Local Anesthetic in Total Knee Arthroplasty (TKA): Volume Versus Concentration
Primary Purpose
Postoperative Pain, Analgesic Efficacy
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
20 mL ropivacaine 5 mg/mL
10 mL ropivacaine 10 mg/mL
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring total knee arthroplasty, postoperative pain
Eligibility Criteria
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.
Sites / Locations
- Lundbeck Centre for fast-track hip and knee arthroplasty
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
low volume local anesthetic
high volume local anesthetic
Arm Description
bolus injection of local anesthetic in low volume/high concentration (10 mL, 10 mg/mL)
bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL)
Outcomes
Primary Outcome Measures
postoperative pain
Secondary Outcome Measures
Full Information
NCT ID
NCT01012232
First Posted
November 10, 2009
Last Updated
November 10, 2009
Sponsor
Lundbeck Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01012232
Brief Title
Local Anesthetic in Total Knee Arthroplasty (TKA): Volume Versus Concentration
Official Title
The Volume-concentration Relationship of Analgesic Efficacy With Intra-capsular Local Anesthetic in Total Knee Arthroplasty: a Randomized, Double-blind, Cross-over Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Lundbeck Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Analgesic Efficacy
Keywords
total knee arthroplasty, postoperative pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low volume local anesthetic
Arm Type
Active Comparator
Arm Description
bolus injection of local anesthetic in low volume/high concentration (10 mL, 10 mg/mL)
Arm Title
high volume local anesthetic
Arm Type
Experimental
Arm Description
bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL)
Intervention Type
Drug
Intervention Name(s)
20 mL ropivacaine 5 mg/mL
Intervention Type
Drug
Intervention Name(s)
10 mL ropivacaine 10 mg/mL
Primary Outcome Measure Information:
Title
postoperative pain
Time Frame
32 hours postoperative
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Lundbeck Centre for fast-track hip and knee arthroplasty
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
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Local Anesthetic in Total Knee Arthroplasty (TKA): Volume Versus Concentration
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