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

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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesThe 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) studiedSigns and Symptoms: Pain
Intervention60 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 typeOther
Primary outcome measurePain score, sedation score, PCA morphine consumption and co-analgesic consumption will be noted postoperatively at regular intervals.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/2001
Completion date31/07/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants60 patients
Key inclusion criteriaThe 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 criteriaNot provided at time of registration
Date of first enrolment01/09/2001
Date of final enrolment31/07/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Anaesthetic Department
Gateshead
NE9 6SX
United Kingdom

Sponsor information

Department of Health (UK)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan