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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01012232
First Posted: November 11, 2009
Last Update Posted: November 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Lundbeck Foundation
  Purpose
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.

Condition Intervention Phase
Postoperative Pain Analgesic Efficacy Drug: 20 mL ropivacaine 5 mg/mL Drug: 10 mL ropivacaine 10 mg/mL Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Lundbeck Foundation:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: 32 hours postoperative ]

Enrollment: 48
Study Start Date: June 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: low volume local anesthetic
bolus injection of local anesthetic in low volume/high concentration (10 mL, 10 mg/mL)
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)
Drug: 20 mL ropivacaine 5 mg/mL

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012232


Locations
Denmark
Lundbeck Centre for fast-track hip and knee arthroplasty
Copenhagen, Denmark
Sponsors and Collaborators
Lundbeck Foundation
  More Information

Responsible Party: Lasse Andersen, The Lundbeck Centre for Fast-track Hip and Knee Arthroplasty
ClinicalTrials.gov Identifier: NCT01012232     History of Changes
Other Study ID Numbers: H-D-2009-016
First Submitted: November 10, 2009
First Posted: November 11, 2009
Last Update Posted: November 11, 2009
Last Verified: November 2009

Keywords provided by Lundbeck Foundation:
total knee arthroplasty
postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anesthetics
Ropivacaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents