The morphine-sparing effect of continuous intra-articular infusion of bupivacaine following knee arthroplasty - a randomised double-blind placebo-controlled trial
| ISRCTN | ISRCTN62584127 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62584127 |
| Secondary identifying numbers | N0009109897 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 01/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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
Dr Philip Mathew
Scientific
Scientific
Anaesthetic Department
Gateshead Health NHS Trust
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
| Phone | +44 (0)191 403 2046 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | The continuous infusion of bupivacaine intraarticularly will decrease the postoperative morphine requirement following knee arthroplasty surgery. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Pain |
| Intervention | 60 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. |
| Intervention type | Other |
| Primary outcome measure | Pain score, sedation score, PCA morphine consumption and co-analgesic consumption will be noted postoperatively at regular intervals. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2001 |
| Completion date | 31/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 60 patients |
| Key inclusion criteria | 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2001 |
| Date of final enrolment | 31/07/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Anaesthetic Department
Gateshead
NE9 6SX
United Kingdom
NE9 6SX
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Gateshead Health 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 |
