A randomised double-blind trial to investigate the efficacy of intra-articular bupivacaine for pain relief following ankle arthroscopy

ISRCTN ISRCTN07238689
DOI https://doi.org/10.1186/ISRCTN07238689
Secondary identifying numbers N0283122707
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
18/11/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Richard Venn
Scientific

Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom

Phone +44 (0)1903 205111 x 5151
Email richard.venn@wash.nhs.uk

Study information

Study designRandomised double blind trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSigns and Symptoms: Pain
Intervention1. Normal saline
2. 0.5% Bupivacaine
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)bupivacaine
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/03/2003
Completion date31/03/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants48
Key inclusion criteria48 patients aged ≥18 years old undergoing day case ankle arthroscopy who have given informed written consent.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/03/2003
Date of final enrolment31/03/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Worthing & Southlands Hospitals NHS Trust
Worthing
BN11 2DH
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

Sussex NHS Research Consortium (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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2006 Yes No