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

Lundbeck Foundation

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Analgesic Efficacy

Treatments: Drug: 10 mL ropivacaine 10 mg/mL; Drug: 20 mL ropivacaine 5 mg/mL

Study type: Interventional

Funder types: Other

Identifiers

NCT01012232

H-D-2009-016

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups

low volume local anesthetic

Active Comparator group

Description:

bolus injection of local anesthetic in low volume/high concentration (10 mL, 10 mg/mL)

Treatment:

Drug: 10 mL ropivacaine 10 mg/mL

high volume local anesthetic

Experimental group

Description:

bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL)

Treatment:

Drug: 20 mL ropivacaine 5 mg/mL