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
Protocol serial number	06/S1402/98
Sponsor	NHS Tayside (UK)
Funder	Not provided at time of registration.

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

University Department of Anaesthesia
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Phone	+44 (0)1382 632427
Email	g.a.mcleod@dundee.ac.uk

Study information

Primary study design	Interventional
Study design	A randomised, double blind placebo controlled trial.
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Levobupivacaine and clonidine
Primary outcome measure(s)	Incidence of phantom limb pain
Key secondary outcome measure(s)	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
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 sample size at registration	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

United Kingdom
Scotland

Study participating centre

University Department of Anaesthesia

Dundee
DD1 9SY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan