Perioperative Analgesia in Neonates Who Underwent Primary Cleft Lip Repair Surgery

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Perioperative Analgesia in Neonates
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• Czechia
  • South Moravian Region
    • Brno, South Moravian Region, Czechia, 62500
      • Brno University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Neonates with cleft lips who underwent primary cleft lip repair surgery in tertiary center paediatric anesthesiology department

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neonates under general anaesthesia without regional anaesthesia; the standard procedure - without regional anaesthesia	Procedure: 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	Procedure: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Collaborators: Masaryk University
• Investigators: Study Chair: Petr Stourac, prof. MD., Ph.D., MBA, Department of paediatric anaesthesia and intensive care medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): September 22, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: perioperative analgesia; primary cleft lip repair surgery; infraorbital peripheral blockade
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: KDAR 9/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No