Perioperative Analgesia in Neonates Who Underwent Primary Cleft Lip Repair Surgery

Brno University Hospital

Status: Completed

Conditions: Perioperative Analgesia in Neonates

Treatments: Procedure: the standard procedure - without regional anaesthesia; Procedure: infraorbital peripheral blockade with or without nasal peripheral blockade according to the preference of the anesthesiologist and surgeon

Study type: Observational

Funder types: Other

Identifiers

NCT06067854

KDAR 9/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

111 participants in 2 patient groups

Neonates under general anaesthesia without regional anaesthesia

Description:

the standard procedure - without regional anaesthesia

Neonates under general anaesthesia with regional anaesthesia

Description:

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