Condition category
Musculoskeletal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
07/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Matt Dawson

ORCID ID

Contact details

Consultant Trauma and Orthopaedic Surgeon
North Cumbria Acute Hospitals NHS Trust
Cumberland Infirmary
Carlisle
CA2 7HY
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes