Perioperative Analgesia in Neonates Who Underwent Primary Cleft Lip Repair Surgery

Active, not recruiting

• Conditions: Perioperative Analgesia in Neonates
• Interventions: 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

• Registration Number: NCT06067854
• Lead Sponsor: Brno University Hospital

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.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2023-09
• Primary Completion: 2023-09-22
• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-09-28
• Last Update Submitted: 2023-09-28
• Study First Posted: 2023-10-05
• Last Update Posted: 2023-10-05
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neonates under general anaesthesia without regional anaesthesia	the standard procedure - 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	infraorbital peripheral blockade with or without nasal peripheral blockade according to the preference of the anesthesiologist and surgeon

Primary Outcome Measures

Name	Time	Method
The cumulative consumption of opioids during surgery and 24 hours after surgery	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 Outcome Measures

Name	Time	Method
Complications	24 hours after surgery	Complications of regional anesthesia including suction disorders in the group with regional anaesthesia
Oral intake	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

Trial Locations

Locations (1)

Brno University Hospital; 🇨🇿 Brno, South Moravian Region, Czechia