Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
15/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/17638583

Publication citations

  1. 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.

Additional files

Editorial Notes