Evaluation of the efficacy of buprenorphine injection around the stellate ganglion in pain syndromes of the upper body-half
| ISRCTN | ISRCTN59287260 |
|---|---|
| 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
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 |
|---|---|
| andreasgoebel@rocketmail.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| 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(s) | Not provided at time of registration |
| Condition | 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 |
| Overall study end date | 15/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 60 |
| Participant inclusion criteria | Not provided at time of registration |
| 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
- 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 |
|---|
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/04/2008 | Yes | No |
