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:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT05198518
Eligibility Criteria:
Inclusion Criteria:
* Scheduled for FESS functional nasal or endoscopic sinus surgery
* Possessing an American Society of Anesthesiologists physical status classification of I or II
* Age ≥ 18
* Possess the capacity to give informed consent
* Able to read, write and understand English or Spanish
* Able to attend follow up visits at postop days 7 and 14 Visit 1 (within 0 - day 14) and post-op Visit 2 (within 10 - 21 days)
* Postop pain VAS ≥ 5 in PACU phase II
Exclusion Criteria:
* Age \< 18
* Does not understand English or Spanish
* Does not meet inclusion criteria
* History of chronic pain
* Experiencing chronic pain requiring opioids at baseline and/or who are under the care of pain management specialists
* Neurologic disorders (including seizure disorders)
* Undergoing planned or unplanned additional procedures at the time of FESS surgery
* In custody of the state
* Prisoners
* Known to be pregnant
* Implanted cranial metallic components or devices including deep brain stimulators or cochlear implants
* Has an implanted or external worn cardiac device including pacemakers, automated implantable cardioverter defibrillator (AICD), or any other cardiac electric devices (including non-implanted devices, e.g. defibrillator vest)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05198518
Study Brief:
Protocol Section:
NCT05198518