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

Phase 4

Completed

• Conditions: Postoperative Pain; Analgesic Efficacy
• Interventions: Drug: 20 mL ropivacaine 5 mg/mL; Drug: 10 mL ropivacaine 10 mg/mL

• Registration Number: NCT01012232
• Lead Sponsor: Lundbeck Foundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2009-11
• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-10
• Last Update Submitted: 2009-11-10
• Study First Posted: 2009-11-11
• Last Update Posted: 2009-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
high volume local anesthetic	20 mL ropivacaine 5 mg/mL	bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL)
low volume local anesthetic	10 mL ropivacaine 10 mg/mL	bolus injection of local anesthetic in low volume/high concentration (10 mL, 10 mg/mL)

Primary Outcome Measures

Name	Time	Method
postoperative pain	32 hours postoperative

Trial Locations

Locations (1)

Lundbeck Centre for fast-track hip and knee arthroplasty; 🇩🇰 Copenhagen, Denmark