The efficacy of a selective local anaesthetic technique with bupivacaine and epinephrine in total knee replacement surgery. A prospective double blind randomised controlled trial

ISRCTN ISRCTN45935625
DOI https://doi.org/10.1186/ISRCTN45935625
Secondary identifying numbers N0263177699
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
27/06/2011
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J Patel
Scientific

Orthopaedic Surgery
Maple House
2nd Floor
149 Tottenham Court Road
London
W1P 9LL
United Kingdom

Phone +44 020 7380 9412
Email mr_jig_patel@hotmail.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesIs there a reduction in postoperative pain following primary total knee replacement using a selective local anaesthetic infiltration technique?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Total knee replacement (TKR)
InterventionA = Bupivacaine
B = Epinephrine
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Bupivacaine, epinephrine
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/12/2005
Completion date01/12/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants100 planned. As of Feb08, the trial is stopped.
Key inclusion criteria100 patients from Orthopaedic Surgery
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/12/2005
Date of final enrolment01/12/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Orthopaedic Surgery
London
W1P 9LL
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

University College London Hospitals NHS Foundation Trust (UK)

No information available

NHS R&D Support Funding

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