Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0009109897
Study information
Scientific title
Acronym
Study hypothesis
The continuous infusion of bupivacaine intraarticularly will decrease the postoperative morphine requirement following knee arthroplasty surgery.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/09/2001
Overall trial end date
31/07/2003
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
60 patients
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2001
Recruitment end date
31/07/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthetic Department
Gateshead
NE9 6SX
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Gateshead Health NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary