Local Anesthetic in Total Knee Arthroplasty (TKA): Volume Versus Concentration

This study has been completed.
Sponsor:
Information provided by:
Lundbeck Foundation
ClinicalTrials.gov Identifier:
NCT01012232
First received: November 10, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

November 10, 2009
November 10, 2009
June 2009
October 2009   (final data collection date for primary outcome measure)
postoperative pain [ Time Frame: 32 hours postoperative ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Local Anesthetic in Total Knee Arthroplasty (TKA): Volume Versus Concentration
The Volume-concentration Relationship of Analgesic Efficacy With Intra-capsular Local Anesthetic in Total Knee Arthroplasty: a Randomized, Double-blind, Cross-over Trial.

In a randomized, double-blind, cross-over trial, 48 patients scheduled for total knee arthroplasty with placement of an intracapsular catheter will be randomized to receive bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL) or low volume/high concentration (10 mL, 10 mg/mL) 6 and 24 hours postoperatively, and pain will be assessed at rest and with mobilization for 2 hours after injections.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Postoperative Pain
  • Analgesic Efficacy
  • Drug: 20 mL ropivacaine 5 mg/mL
  • Drug: 10 mL ropivacaine 10 mg/mL
  • Active Comparator: low volume local anesthetic
    bolus injection of local anesthetic in low volume/high concentration (10 mL, 10 mg/mL)
    Intervention: Drug: 10 mL ropivacaine 10 mg/mL
  • Experimental: high volume local anesthetic
    bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL)
    Intervention: Drug: 20 mL ropivacaine 5 mg/mL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Scheduled for total knee arthroplasty
  • Able to give informed oral and written consent to participate

Exclusion Criteria:

  • Treatment with opioids or steroids, rheumatoid arthritis or other immunological diseases
  • History of stroke or any neurological or psychiatric disease potentially influencing pain perception (e.g. depression, diabetic neuropathy etc.)
  • Allergies to any of the drugs administered.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01012232
H-D-2009-016
No
Lasse Andersen, The Lundbeck Centre for Fast-track Hip and Knee Arthroplasty
Lundbeck Foundation
Not Provided
Not Provided
Lundbeck Foundation
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP