A randomised double-blind placebo-controlled trial of the efficacy of amitryptiline in post-thoracotomy chronic pain
ISRCTN | ISRCTN21038456 |
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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
Scientific
Anaesthetics
Department of Anaesthetics
The Middlesex Hospital
Mortimer Street
London
W1N 8AA
United Kingdom
Study information
Study design | Randomised double-blind placebo-controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | A randomised double-blind placebo-controlled trial of the efficacy of amitryptiline in post-thoracotomy chronic pain |
Study objectives | Is amitriptyline useful as prophylaxis against post-thoracotomy pain? |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Signs and Symptoms: Pain |
Intervention | 1. Amitriptyline 2. Placebo |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | |
Drug / device / biological / vaccine name(s) | Amitriptyline |
Primary outcome measure | 1. Numerical verbal pain score 2. Patient pain index 3. Short McGill questionnaire |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 24/07/2002 |
Completion date | 01/10/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 60 patients from the Anaesthetics Department |
Key inclusion criteria | Not provided at time of registration |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 24/07/2002 |
Date of final enrolment | 01/10/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Middlesex Hospital
London
W1N 8AA
United Kingdom
W1N 8AA
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Government
University College London Hospitals NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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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 |