A randomised double-blind placebo controlled study of adenosine given as a Bier's block for patients with neuropathic pain in the limbs

ISRCTN	ISRCTN86618747
DOI	https://doi.org/10.1186/ISRCTN86618747
Protocol serial number	N0176113615
Sponsor	Department of Health (UK)
Funder	Oxford Radcliffe 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 Dominic Aldington
Scientific

Pain Relief Unit
The Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom

Phone	+44 01865 226193
Email	daldington@mac.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Adenosine is used as an analgesic in certain circumstances and it is possible that given as a Bier's block it will relieve pain. Previous unpublished neurophysiological studies in healthy volunteers have shown that it relieves pain of the tourniquet. It is planned to investigate the effect of adenosine as a Bier's block on peripheral neuopathic pain and also to confirm or deny this effect on tourniquet pain.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Signs and Symptoms: Pain
Intervention	Adenosine vs placebo Added 18 July 2008: trial stopped
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	adenosine
Primary outcome measure(s)	1. Pain intensities and relief, both before and for 1 month after each injection. In addition all side effects will be documented and at the end of the study patient satisfaction with each injection. 2. Pain intensity from the tourniquet during each injection
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2002
Reason abandoned (if study stopped)	Insufficient data

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	30
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	10/05/2002
Date of final enrolment	31/12/2002

Pain Relief Unit

Oxford
OX3 7LJ
United Kingdom

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