Condition category
Signs and Symptoms
Date applied
01/03/2001
Date assigned
01/03/2001
Last edited
14/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alastair F Nimmo

ORCID ID

Contact details

University of Edinburgh Department of Anaesthesia Critical Care and Pain Medicine
Royal Infirmary of Edinburgh
Lauriston Place
Edinburgh
EH3 9YW
United Kingdom
+44 (0)131 536 3652
a.nimmo@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SP3481

Study information

Scientific title

A randomised double blind trial of the effect of pre-emptive epidural ketamine on persistent pain after lower limb amputation

Acronym

Study hypothesis

To assess the effect of pre-emptively modulating sensory input with epidural ketamine (an NMDA antagonist) on post-amputation pain and sensory processing.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Pain

Intervention

All patients will have spinal and epidural anaesthesia with bupivacaine established before amputation and will receive an epidural infusion of bupivacaine for 48 to 72 hours after surgery for post-operative analgesia.

Patients will be randomised to receive either:
1. An epidural bolus of ketamine before surgery followed by epidural ketamine infusion for 48 to 72 hours
2. A placebo

Intervention type

Drug

Phase

Not Applicable

Drug names

Bupivacaine, ketamine

Primary outcome measures

Incidence and severity of post-amputation pain measured at one year.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2001

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients undergoing lower limb amputation for peripheral vascular disease or as a result of complications of diabetes mellitus
2. Able to give informed consent and cooperate with pain assessment

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

53

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2001

Recruitment end date

01/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Edinburgh Department of Anaesthesia Critical Care and Pain Medicine
Edinburgh
EH3 9YW
United Kingdom

Sponsor information

Organisation

Action Medical Research (UK)

Sponsor details

Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom

Sponsor type

Charity

Website

http://www.action.org.uk/

Funders

Funder type

Charity

Funder name

Action Medical Research (UK)

Alternative name(s)

AMR

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17583431

Publication citations

  1. Results

    Wilson JA, Nimmo AF, Fleetwood-Walker SM, Colvin LA, A randomised double blind trial of the effect of pre-emptive epidural ketamine on persistent pain after lower limb amputation., Pain, 2008, 135, 1-2, 108-118, doi: 10.1016/j.pain.2007.05.011.

Additional files

Editorial Notes