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 |
| Secondary identifying numbers | N0176113615 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 20/10/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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 Dominic Aldington
Scientific
Scientific
Pain Relief Unit
The Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom
| Phone | +44 01865 226193 |
|---|---|
| daldington@mac.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 Previous unpublished neurophysiological studies in healthy volunteers have shown that it relieves pain of the tourniquet.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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | adenosine |
| Primary outcome measure | 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 |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 10/05/2002 |
| Completion date | 31/12/2002 |
| Reason abandoned (if study stopped) | Insufficient data |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 30 patients |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Pain Relief Unit
Oxford
OX3 7LJ
United Kingdom
OX3 7LJ
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 |
|---|
Funders
Funder type
Government
Oxford Radcliffe Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
