Skip to main content
OpenTrials
Completed

NCT Number: NCT06067854

Perioperative Analgesia in Neonates Who Underwent Primary Cleft Lip Repair Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Brno University Hospital

Brno, South Moravian, 62500, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Complications

    Time frame: 24 hours after surgery

    Complications of regional anesthesia including suction disorders in the group with regional anaesthesia

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Collaborators

  • Masaryk University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Oct 5, 2023
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.