A randomised, placebo controlled trial of levobupivacaine or the combination of levobupivacaine and clonidine when administered as a sciatic perineural infusion for the prevention of phantom limb pain after lower limb amputation
ISRCTN | ISRCTN31319378 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN31319378 |
Secondary identifying numbers | 06/S1402/98 |
- Submission date
- 13/10/2006
- Registration date
- 18/04/2007
- Last edited
- 28/03/2013
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Graeme McLeod
Scientific
Scientific
University Department of Anaesthesia
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
Phone | +44 (0)1382 632427 |
---|---|
g.a.mcleod@dundee.ac.uk |
Study information
Study design | A randomised, double blind placebo controlled trial. |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Prevention |
Scientific title | |
Study objectives | The objective of the proposed study is to investigate the incidence of phantom limb pain of patients after lower limb amputation when given a seven day sciatic perineural infusion of saline, levobupivacaine 1.25 mg/ml or the combination of levobupivacaine 1.25 mg/ml and clonidine 1 mg/ml. |
Ethics approval(s) | No ethics approval as of 13/10/2006. |
Health condition(s) or problem(s) studied | Phantom limb pain in amputation cases |
Intervention | Trial status changed to 'stopped' as of 28/03/2013 as it never started. Patients will be randomised to one of three groups of a seven day sciatic perineural infusion of: Group A: Perineural saline Group B: Perineural levobupivacaine 1.25 mg/ml Group C: Perineural levobupivacaine 1.25 mg/ml and clonidine 1 mg/ml |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Levobupivacaine and clonidine |
Primary outcome measure | Incidence of phantom limb pain |
Secondary outcome measures | 1. To assess the incidence of stump pain and phantom limb sensation 2. To assess the degree of postoperative pain relief 3. To compare the need for rescue analgesia 4. To measure the side effect profile of both groups 5. To measure functional outcomes such as time to first drinking, eating, mobilisation and micturition 6. To measure time to readiness for discharge and length of hospital stay 7. Quality of life scores such as Short Form health survey (SF 36), Client Satisfaction Questionnaire (CSQ), Global Self Esteem questionnaire (GSE), Hospital Anxiety Depression Scale, Amputation Activity Score, Neuropathic Pain Score, measured at one, three, six and 12 months |
Overall study start date | 01/03/2007 |
Completion date | 01/03/2011 |
Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 180 |
Key inclusion criteria | All patients presenting for elective lower limb amputation will be approached for recruitment to this study. |
Key exclusion criteria | 1. Signs of cardiac failure (third heart sound, lung crepitations) 2. Presence of seizures, dementia, or encephalopathy 3. Patients with any terminal illness with a life expectancy less than three months |
Date of first enrolment | 01/03/2007 |
Date of final enrolment | 01/03/2011 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
University Department of Anaesthesia
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Sponsor information
NHS Tayside (UK)
Government
Government
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
Phone | +44 (0)1382 660111 |
---|---|
g.a.mcleod@dundee.ac.uk | |
Website | http://www.nhstayside.scot.nhs.uk/ |
https://ror.org/000ywep40 |
Funders
Funder type
Not defined
Not provided at time of registration.
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 |