Clinical trial NCT02733783: Design of a Model to Study Functionality of the Trigeminal Nerve in Relation to Controlled Nasal Fractures
Official title: Design of a Model to Study Functionality of the Trigeminal Nerve in Relation to Controlled Nasal Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture of Nasal Bones, Sequela
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary aim of the study is to create a model; in order to examine the effects of neural trauma in patients that are healthy individuals, induced by controlled nasal fractures during rhinoplasty, and the regeneration process in the weeks/months that follow. This study includes monitoring of subjective nasal symptoms with a visual analogue scale (VAS) score, peak nasal inspiratory flow (PNIF) measurements, collection of nasal secretions and nasal provocation (response to capsaicin and cold dry air (CDA) exposure).

Detailed description: The investigators will set up a prospective mono-center study. The investigators will utilize objective and subjective parameters in order to assess trigeminal nerve function at the level of the nasal mucosa before and after septorhinoplasty (as a model of controlled nasal fractures). The subjective parameters involve a visual analogue scale (VAS) score for each individual nasal symptom (nasal obstruction, facial pain/pressure, headache, rhinorrhea, sneezing, pruritus, post nasal drip, and loss of smell). An objective assessment includes measurement of PNIF (Peak Nasal Inspiratory Flow), the presence of neuropeptides in nasal secretions, (by introducing merocels and removing them 5 minutes later), short cold dry air (CDA) provocation and capsaicin provocation with subsequent measurements of PNIF and VAS scores and neuropeptides.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing septorhinoplasty, with planned bilateral osteotomies
2. No rhinological symptoms/complaints (rhinorrhea, sneezing, itchiness, nasal obstruction)
3. Age \> 18 and \< 65 years
4. Written informed consent
5. Willingness to adhere to visit schedules
6. Adequate contraceptive precautions in female patients with childbearing potential

Exclusion Criteria:

1. Age \< 18 and \> 65 years
2. Patients with nasal symptoms at baseline, defined as having more than 2,5 on VAS score

   for individual nasal symptoms related to mucosal pathology
3. Nasal endoscopic signs of inflammatory pathology (rhinitis, rhinosinusitis with/without

   nasal polyps)
4. Use of systemic steroid treatment, intranasal steroid treatment, oral leukotriene antagonists

   or long acting antihistamines?
5. Asthma
6. Pregnancy or breastfeeding
7. Any disorder of which might compromise the ability of a patient to give truly informed

   consent for participation in this study.
8. Enrollment in other investigational drug trial(s) or is receiving other investigational

   agent(s) for any other medical condition.
9. Contra-indications for local anaesthesia (Cocaine 5%)
10. Smoking
11. Systemic disease with lesions in ENT domain
12. Malignancies or severe comorbidity

Primary outcomes:
measure: changes from baseline PNIF (peak nasal inspiratory flow) at 2 weeks, 3 and 6 months after rhinoplasty
timeFrame: Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
measure: changes from baseline VAS (visual analogue score) for nasal obstruction at 2 weeks, 3 and 6 months after rhinoplasty
timeFrame: Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
measure: changes from baseline level of neuro mediators in nasal secretions, at 2 weeks, 3 and 6 months after rhinoplasty
timeFrame: Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
measure: changes from baseline VAS (visual analogue score) for rhinorrhea at 2 weeks, 3 and 6 months after rhinoplasty
timeFrame: Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
measure: changes from baseline VAS (visual analogue score) for facial pain at 2 weeks, 3 and 6 months after rhinoplasty
timeFrame: Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
measure: changes from baseline VAS (visual analogue score) for sneezing at 2 weeks, 3 and 6 months after rhinoplasty
timeFrame: Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
measure: changes from baseline VAS (visual analogue score) for pruritus at 2 weeks, 3 and 6 months after rhinoplasty
timeFrame: Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
measure: changes from baseline VAS (visual analogue score) for catarrh at 2 weeks, 3 and 6 months after rhinoplasty
timeFrame: Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
measure: changes from baseline VAS (visual analogue score) for sense of smell at 2 weeks, 3 and 6 months after rhinoplasty
timeFrame: Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
measure: changes from baseline VAS (visual analogue score) for headache at 2 weeks, 3 and 6 months after rhinoplasty
timeFrame: Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
Secondary outcomes:
Other outcomes:
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