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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
Lundbeck Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring total knee arthroplasty, postoperative pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 10, 2009
Last Updated
November 10, 2009
Sponsor
Lundbeck Foundation
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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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