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 amputatio
Completed
- Conditions
- Phantom limb pain in amputation casesNervous System DiseasesNerve root and plexus disorders
- Registration Number
- ISRCTN31319378
- Lead Sponsor
- HS Tayside (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
Inclusion Criteria
All patients presenting for elective lower limb amputation will be approached for recruitment to this study.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of phantom limb pain
- Secondary Outcome Measures
Name Time Method 1. To assess the incidence of stump pain and phantom limb sensation<br>2. To assess the degree of postoperative pain relief<br>3. To compare the need for rescue analgesia<br>4. To measure the side effect profile of both groups<br>5. To measure functional outcomes such as time to first drinking, eating, mobilisation and micturition<br>6. To measure time to readiness for discharge and length of hospital stay<br>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