| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN68691928 |
| Date ISRCTN assigned | 16/07/2007 |
| Local reference number(s) | 56481676 |
| Public title | Prospective, double-blind, randomised trial to assess the efficacy of continuous sciatic/posterior tibial nerve blockade via a neural sheath catheter in lower limb amputees |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Lower limb amputation |
| Study hypothesis | That continuous neural sheath infusion of levobupivacaine after major lower limb amputation will reduce the incidence of late phantom pain/phantom limb sensations and stump pain. |
| Design/methodology | Randomised placebo controlled double blind study |
| Research ethics review | Ethics approval received from the Trent Research Ethics Committee on the 13th August 2007 (ref: 07/H0405/42). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients admitted to our vascular unit requiring a below or above knee amputation irrespective of aetiology. |
| Participants - exclusion criteria | 1. Patients not considered for surgical intervention
2. Patients who are deemed unfit to undergo surgery under general anaesthesia
3. Patients unable to operate a Patient-Controlled Analgesia (PCA) device or cooperate with evaluation of pain scores e.g. those with confusional states
4. Patients unwilling to consent
5. Allergy to any study medication |
| Patient information material |
|
| Anticipated start date | 01/07/2007 |
| Anticipated end date | 01/01/2010 |
| Status of trial | Ongoing |
| Target number of participants | 62 |
| Interventions | Perineural infusion of levobupivacaine 1.25 mg/ml versus placebo for 96 hours after surgery. |
| Primary outcome measure(s) | Late stump pain, phantom limb sensations and phantom limb pain up to one year after surgery. |
| Secondary outcome measure(s) | 1. Early postoperative pain and morphine requirements
2. Late effects on mood, physical disability and quality of life, measured using the Late Life disability index (quality of life and disability), the 36-item Short Form health survey (SF-36) inventory, (pain and disability) the McGill pain questionnaire (pain) and the University of Leicester Amputee questionnaire (pain and disability)
Secondary outcomes will be measured at 6 weeks, 3, 6 and 12 months after surgery. |
| Sources of funding | Association of Anaesthetists of Great Britain and Ireland (UK) |
| Sponsor name | University Hospitals of Leicester NHS Trust (UK) |
| Sponsor details | c/o Professor David Rowbotham
Research Office
Leicester General Hospital
Gwendolen Road
Leicester
United Kingdom
LE5 4PW |
| Sponsor telephone | +44 (0)116 258 4199 |
| Sponsor fax | +44 (0)116 258 4226 |
| Sponsor email | djr8@le.ac.uk |
| Sponsor website | http://www.uhl-tr.nhs.uk/ |
| Contact name | Dr Jonathan Thompson |
| Contact details | University Hospitals of Leicester NHS Trust
Department of Anaesthesia Critical Care and Pain Management
Victoria Building
Leicester Royal Infirmary
Leicester
United Kingdom
LE1 5WW |
| Contact telephone | +44 (0)116 258 5291 |
| Contact email | jt23@le.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN68691928 |
| Date last extracted from ISRCTN register | 17/04/2008 |
