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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012232
• Other study ID #: H-D-2009-016
• Status: Completed
• Phase: Phase 4
• First received: November 10, 2009
• Last updated: November 10, 2009
• Start date: June 2009
• Est. completion date: October 2009

Study information

• Verified date: November 2009
• Source: Lundbeck Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesic Efficacy
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• 20 mL ropivacaine 5 mg/mL

• 10 mL ropivacaine 10 mg/mL

Locations

Country	Name	City	State
Denmark	Lundbeck Centre for fast-track hip and knee arthroplasty	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain		32 hours postoperative	No