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

Lundbeck Foundation1 site in 1 country48 target enrollmentJune 2009

ConditionsPostoperative Pain Analgesic Efficacy

Interventions10 mL ropivacaine 10 mg/mL 20 mL ropivacaine 5 mg/mL

Drugs20 mL ropivacaine 5 mg/mL 10 mL ropivacaine 10 mg/mL

Overview

Phase: Phase 4
Intervention: 10 mL ropivacaine 10 mg/mL
Conditions: Postoperative Pain
Sponsor: Lundbeck Foundation
Enrollment: 48
Locations: 1
Primary Endpoint: postoperative pain
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

October 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Lundbeck Foundation

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.