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

Sponsor

Lundbeck Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT01012232

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Analgesic Efficacy	Drug: 20 mL ropivacaine 5 mg/mL Drug: 10 mL ropivacaine 10 mg/mL	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: low volume local anesthetic bolus injection of local anesthetic in low volume/high concentration (10 mL, 10 mg/mL)	Drug: 10 mL ropivacaine 10 mg/mL
Experimental: high volume local anesthetic bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL)	Drug: 20 mL ropivacaine 5 mg/mL

Arm

Intervention/Treatment

Active Comparator: low volume local anesthetic

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

Drug: 10 mL ropivacaine 10 mg/mL

Experimental: high volume local anesthetic

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

Drug: 20 mL ropivacaine 5 mg/mL

Outcome Measures

Primary Outcome Measures

postoperative pain [32 hours postoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lundbeck Centre for fast-track hip and knee arthroplasty	Copenhagen		Denmark

Sponsors and Collaborators

Lundbeck Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01012232

Other Study ID Numbers:

H-D-2009-016

First Posted:

Nov 11, 2009

Last Update Posted:

Nov 11, 2009

Last Verified:

Nov 1, 2009

Keywords provided by , ,

total knee arthroplasty

postoperative pain

Additional relevant MeSH terms:

Pain, Postoperative

Ropivacaine

Study Results

No Results Posted as of Nov 11, 2009