2)

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

Interventions

the standard procedure - without regional anaesthesia PROCEDURE

the standard procedure - without regional anaesthesia

infraorbital peripheral blockade with or without nasal peripheral blockade according to the preference of the anesthesiologist and surgeon PROCEDURE

infraorbital peripheral blockade with or without nasal peripheral blockade according to the preference of the anesthesiologist and surgeon

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates with cleft lips who underwent primary cleft lip repair surgery in tertiary center paediatric anesthesiology department

You may qualify if:

• 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)

You may not qualify if:

• ● 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

Sponsors & Collaborators

• Brno University Hospital: lead
• Masaryk University: collaborator

Study Sites (1)

Brno University Hospital

Brno, South Moravian, 62500, Czechia

Location

Related Publications (1)

• 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.

  PMID: 38718430 DERIVED

MeSH Terms

Interventions

Anesthesia, Conduction; Surgeons

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Physicians; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Petr Stourac, prof. MD., Ph.D., MBA

  Department of paediatric anaesthesia and intensive care medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 5, 2023
• Study Start: January 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: January 1, 2022
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

CZ (1)