Using MRI to study maxillary nerve blocks in children undergoing cleft palate surgery
Maxillary Nerve Blocks in Children - An MRI Study of the Suprazygomatic
NA · Oslo University Hospital · NCT05778903
This study tests if using MRI can help doctors see how well a specific nerve block works to manage pain in young children having cleft palate surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 10 Months to 24 Months |
| Sex | All |
| Sponsor | Oslo University Hospital (other) |
| Locations | 1 site (Oslo) |
| Trial ID | NCT05778903 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of ultrasound-guided suprazygomatic maxillary nerve blocks in pediatric patients undergoing cleft palate surgery. It aims to visualize the spread of local anesthetic using magnetic resonance imaging (MRI) to ensure proper contact with the maxillary nerve. The study will include children aged 10 to 24 months and assess the impact of the nerve block on perioperative pain management. The approach combines advanced imaging techniques with a common anesthetic procedure to enhance patient care.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 10 to 24 months scheduled for cleft palate surgery.
Not a fit: Patients with severe medical conditions, cranial deformation, or allergies to local anesthetics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve pain management techniques in pediatric patients undergoing cleft palate surgery.
How similar studies have performed: While the use of nerve blocks in pediatric anesthesia is established, the specific application of MRI to visualize anesthetic spread in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Paediatric patients scheduled for cleft palate (CP) surgery with SMNB as part of their perioperative pain treatment * American Society of Anesthesiologists physical status 1 - 2 * Age 10 to 24 months * Given informed written consent by legal guardian Exclusion Criteria: * American Society of Anesthesiologists physical status \> 2 * Patients with cranial deformation * Patients with concomitant medical treatments or medical conditions interfering with peripheral nerve block treatment * Patients with concomitant medical treatments or medical conditions interfering with MRI * Patients that are allergic to bupivacaine or other local anaesthetic agents.
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (RECRUITING)
Study contacts
- Principal investigator: Axel Sauter, MD PhD — Oslo University Hospital
- Study coordinator: Axel Sauter, MD PhD
- Email: axsa@online.no
- Phone: 93484022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nerve Block, Cleft Palate, Analgesia