Length of Hospital Stay and Postoperative Analgesic Requirements After Introduction of a Specific Maxillary Nerve Block in Children Undergoing Cleft Palate Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cleft Palate Children. Basic parameters: 3 months — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Length of Hospital Stay and Postoperative Analgesic Requirements After Introduction of a Specific Maxillary Nerve Block in Children Undergoing Cleft Palate Surgery: a Before-and-after Chart Review Study
Overview
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.
Detailed description
Scientific background and rationale Cleft lip and palate (CLP) is one of the most common congenital malformations and often requires repeated surgical corrections during childhood. These procedures are associated with considerable postoperative pain that may delay recovery and prolong hospital stay. Traditionally, systemic analgesics (opioids, NSAIDs, and acetaminophen given intravenously or orally) have been used, but these are often insufficient or associated with adverse effects.
Peripheral nerve blocks have become an established and effective method to optimize pain control and reduce side effects in many surgical procedures. The suprazygomatic maxillary nerve block (SZMNB) is a well-described technique that can provide efficient analgesia in cleft palate surgery. Previous studies have demonstrated its safety and analgesic benefits.
Objectives and hypothesis The aim of this study is to evaluate the effectiveness and patient benefits of introducing routine SZMNB as an adjunct to standard analgesic therapy in children undergoing cleft palate surgery at Astrid Lindgren Children's Hospital, Karolinska University Hospital.
Hypothesis: SZMNB provides superior postoperative pain control and shorter hospital stay compared with conventional systemic analgesia alone.
Study design and methods This is a retrospective observational study based on chart review of patients aged 3 months-15 years who underwent cleft palate surgery at Astrid Lindgren Children's Hospital during 2017-2018. No intervention will be performed.
Data will be collected from medical records, including demographics (age, sex, weight), surgical procedure, perioperative and postoperative analgesic regimen (type, dose, timing), presence of SZMNB, pain scores when available, and any recorded adverse effects (nausea, sedation, etc.).
Outcome measures Primary outcome: Length of hospital stay, defined as time from arrival in the recovery unit to the time of discharge documentation.
Secondary outcomes: Total postoperative opioid consumption, need for supplemental analgesia, and frequency of opioid-related side effects (e.g., nausea, sedation).
Statistical analysis Pseudonymized data will be analyzed descriptively and comparatively using standard statistical methods. Results will be presented in tables and figures. Manuscript preparation and analysis will be conducted at Karolinska Institutet, and the results will be submitted for publication in a peer-reviewed journal.
Clinical significance Peripheral nerve blocks such as SZMNB may reduce opioid requirements, shorten hospital stay, and improve recovery in children after cleft palate surgery. This project aims to quantify these effects within our institution. Demonstrated benefits could support wider implementation of SZMNB, improve care efficiency, and enhance the quality of postoperative recovery for affected children.
Primary outcome measures
- Length of hospital stay [Time frame: Through out the study completion, an average of approximately 5 days.]
Secondary outcome measures (4)
- Total postoperative opioid consumption [Time frame: Through out the study completion, an average of approximately 5 days.]
- Need for supplemental analgesia [Time frame: During postoperative hospital stay.]
- Incidence of opioid-related side effects [Time frame: Through out the study completion, an average of approximately 5 days.]
- Pain scores assessed with validated scale FLACC and VAS [Time frame: From baseline start of study to after 24 hours.]
Eligibility criteria
criteria for participating in the study
- 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).
Exclusion Criteria: not fulfilling inclusion cirteria
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Center not named — Stockholm
Identifiers
NCT: NCT07279883 · Dnr 2025-04058-01