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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN31319378

Enrollment

180

Registered

2007-04-18

Start date

2007-03-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phantom limb pain in amputation cases Nervous System Diseases Nerve root and plexus disorders

Interventions

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 G

Eligibility

Inclusion criteria

Inclusion criteria: All patients presenting for elective lower limb amputation will be approached for recruitment to this study.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Incidence of phantom limb pain	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026