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
Protocol serial number	N0176115639
Sponsor	Department of Health (UK)
Funder	Oxford Radcliffe Hospitals NHS Trust (UK)

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

c/o Pain Relief Unit
The Churchill
Headington
Oxford
OX3 7LJ
United Kingdom

Phone	+44 (0)1865 226161
Email	andreasgoebel@rocketmail.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Buprenorphine
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	15/11/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

United Kingdom
England

Study participating centre

c/o Pain Relief Unit

Oxford
OX3 7LJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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