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

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.

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Key information

Conditions

Postoperative Pain Analgesic Efficacy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lundbeck Centre for fast-track hip and knee arthroplasty

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

20 mL ropivacaine 5 mg/mL

Drug

10 mL ropivacaine 10 mg/mL

Drug

Primary outcomes

postoperative pain

Time frame: 32 hours postoperative

Sponsors and collaborators

Lead sponsor

Lundbeck Foundation

Other

Registry information

Official study title

The Volume-concentration Relationship of Analgesic Efficacy With Intra-capsular Local Anesthetic in Total Knee Arthroplasty: a Randomized, Double-blind, Cross-over Trial.

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Nov 11, 2009
Registry last updated: Nov 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed