Length of Hospital Stay and Postoperative Analgesic Requirements After Introduction of a Specific Maxillary Nerve Block in Children Undergoing Cleft Palate Surgery

NCT07279883 | Recruiting

• 1 other identifier: Dnr 2025-04058-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cleft Palate Children

Keywords

Cleft palate; Suprazygomatic maxillary nerve block; Pediatric anesthesia; Regional anesthesia; Nerve block; opiod consumtion

Outcome Measures

Primary Outcomes (1)

• 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).

  Through out the study completion, an average of approximately 5 days.

Secondary Outcomes (4)

• Total postoperative opioid consumption

  Through out the study completion, an average of approximately 5 days.

• Need for supplemental analgesia

  During postoperative hospital stay.

• Incidence of opioid-related side effects

  Through out the study completion, an average of approximately 5 days.

• Pain scores assessed with validated scale FLACC and VAS

  From baseline start of study to after 24 hours.

Study Arms (2)

Pre-implementation group (2017)

Children who received standard systemic analgesia (intravenous and/or oral opioids, acetaminophen, and NSAIDs) without nerve block.

Post-implementation group (2018)

Children who, in addition to standard systemic analgesia, received a suprazygomatic maxillary nerve block (SZMNB) as part of routine perioperative care.

Eligibility Criteria

• Age: 3 Months - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Unknown Facility

Stockholm, SE-171 76, Sweden

RECRUITING

MeSH Terms

Conditions

Cleft Palate

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Märit Lundblad, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob KarlssonM, MD PhD

CONTACT

+460812370000; jacob.karlsson.1@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 12, 2025
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)