Contact information
Type
Scientific
Primary contact
Dr G Rayman
ORCID ID
Contact details
Ipswich Hospital NHS Trust
Heath Road
Ipswich
Suffolk
IP4 5PD
United Kingdom
+44 (0)1473 704 183
gerry.rayman@ipswichhospital.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0254119962
Study information
Scientific title
The use of local anaesthetic (Lignocaine) in fine needle biopsy of thyroid nodules
Acronym
Study hypothesis
To determine whether the use of 2% Lignocaine is beneficial in terms of patient acceptability/comfort and ease of operator technique, when compared with placebo (0.9% saline).
Ethics approval
Ethics approval was received from the local medical ethics committee before trial recruitment began
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Respiratory: Pain
Intervention
Consenting patients will receive either 2% Lignocaine or placebo (0.9% saline). The preparation received will be distributed by a randomised numbered system dictated by the pharmacy department of the Ipswich Hospital. Thus both patient and investigator will be blinded. Between 0.5 and 1.0 ml will be infiltrated with a 30G insulin needle under the skin immediately overlying the thyroid nodule. A period of at least 10 min and less than 20 min will be allowed to be elapsed before performing the biopsy. This will be performed using a standard technique where at least six biopsies will be attempted using a 25G needle. Patients will be asked to rate the level of discomfort experienced on a scale from between 1 and 5. The operator will also be asked to subjectively assess the ease of the procedure and his/her impression of the level of patient discomfort, again this will be rated on a scale from 1-5. The final assessment relates to the success in obtaining adequate specimens for cytological examination.
Intervention type
Drug
Phase
Not Specified
Drug names
Lignocaine
Primary outcome measures
Pain reduction
Secondary outcome measures
Number of aspirations attainable (up to 5) and success in obtaining adequate samples.
Overall trial start date
18/03/2003
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
All patients attending for fine needle aspiration of the thyroid gland to the Ipswich Hospital NHS Trust will be asked to participate.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
60 patients (30 in each group)
Participant exclusion criteria
Patients who have had a previous fine needle aspiration biopsy.
Recruitment start date
18/03/2003
Recruitment end date
31/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Ipswich Hospital NHS Trust
Ipswich, Suffolk
IP4 5PD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ipswich Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary