Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
25/08/2009
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 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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes