Evaluation of the efficacy of buprenorphine injection around the stellate ganglion in pain syndromes of the upper body-half
ISRCTN | ISRCTN59287260 |
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DOI | https://doi.org/10.1186/ISRCTN59287260 |
Secondary identifying numbers | N0176115639 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 15/04/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andreas Goebel
Scientific
Scientific
c/o Pain Relief Unit
The Churchill
Headington
Oxford
OX3 7LJ
United Kingdom
Phone | +44 (0)1865 226161 |
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andreasgoebel@rocketmail.com |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Pain |
Intervention | Two interventions: 1. Normal injection into buttocks 2. Injection into neck |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | 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 study start date | 01/10/2002 |
Completion date | 15/11/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 60 |
Key inclusion criteria | Not provided at time of registration |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/10/2002 |
Date of final enrolment | 15/11/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
c/o 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 |
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Funders
Funder type
Government
Oxford Radcliffe Hospitals NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | Results | 01/04/2008 | Yes | No |