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

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

Study designA randomised, double blind placebo controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific title
Study objectivesThe 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) studiedPhantom limb pain in amputation cases
InterventionTrial 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Levobupivacaine and clonidine
Primary outcome measureIncidence of phantom limb pain
Secondary outcome measures1. 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 date01/03/2007
Completion date01/03/2011
Reason abandoned (if study stopped)Lack of funding/sponsorship

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants180
Key inclusion criteriaAll patients presenting for elective lower limb amputation will be approached for recruitment to this study.
Key exclusion criteria1. 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 enrolment01/03/2007
Date of final enrolment01/03/2011

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

University Department of Anaesthesia
Dundee
DD1 9SY
United Kingdom

Sponsor information

NHS Tayside (UK)
Government

Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Phone +44 (0)1382 660111
Email g.a.mcleod@dundee.ac.uk
Website http://www.nhstayside.scot.nhs.uk/
ROR logo "ROR" 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan