Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
18/11/2009
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

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes