Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000237189p
Ethics application status
Submitted, not yet approved
Date submitted
13/01/2019
Date registered
18/02/2019
Date last updated
11/04/2019
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Superior laryngeal nerve block for laryngeal sensory neuropathy
Scientific title
Superior laryngeal nerve block for the treatment of chronic cough and vocal cord dysfunction (laryngeal sensory neuropathy)
Secondary ID [1] 297052 0
Nil known
Universal Trial Number (UTN)
U1111-1226-6660
Trial acronym
SLN block
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laryngeal sensory neuropathy 311047 0
Chronic Cough 311048 0
Vocal cord dysfunction 311049 0
Condition category
Condition code
Respiratory 309687 309687 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 313328 0
Treatment: Drugs
Comparator / control treatment
Normal saline
Control group
Placebo

Outcomes
Primary outcome [1] 318656 0
Change in symptom scores on vocal cord dysfunction questionnaire
Timepoint [1] 318656 0
3 months
Primary outcome [2] 319001 0
Change in symptom scores on cough severity index
Timepoint [2] 319001 0
3 months
Secondary outcome [1] 365597 0
change in symptom scores on vocal cord dysfunction questionnaire
Timepoint [1] 365597 0
12 months
Secondary outcome [2] 366697 0
change in symptom scores on cough severity index
Timepoint [2] 366697 0
12 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomized using an online sequence generator by a party not involved with recruitment or delivery of treatment. Allocation will occur after recruitment but prior to administering of treatment. Allocation will be provided to the research assistant who will prepare the injectant and blind the participant and injector via masking the syringe with opaque tape.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random permuted blocks within strata
Strata: gender, smoking status, asthma status and predominant symptomatology (cough/VCD)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
nil
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Previous case series examining SLN block in chronic cough reported a mean effect size of 50%. Power was calculated at a more modest 30% effect size, with 80% power and a type 1 error set at 5% for a two tailed hypothesis. Minimum total sample size was calculated at 352 participants

Analysis: SPSSS statistical software will be used to calculate basic descriptive statistics, and further tests of differences between mean outcome scores (t-test, multiple logistic regression analysis)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
352
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12868 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 25343 0
3165 - East Bentleigh

Funding & Sponsors
Funding source category [1] 301622 0
Hospital
Name [1] 301622 0
Department of Otolaryngology, Head and Neck surgery, Monash Health
Country [1] 301622 0
Australia
Primary sponsor type
Hospital
Name
Department of Otolaryngology, Head and Neck surgery, Monash Health
Address
Monash ENT department, 867 Centre Road East Bentleigh, 3165 Victoria
Country
Australia
Secondary sponsor category [1] 301326 0
None
Name [1] 301326 0
Address [1] 301326 0
Country [1] 301326 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302348 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 302348 0
Research Support Services
Level 2, i Block
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 302348 0
Australia
Date submitted for ethics approval [1] 302348 0
16/01/2019
Approval date [1] 302348 0
Ethics approval number [1] 302348 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89910 0
Dr Paul Paddle
Address 89910 0
Monash ENT 867 Centre Rd, East Bentleigh, 3165 Victoria
Country 89910 0
Australia
Phone 89910 0
+61 3 9928 8277
Fax 89910 0
Email 89910 0
paulpaddle@me.com
Contact person for public queries
Name 89911 0
Dr Craig Mooney
Address 89911 0
Monash ENT 867 Centre Rd, East Bentleigh, 3165 Victoria
Country 89911 0
Australia
Phone 89911 0
+61 3 9928 8277
Fax 89911 0
Email 89911 0
craigpmooney@gmail.com
Contact person for scientific queries
Name 89912 0
Dr Craig Mooney
Address 89912 0
Monash ENT 867 Centre Rd, East Bentleigh, 3165 Victoria
Country 89912 0
Australia
Phone 89912 0
+61 3 9928 8277
Fax 89912 0
Email 89912 0
craigpmooney@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.