Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000058471
Ethics application status
Approved
Date submitted
7/01/2016
Date registered
20/01/2016
Date last updated
27/10/2021
Date data sharing statement initially provided
11/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Serum lidocaine levels following administration of topical lidocaine during in office laryngopharyngeal procedures
Scientific title
Serum lidocaine levels following administration of topical lidocaine during in office laryngopharyngeal procedures
Secondary ID [1] 288256 0
none
Universal Trial Number (UTN)
U1111-1178-2040
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anaesthesia 297199 0
lidocaine toxicity 297200 0
Condition category
Condition code
Anaesthesiology 297411 297411 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Sampling blood for estimation of lidocaine levels after topical administration of lidocaine during awake laryngopharyngeal procedures (sampled prior to, 5,10,20, 30 and 60 minutes following administration). Currently the reported range of administered lidocaine is from 220mg to 1200mg. At our institution the average administered dose topically is 340mg.
Intervention code [1] 293546 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296966 0
Serum lidocaine levels
Timepoint [1] 296966 0
Prior to procedure then at 5,10, 20,30, 60 minutes post-administration of lidocaine.
Primary outcome [2] 296967 0
Lidocaine toxicity events are identified by monitoring heart rate, blood pressure and oximetry for the 90 minutes following the administration of lidocaine. Also self report of the subjects for feelings of nausea, lightheadedness, visual disturbance or other notable adverse effects.
Timepoint [2] 296967 0
within 24 hours following procedures
Secondary outcome [1] 319782 0
Cardiac instability. This is monitored with pulse oximetry, heart rate and blood pressure for the 90 minutes following the administration of lidocaine
Timepoint [1] 319782 0
within 90 minutes following procedures and lidocaine administration

Eligibility
Key inclusion criteria
Patients undergoing awake laryngopharyngeal procedures in the office requiring topical anaesthesia
Age >18 years
Ability to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age <18 yrs
Preexisting increased risk of bleeding or thrombosis
Coagulation disorders
Renal disease
Hepatic disease
Pre-exisiting cardiac conduction abnormality
Inability to provide informed consent
Allergy to lidocaine

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Parametric analysis of serum lidocaine concentrations in relation to administered topical dose
Linear regression analysis of factors influencing serum lidocaine levels
Power calculation was performed that assumed a difference of 4mcg/ml between the true mean and the reference mean with a standard deviation of 5mcg/ml and requiring 80% power and 0.05 p value. This suggested that sample group of 18-24 subjects would detect the true differences in means. We felt that to account for drop out and contaminated samples (all blood samples need to be flown to Christchurch for analysis) additional subjects would be required and give robustness to the project, hence the 50 subject recruitment.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/02/2017
Actual
19/11/2018
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
50
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 7500 0
New Zealand
State/province [1] 7500 0
Auckland

Funding & Sponsors
Funding source category [1] 292641 0
Hospital
Name [1] 292641 0
Auckland District Health Board
Country [1] 292641 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland District Health Board
Address
2 Park Rd
Grafton
Auckland 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 291357 0
None
Name [1] 291357 0
none
Address [1] 291357 0
none
Country [1] 291357 0
Other collaborator category [1] 278759 0
Hospital
Name [1] 278759 0
Waitemata District Health Board
Address [1] 278759 0
Shakespeare Rd
Takapuna
Auckland 0740
Country [1] 278759 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294117 0
Northern X Ethics Committee
Ethics committee address [1] 294117 0
Auckland
New Zealand
Ethics committee country [1] 294117 0
New Zealand
Date submitted for ethics approval [1] 294117 0
01/02/2016
Approval date [1] 294117 0
10/03/2016
Ethics approval number [1] 294117 0
16/NTB/44

Summary
Brief summary
In office laryngeal procedures are well tolerated by most patients provided adequate local anaesthesia is achieved. For most laryngologists topical lidocaine is the agent of choice and is considered safe when used in low doses. However the effects of lidocaine toxicity are well known. This study will evaluate and measure the exact serum levels of lidocaine achieved by topical application of lidocaine for in-office procedures in 50 consecutive patients. Analysis will compare real measured levels to reported safe serum levels and correlate this with side effects if present.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43026 0
Dr Jacqueline Allen
Address 43026 0
Auckland Voice and Swallow
PO Box 99743
Newmarket
Auckland 1149
Country 43026 0
New Zealand
Phone 43026 0
+6421897444
Fax 43026 0
+6495222224
Email 43026 0
[email protected]
Contact person for public queries
Name 43027 0
Jacqueline Allen
Address 43027 0
Auckland Voice and Swallow
PO Box 99743
Newmarket
Auckland 1149
Country 43027 0
New Zealand
Phone 43027 0
+6421897444
Fax 43027 0
+6495222224
Email 43027 0
[email protected]
Contact person for scientific queries
Name 43028 0
Jacqueline Allen
Address 43028 0
Auckland Voice and Swallow
PO Box 99743
Newmarket
Auckland 1149
Country 43028 0
New Zealand
Phone 43028 0
+6421897444
Fax 43028 0
Email 43028 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
all data will be pooled and anonymised.


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.