The role of glutamate in the development of phantom limb pain

ISRCTN ISRCTN48374927
DOI https://doi.org/10.1186/ISRCTN48374927
Secondary identifying numbers SP3481
Submission date
01/03/2001
Registration date
01/03/2001
Last edited
14/01/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Alastair F Nimmo
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Scientific titleA randomised double blind trial of the effect of pre-emptive epidural ketamine on persistent pain after lower limb amputation
Study objectivesTo assess the effect of pre-emptively modulating sensory input with epidural ketamine (an NMDA antagonist) on post-amputation pain and sensory processing.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPain
InterventionAll 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Bupivacaine, ketamine
Primary outcome measureIncidence and severity of post-amputation pain measured at one year.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2001
Completion date01/01/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants53
Key inclusion criteria1. 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2001
Date of final enrolment01/01/2007

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

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

Sponsor information

Action Medical Research (UK)
Charity

Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom

http://www.action.org.uk/
ROR logo https://ror.org/01wcqa315

Funders

Funder type

Charity

Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
actionmedres, action medical research for children, AMR
Location
United Kingdom

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2008 Yes No
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