Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
28/11/2014
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

Mr T Edwards

ORCID ID

Contact details

C/O Cdr Lambert's Secretary
Department of General Surgery
Derriford Hospital
Derriford
Plymouth
PL6 8DX
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes