A randomised placebo-controlled trial of the analgesic efficacy of epidurally administered clonidine following spinal surgery.
| ISRCTN | ISRCTN52323712 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52323712 |
| Secondary identifying numbers | N0176120400 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 25/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andrew D Farmery
Scientific
Scientific
Nuffield Department of Anaesthetics
Radcliffe Infirmary
Woodstock Road
Oxford
OX2 6HD
United Kingdom
| Phone | +44 (0)1865 311188 |
|---|---|
| andrew.farmery@nda.ox.ac.uk |
Study information
| Study design | Randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(s) | Approved by Oxford Research Ethics Committee. |
| Health condition(s) or problem(s) studied | Surgery: Analgesia |
| Intervention | Epidurally administered clonidine vs epidurally administered placebo. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | clonidine |
| Primary outcome measure | Pain score, morphine consumption (PCA), nausea, vomiting, blood pressure. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 07/10/2002 |
| Completion date | 30/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 30 patients, 30 controls, total 60. |
| Key inclusion criteria | Added June 2008: Patients scheduled for elective lumbar decompression or discectomy surgery. |
| Key exclusion criteria | Added June 2008: 1. Patients taking strong opioids preoperatively or with chronic pain states 2. Patients under 18 years of age |
| Date of first enrolment | 07/10/2002 |
| Date of final enrolment | 30/01/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nuffield Department of Anaesthetics
Oxford
OX2 6HD
United Kingdom
OX2 6HD
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
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 | 01/02/2009 | Yes | No |
