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ISRCTN
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ISRCTN48936612
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ClinicalTrials.gov identifier
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Public title
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The use of local anaesthetic (Lignocaine) in fine needle biopsy of thyroid nodules
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0254119962
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Study hypothesis
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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).
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Ethics approval
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Ethics approval was received from the local medical ethics committee before trial recruitment began.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Respiratory: Pain
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Participants - inclusion criteria
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All patients attending for fine needle aspiration of the thyroid gland to the Ipswich Hospital NHS Trust will be asked to participate.
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Participants - exclusion criteria
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Patients who have had a previous fine needle aspiration biopsy.
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Anticipated start date
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18/03/2003
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Anticipated end date
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31/12/2007
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet.
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Target number of participants
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60 patients (30 in each group)
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Interventions
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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.
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Primary outcome measure(s)
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Pain reduction
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Secondary outcome measure(s)
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Number of aspirations attainable (up to 5) and success in obtaining adequate samples.
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Sources of funding
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Ipswich Hospital NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
G
Rayman
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Address
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Ipswich Hospital NHS Trust
Heath Road
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City/town
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Ipswich, Suffolk
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Zip/Postcode
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IP4 5PD
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Country
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United Kingdom
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Tel
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+44 (0)1473 704183
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Fax
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+44 (0)1473 704 197
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Email
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gerry.rayman@ipswichhospital.nhs.uk
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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28/05/2008
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Date ISRCTN assigned
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12/09/2003
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