Contact information
Type
Scientific
Primary contact
Dr Richard Venn
ORCID ID
Contact details
Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
+44 (0)1903 205111 x 5151
richard.venn@wash.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0283122707
Study information
Scientific title
Acronym
Study hypothesis
1. To investigate whether intra-articular bupivacaine provides pain relief following ankle arthroscopy
2. To investigate whether intra-articular bupivacaine reduces supplemental analgesia requirements in the post-operative period
Ethics approval
Not provided at time of registration
Study design
Randomised double blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Signs and Symptoms: Pain
Intervention
1. Normal saline
2. 0.5% Bupivacaine
Intervention type
Drug
Phase
Not Applicable
Drug names
bupivacaine
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2003
Overall trial end date
31/03/2006
Reason abandoned
Eligibility
Participant inclusion criteria
48 patients aged ≥18 years old undergoing day case ankle arthroscopy who have given informed written consent.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
48
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/2003
Recruitment end date
31/03/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Worthing & Southlands Hospitals NHS Trust
Worthing
BN11 2DH
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
Sussex NHS Research Consortium (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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17159171
Publication citations
-
Results
Middleton F, Coakes J, Umarji S, Palmer S, Venn R, Panayiotou S, The efficacy of intra-articular bupivacaine for relief of pain following arthroscopy of the ankle., J Bone Joint Surg Br, 2006, 88, 12, 1603-1605, doi: 10.1302/0301-620X.88B12.17740.