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

ISRCTN	ISRCTN33846889
DOI	https://doi.org/10.1186/ISRCTN33846889
Protocol serial number	N0185139350
Sponsor	Department of Health
Funder	Plymouth Hospitals NHS Trust (UK)

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 28/11/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr T Edwards
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/02/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Patients above the age of 18 2. All patients undergoing scheduled lower limb amputation will be considered
Key exclusion criteria	1. Non general anaesthetic (GA) 2. Emergency surgery 3. Unable to give consent 4. Contraindications to epidural 5. Anticoagulated
Date of first enrolment	01/07/2003
Date of final enrolment	01/02/2005

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Derriford Hospital

Plymouth
PL6 8DX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan