Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0055166048
Study information
Scientific title
Acronym
Study hypothesis
Does the use of a continuous infusion of local anaesthetic (levobupivicaine) into the knee joint after a unicondylar knee replacement (UKR) (half knee replacement) give better pain relief than a saline infusion?
Ethics approval
Not provided at time of registration
Study design
Randomised triple-blinded controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Musculoskeletal Diseases: Unicondylar Knee Replacement (UKR)
Intervention
1. One group receiving a postoperative intra-articular infusion of local anaesthetic
2. Control group receiving a saline infusion
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Pain - Visual Analogue score, use of additional analgesia postop (e.g. PCA, Oramorph).
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2005
Overall trial end date
01/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/2005
Recruitment end date
01/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Trauma and Orthopaedic Surgeon
Carlisle
CA2 7HY
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Cumbria Acute Hospitals 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