| Source of record | UK Trials |
| ISRCTN | ISRCTN62584127 |
| Date ISRCTN assigned | 12/09/2003 |
| Local reference number(s) | N0009109897 |
| Public title | The morphine sparing effect of continuous intraarticular infusion of bupivacaine following knee arthroplasty - a randomised double blind placebo controlled trial |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Signs and Symptoms: Pain |
| Study hypothesis | The continuous infusion of bupivacaine intraarticularly will decrease the postoperative morphine requirement following knee arthroplasty surgery. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 60 Patients. The study population will consist of patients admitted by the Department of Orthopaedics, QEH, for unilateral primary knee arthroplasty who are willing to take part in the study. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/09/2001 |
| Anticipated end date | 31/07/2003 |
| Status of trial | Completed |
| Target number of participants | 60 |
| Interventions | Sixty patients scheduled to undergo primary knee replacement will be divided into two groups of 30 each. All of them will receive spinal anaesthesia for the surgical procedure and at the end of the procedure, a 18 G epidural catheter will be inserted into the joint aseptically. Both the groups will receive a continuous infusion of either 0.25% bupicacaine or normal saline respectively into the joint for 48 h in the postoperative period. All of them will receive morphine PCA postoperatively for analgesia along with non-steroidal anti-inflamatory agents as per protocol. The prospective pain relief, morphine and other analgesic requirements will be assessed. The side effects, if any, will be noted. The results will be analysed statistically. |
| Primary outcome measure(s) | Pain score, sedation score, PCA morphine consumption and co-analgesic consumption will be noted postoperatively at regular intervals. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Gateshead Health NHS Trust |
| Sponsor name | Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK) |
| Sponsor details | The Department of Health
Richmond House
79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 (0)20 7307 2623 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.doh.gov.uk |
| Contact name | Dr Philip Mathew |
| Contact details | Anaesthetic Department
Gateshead Health NHS Trust
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
United Kingdom
NE9 6SX |
| Contact telephone | +44 0191 403 2046 |
| Contact fax | +44 0191 4032827 |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN62584127 |
| Date last extracted from ISRCTN register | 17/04/2008 |
