Perioperative Analgesia in Neonates Who Underwent Primary Cleft Lip Repair Surgery

Study Overview
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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.

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

Conditions
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Perioperative Analgesia in Neonates

Intervention / Treatment
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* 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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonates under general anaesthesia without regional anaesthesia<br>the standard procedure - without regional anaesthesia | Procedure: the standard procedure - without regional anaesthesia<br>* the standard procedure - without regional anaesthesia<br>|
| Neonates under general anaesthesia with regional anaesthesia<br>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<br>* infraorbital peripheral blockade with or without nasal peripheral blockade according to the preference of the anesthesiologist and surgeon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral intake | Difference in time of first oral intake after surgery in the group with regional anesthesia compared to with the group without regional anaesthesia | 24 hours after surgery | 
| Complications | Complications of regional anesthesia including suction disorders in the group with regional anaesthesia | 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perioperative analgesia, primary cleft lip repair surgery, infraorbital peripheral blockade