Contact information
Type
Scientific
Primary contact
Dr Andreas Goebel
ORCID ID
Contact details
c/o Pain Relief Unit
The Churchill
Headington
Oxford
OX3 7LJ
United Kingdom
+44 (0)1865 226161
andreasgoebel@rocketmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0176115639
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pain
Intervention
Two interventions:
1. Normal injection into buttocks
2. Injection into neck
Intervention type
Drug
Phase
Not Specified
Drug names
Buprenorphine
Primary outcome measure
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
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2002
Overall trial end date
15/11/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2002
Recruitment end date
15/11/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
c/o Pain Relief Unit
Oxford
OX3 7LJ
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Oxford Radcliffe Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/17638583
Publication citations
-
Results
Goebel A, Lawson A, Allen S, Glynn C, Buprenorphine injection to the stellate ganglion in the treatment of upper body chronic pain syndromes., Eur J Pain, 2008, 12, 3, 266-274, doi: 10.1016/j.ejpain.2007.05.009.