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ISRCTN
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ISRCTN59287260
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ClinicalTrials.gov identifier
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Public title
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Evaluation of the efficacy of buprenorphine injection around the stellate ganglion in pain syndromes of the upper body-half
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0176115639
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Study hypothesis
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1. To determine if 0.025 mg buprenorphine, a highly lipohilic morphine derivate, is more efficient than saline in relieving chronic, non-nociceptive pain when injected in proximity to the stellate ganglion. The stellate ganglia are collections of autonomic nerve cells and synapses located on either side of the neck.
2. A minimally traumatising method for injection of the stellate ganglion, not previously been published in the English literature will be used; this method is applied in German pain clinics. Our objective is to ascertain the usefulness of this method in conjunction with stellate opioid injections.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Pain
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/10/2002
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Anticipated end date
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15/11/2004
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Status of trial
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Completed
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Patient information material
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Target number of participants
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60
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Interventions
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Two interventions:
1. Normal injection into buttocks
2. Injection into neck
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Primary outcome measure(s)
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1. Pain reduction over the first 8 hours following stellate injection, as calculated from the median of four, two-hourly measurements of present pain reduction using a visual analogue scale (VAS) and compared between buprenorphine and placebo stellate injections
2. Absolute pain levels as expressed using a VAS scale and calculated from the median of four, two-hourly measurements of present pain intensity (PPI), each divided by the pre-injection PPI and compared between buprenorphine and placebo stellate injections
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Oxford Radcliffe Hospitals NHS Trust (UK)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/17638583
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Contact name
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Dr
Andreas
Goebel
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Address
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c/o Pain Relief Unit
The Churchill
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 7LJ
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Country
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United Kingdom
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Tel
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+44 (0)1865 226161
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Fax
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+44 (0)1865 226160
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Email
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andreasgoebel@rocketmail.com
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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15/04/2008
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Date ISRCTN assigned
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12/09/2003
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