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
Protocol serial number	N0263115157
Sponsor	Department of Health (UK)
Funder	University College London Hospitals NHS Trust (UK)

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

Dr M Nicholls
Scientific

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

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
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
Phase
Drug / device / biological / vaccine name(s)	Amitriptyline
Primary outcome measure(s)	1. Numerical verbal pain score 2. Patient pain index 3. Short McGill questionnaire
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/10/2005

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

The Middlesex Hospital

London
W1N 8AA
United Kingdom

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