The use of local anaesthetic (Lignocaine) in fine needle biopsy of thyroid nodules

ISRCTN	ISRCTN48936612
DOI	https://doi.org/10.1186/ISRCTN48936612
Secondary identifying numbers	N0254119962

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 26/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr G Rayman
Scientific

Ipswich Hospital NHS Trust
Heath Road
Ipswich, Suffolk
IP4 5PD
United Kingdom

Phone	+44 (0)1473 704 183
Email	gerry.rayman@ipswichhospital.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	The use of local anaesthetic (Lignocaine) in fine needle biopsy of thyroid nodules
Study objectives	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(s)	Ethics approval was received from the local medical ethics committee before trial recruitment began
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Lignocaine
Primary outcome measure	Pain reduction
Secondary outcome measures	Number of aspirations attainable (up to 5) and success in obtaining adequate samples.
Overall study start date	18/03/2003
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	60 patients (30 in each group)
Key inclusion criteria	All patients attending for fine needle aspiration of the thyroid gland to the Ipswich Hospital NHS Trust will be asked to participate.
Key exclusion criteria	Patients who have had a previous fine needle aspiration biopsy.
Date of first enrolment	18/03/2003
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Ipswich Hospital NHS Trust

Ipswich, Suffolk
IP4 5PD
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Ipswich Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

26/09/2016: No publications found, verifying study status with principal investigator