A Prospective Randomised Controlled Trial of the Immediate Post-operative Intra-articular Local Anaesthetic Infusion Using Infusion Pump in Total Knee Arthroplasty.

ISRCTN ISRCTN32365985
DOI https://doi.org/10.1186/ISRCTN32365985
Protocol serial number N0035118427
Sponsor Department of Health
Funder Basildon and Thurrock University Hospitals NHS Trust (UK), NHS R&D Support Funding
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
11/04/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
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

Mr Vijesh Rao
Scientific

Orthopaedic Research Fellow
Basildon University Hospital
Nethermayne
Basildon
SS16 5NL
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesTo determine whether a local infusion of Bupivacaine provides more efficient and cost effective postoperative analgesia than current standard practices
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSigns and Symptoms: Pain
InterventionLocal infusion of Bupivacaine provides vs current standard practices
Intervention typeOther
Primary outcome measure(s)

Pain assessment, amount of analgesic used, amount of opioid analgesic used and its side effects, length of inpatient stay, cost of surgical procedure

Key secondary outcome measure(s)

Not provided at time of registration

Completion date30/09/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration50
Key inclusion criteria50 patients undergoing total knee joint arthroplasty
Key exclusion criteriaNot provided at time of registration
Date of first enrolment30/09/2002
Date of final enrolment30/09/2004

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Orthopaedic Research Fellow
Basildon
SS16 5NL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan