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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Postoperative Pain Analgesic Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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low volume local anesthetic

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

Group Type ACTIVE_COMPARATOR

10 mL ropivacaine 10 mg/mL

Intervention Type DRUG

high volume local anesthetic

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

Group Type EXPERIMENTAL

20 mL ropivacaine 5 mg/mL

Intervention Type DRUG

Interventions

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20 mL ropivacaine 5 mg/mL

Intervention Type DRUG

10 mL ropivacaine 10 mg/mL

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No