Clinical trial NCT06067854: Perioperative Analgesia in Neonates Who Underwent Primary Cleft Lip Repair Surgery
Official title: Perioperative Analgesia in Neonates Who Underwent Primary Cleft Lip Repair Surgery: Retrospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Perioperative Analgesia in Neonates
Keywords: perioperative analgesia
primary cleft lip repair surgery
infraorbital peripheral blockade
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: Masaryk University
First posted: 2023-10-05
Enrollment: 111
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates with cleft lips who underwent primary cleft lip repair surgery in tertiary center paediatric anesthesiology department

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.

Eligibility criteria: 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

Primary outcomes:
measure: The cumulative consumption of opioids during surgery and 24 hours after surgery
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Oral intake
timeFrame: 24 hours after surgery
measure: Complications
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
state: South Moravian Region
Study officials:
affiliation: Department of paediatric anaesthesia and intensive care medicine
name: Petr Stourac, prof. MD., Ph.D., MBA
role: STUDY_CHAIR
References: