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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 主要终点
- Length of hospital stay
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 3 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •not fulfilling inclusion cirteria
结局指标
主要结局
Length of hospital stay
时间窗: Through out the study completion, an average of approximately 5 days.
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).
次要结局
- Need for supplemental analgesia(During postoperative hospital stay.)
- Pain scores assessed with validated scale FLACC and VAS(From baseline start of study to after 24 hours.)
- Total postoperative opioid consumption(Through out the study completion, an average of approximately 5 days.)
- Incidence of opioid-related side effects(Through out the study completion, an average of approximately 5 days.)
研究者
Jacob Karlsson
Associate Professor
Karolinska University Hospital