The role of glutamate in the development of phantom limb pain
| ISRCTN | ISRCTN48374927 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48374927 |
| Protocol serial number | SP3481 |
| Sponsor | Action Medical Research (UK) |
| Funder | Action Medical Research (UK) |
- 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
Scientific
University of Edinburgh Department of Anaesthesia Critical Care and Pain Medicine
Royal Infirmary of Edinburgh
Lauriston Place
Edinburgh
EH3 9YW
United Kingdom
| Phone | +44 (0)131 536 3652 |
|---|---|
| a.nimmo@ed.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised double blind trial of the effect of pre-emptive epidural ketamine on persistent pain after lower limb amputation |
| Study objectives | To 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) studied | Pain |
| Intervention | All 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 type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bupivacaine, ketamine |
| Primary outcome measure(s) |
Incidence and severity of post-amputation pain measured at one year. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 53 |
| Key inclusion criteria | 1. 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 criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
University of Edinburgh Department of Anaesthesia Critical Care and Pain Medicine
Edinburgh
EH3 9YW
United Kingdom
EH3 9YW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2008 | Yes | No |
