Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0185139350
Study information
Scientific title
Randomised prospective study comparing epidural analgesia perioperatively and 24 hours preoperatively for the prevention of postoperative stump pain and phantom limb pain following major amputation
Acronym
Study hypothesis
Does commencing an epidural 24 hours prior to limb amputation reduce post-operative and phantom limb pain compared with commencing it at the time of the operation?
Aims and Objectives: To demonstrate whether there is a reduction in phantom limb and post operative stump pain as a result of lower limb amputation, when epidural analgesia is commenced 24 hours prior to surgery rather than at the time of surgery.
Study endpoints: To set a precedent for commencing epidural infusion 24 hours before lower limb amputation as the best method of preventing stump and phantom limb pain.
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
Treatment
Patient information sheet
Condition
Surgery: Amputation
Intervention
Study group to be selected from patients scheduled for lower limb amputation who are randomised into two groups:
1. To commence epidural at time of surgery
2. To commence epidural 24hr prior to surgery
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Pain scores to be assessed:
1. Immediately post-operatively. Subjective and objective scoring using a visual analogue score, and a record of morphine requirements for post-operative pain.
2. Phantom limb pain; assessed as present or absent at 3, 6 and 12 month follow up.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/2003
Overall trial end date
01/02/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients above the age of 18
2. All patients undergoing scheduled lower limb amputation will be considered
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Non general anaesthetic (GA)
2. Emergency surgery
3. Unable to give consent
4. Contraindications to epidural
5. Anticoagulated
Recruitment start date
01/07/2003
Recruitment end date
01/02/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Derriford Hospital
Plymouth
PL6 8DX
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Plymouth Hospitals NHS Trust (UK)
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