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 |
| Secondary identifying numbers | N0185139350 |
- 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
Scientific
C/O Cdr Lambert's Secretary
Department of General Surgery
Derriford Hospital
Derriford
Plymouth
PL6 8DX
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/07/2003 |
| Completion date | 01/02/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Derriford Hospital
Plymouth
PL6 8DX
United Kingdom
PL6 8DX
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Plymouth Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
