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

ISRCTN	ISRCTN48936612
DOI	https://doi.org/10.1186/ISRCTN48936612
Protocol serial number	N0254119962
Sponsor	Department of Health (UK)
Funder	Ipswich Hospital NHS Trust (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Lignocaine
Primary outcome measure(s)	Pain reduction
Key secondary outcome measure(s)	Number of aspirations attainable (up to 5) and success in obtaining adequate samples.
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	60
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

United Kingdom
England

Study participating centre

Ipswich Hospital NHS Trust

Ipswich, Suffolk
IP4 5PD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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