Contact information
Type
Scientific
Primary contact
Dr Graeme McLeod
ORCID ID
Contact details
University Department of Anaesthesia
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 632427
g.a.mcleod@dundee.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
06/S1402/98
Study information
Scientific title
Acronym
Study hypothesis
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
No ethics approval as of 13/10/2006.
Study design
A randomised, double blind placebo controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Levobupivacaine and clonidine
Primary outcome measures
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 trial start date
01/03/2007
Overall trial end date
01/03/2011
Reason abandoned
Lack of funding/sponsorship
Eligibility
Participant inclusion criteria
All patients presenting for elective lower limb amputation will be approached for recruitment to this study.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
180
Participant 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
Recruitment start date
01/03/2007
Recruitment end date
01/03/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Department of Anaesthesia
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
NHS Tayside (UK)
Sponsor details
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 660111
g.a.mcleod@dundee.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration.
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