A randomised double-blind placebo-controlled trial of the efficacy of amitryptiline in post-thoracotomy chronic pain

ISRCTN ISRCTN21038456
DOI https://doi.org/10.1186/ISRCTN21038456
Secondary identifying numbers N0263115157
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
28/11/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
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 M Nicholls
Scientific

Anaesthetics
Department of Anaesthetics
The Middlesex Hospital
Mortimer Street
London
W1N 8AA
United Kingdom

Study information

Study designRandomised double-blind placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA randomised double-blind placebo-controlled trial of the efficacy of amitryptiline in post-thoracotomy chronic pain
Study objectivesIs amitriptyline useful as prophylaxis against post-thoracotomy pain?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSigns and Symptoms: Pain
Intervention1. Amitriptyline
2. Placebo
Intervention typeDrug
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)Amitriptyline
Primary outcome measure1. Numerical verbal pain score
2. Patient pain index
3. Short McGill questionnaire
Secondary outcome measuresNot provided at time of registration
Overall study start date24/07/2002
Completion date01/10/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants60 patients from the Anaesthetics Department
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment24/07/2002
Date of final enrolment01/10/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Middlesex Hospital
London
W1N 8AA
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

University College London Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan