About this trial
Cleft lip and palate (CLP) is one of the most common congenital malformations and requires repeated surgical correction during childhood. Surgical repair is often associated with significant postoperative pain, traditionally managed with morphine, which carries a risk of undesirable side effects. The suprazygomatic maxillary nerve block (SZMNB) has been shown to provide effective analgesia and may reduce the need for opioids.
Routine use of SZMNB was introduced at the pediatric surgery unit at Karolinska University Hospital in late 2017. A before-and-after evaluation project based on retrospective chart review was initiated in 2018 but was not completed due to the COVID-19 pandemic.
The aim of this project is to investigate whether the introduction of SZMNB has reduced postoperative morphine requirements and opioid-related side effects, and whether this has resulted in shorter hospital stays (earlier discharge) after cleft palate repair.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
children aged 3 months to 15 years.
Underwent cleft palate (LKG) surgery between 2017-2018.
Available and complete medical records including perioperative notes, anesthesia documentation, and discharge summaries.
Received either standard systemic analgesia alone (2017) or standard analgesia plus suprazygomatic maxillary nerve block (SZMNB) (2018).
Disqualifiers
None
Trial population
The study population consists of children aged 3 months to 15 years who underwent cleft palate (LKG) surgery at Astrid Lindgren Children's Hospital, Karolinska University Hospital, during 2017-2018. All patients received general anesthesia with standard perioperative monitoring and multimodal analgesia. In 2018, a suprazygomatic maxillary nerve block (SZMNB) was introduced as a routine adjunct to systemic analgesia. The study includes two cohorts: one before (2017) and one after (2018) the implementation of SZMNB. Data are collected retrospectively from medical records without any additional interventions.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Length of hospital stay
Time (in hours) from arrival at the postoperative recovery unit to the time of documented discharge by nursing staff in the electronic medical record (TakeCare).
Secondary outcomes
Total postoperative opioid consumption
Total amount of morphine (mg/kg) or morphine-equivalent opioids administered intravenously and/or orally during the postoperative hospital stay.
Need for supplemental analgesia
Proportion of patients requiring additional rescue analgesics beyond the standard regimen (e.g., extra opioid or NSAID doses).
Incidence of opioid-related side effects
Occurrence of opioid-related adverse effects such as nausea, vomiting, or reduced level of consciousness, as documented in medical records.
Pain scores assessed with validated scale FLACC and VAS
Postoperative pain score assessed using FLACC and VAS . High number indicates worse outcome
Sponsors and contacts
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Karolinska Institutet
Lead sponsor
Karolinska University Hospital
Sponsor institution