Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT05778903
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Months
Maximum Age:
24 Months
Study:
NCT05778903
Study Brief:
Protocol Section:
NCT05778903