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Superior laryngeal nerve block for laryngeal sensory neuropathy

Superior laryngeal nerve block for the treatment of chronic cough and vocal cord dysfunction (laryngeal sensory neuropathy)

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000237189
Acronym
SLN block
Enrollment
352
Registered
2019-02-18
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We hypothesis that chronic cough and vocal cord dysfunction are both manifestations of sensory neuropathy of the larynx. The Superior laryngeal nerve supplies the sensory supply of the larynx above the level of the vocal cords. We hypothesize that injection of the superior laryngeal nerve with a steroid and a local anaesthetic will treat the underlying neuropathy and result in reduced patient symptoms. In this study we aim to assess superior laryngeal nerve block in patients with chronic cough and/or VCD in a randomised double blind controlled study. Potential participants will be screened and treated for common causes of chronic cough. Participants with persistent symptoms will be offered enrollment within the trial and after enrollment will be randomized to receive a local anaesthetic with steroid nerve block or placebo (normal saline). Participant symptoms will be monitored with verified patient symptom questionnaires.

Interventions

Superior laryngeal nerve block with 1mL 0.5% bupivacaine and 1:200 000 Adrenaline and 1mL/40mg triamcinolone acetonide by consultant Laryngologist. Participants will be observed for 30 minutes post procedure. Participant will complete symptom questionnaires at 2 weeks post intervention. Participants with improved scores, transient or sustained, will be offered repeat ipsilateral injection of 1mL 0.5% bupivacaine and 1:200 000 Adrenaline and 1mL/40mg triamcinolone acetonide at 2 weekly intervals

Superior laryngeal nerve block with 1mL 0.5% bupivacaine and 1:200 000 Adrenaline and 1mL/40mg triamcinolone acetonide by consultant Laryngologist. Participants will be observed for 30 minutes post procedure. Participant will complete symptom questionnaires at 2 weeks post intervention. Participants with improved scores, transient or sustained, will be offered repeat ipsilateral injection of 1mL 0.5% bupivacaine and 1:200 000 Adrenaline and 1mL/40mg triamcinolone acetonide at 2 weekly intervals until no further improvement in symptom scores. Participants with unchanged or worse scores will be offered contralateral nerve block injections of 1mL 0.5% bupivacaine and 1:200 000 Adrenaline and 1mL/40mg triamcinolone acetonide with second weekly injections offered for participants with improved symptom scores.

Sponsors

Department of Otolaryngology, Head and Neck surgery, Monash Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

No objective evidence on formal testing and/or failure of adequate treatment to more common causes of treatment: Respiratory Disease: - Negative Testing: CXR or CT Chest, Broncho-provocation or Broncho-dilation testing - No response to an 8 week empirical trial of inhaled corticosteroid Allergic Disease: - Negative Testing: Negative RAST or Skin prick testing for inhaled allergens - No response to an 8 week empirical trial of intranasal and/or oral medications (e.g. Steroid, and/or Anti-histamine) Laryngopharyngeal and Gastro-oesophageal Reflux Disease: - Negative Testing: Negative Oral Salivary pepsin assay, or 24 hour dual probe pH/impedance monitoring. - No response to an 8 week empirical trial of both acid reduction and alginate treatment.

Exclusion criteria

Are on neuromodulator medications (ie. Tricyclic anti-depressants, SSRIs, Gabapentinoids) Are on anti-tussive medications (ie Guafenasin) Cannot tolerate an ‘in-office’ procedure Known allergy or intolerance to bupivacaine and/or triamcinolone acetate

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026