Condition category
Respiratory
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
26/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes

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