Condition category
Nervous System Diseases
Date applied
13/10/2006
Date assigned
18/04/2007
Last edited
28/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.nhstayside.scot.nhs.uk/

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

Publication citations

Additional files

Editorial Notes