Anesthesia, Local
Conditions
Brief summary
Rationale: Effective and fast topical anesthesia of the nasal mucosa is of paramount importance for nasal instrumentation like nasal fiberoptic procedures, awake nasal fiberoptic intubation and placement of nasogastric tubes. Conventional topical anesthesia for the nasal mucosa is often patchy and not always effective. The investigators hypothesize that topical anesthesia of the nasal mucosa with the nasal atomizer adapter (NAA) provides good to excellent nasal topical anesthesia with high patient comfort. Objective: In this study the NAA will be used for nasal topical anesthesia. The investigators will evaluate complete anesthesia of the nasal mucosa for nasal instrumentation, the use of the NAA and the comfort level for the subjects. Study design: Interventional study. Study population: 20 healthy human volunteers, ASA 1, 18-60 years old. Intervention: Lidocaine 2% will be applied intranasally with the NAA before nasal instrumentation. On completion of the procedure the participant and the researcher will be asked to complete a feedback form. Main study parameters/endpoints: Studying the level of anesthesia of the nasal mucosa as evaluated and demonstrated with successful awake nasal instrumentation with minimal discomfort for the subject. Nature and extent of the burden and risks associated with participation: Risk management on the nasal atomizer adapter (NAA) shows that all user risks are mitigated and no residual risks remain for the use of the device. Testing of the device and the application of the device in daily practice has no additional risks than the present technique of performing topical anaesthesia of the nasal mucosa.
Interventions
DEVICENAA for topical anaesthesia of the nasal cavity
NAA for topical anaesthesia of the nasal cavity
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Participants are not randomized. A randomization (paper) strategy will be applied to determine which drug will be applied in which nostril
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 18-60 years * Lean body weight \>= 50 kg * ASA physical status 1
Exclusion criteria
* Inability to cooperate * History of hepatic, renal and coagulation diseases, * Respiratory tract pathology * Obstruction of the nasal passage * Chronic rhinitis * Chronic sinusitis * Pregnancy * Allergy to amide type of local anaesthetics * No written informed consent by subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of anesthesia | on day of intervention | Studying the level of anesthesia of the nasal mucosa as evaluated and demonstrated with successful awake nasal instrumentation with minimal discomfort for the subject. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of the NAA | on day of intervention | The convenience of using the NAA, reported by using a questionnaire. |
| Comfort level of NAA | on day of intervention | Studying the level of comfort of NAA for the patient, reported by using a questionnaire. |
Countries
Netherlands
Outcome results
None listed