Contact information
Type
Scientific
Primary contact
Dr Andrew D Farmery
ORCID ID
Contact details
Nuffield Department of Anaesthetics
Radcliffe Infirmary
Woodstock Road
Oxford
OX2 6HD
United Kingdom
+44 (0)1865 311188
andrew.farmery@nda.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0176120400
Study information
Scientific title
Acronym
Study hypothesis
1. To test the hypothesis that the efficacy of epidurally administered clonidine does not differ from that of epidurally administered placebo.
2. To determine whether the use of epidurally administered clonidine would produce sufficient benefit to our patients to justify altering our practice to include it.
Ethics approval
Approved by Oxford Research Ethics Committee.
Study design
Randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery: Analgesia
Intervention
Epidurally administered clonidine vs epidurally administered placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
clonidine
Primary outcome measures
Pain score, morphine consumption (PCA), nausea, vomiting, blood pressure.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
07/10/2002
Overall trial end date
30/01/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Added June 2008:
Patients scheduled for elective lumbar decompression or discectomy surgery.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
30 patients, 30 controls, total 60.
Participant exclusion criteria
Added June 2008:
1. Patients taking strong opioids preoperatively or with chronic pain states
2. Patients under 18 years of age
Recruitment start date
07/10/2002
Recruitment end date
30/01/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nuffield Department of Anaesthetics
Oxford
OX2 6HD
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
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
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19151300
Publication citations
-
Results
Farmery AD, Wilson-MacDonald J, The analgesic effect of epidural clonidine after spinal surgery: a randomized placebo-controlled trial., Anesth. Analg., 2009, 108, 2, 631-634, doi: 10.1213/ane.0b013e31818e61b8.