- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01012232
Local Anesthetic in Total Knee Arthroplasty (TKA): Volume Versus Concentration
November 10, 2009 updated by: Lundbeck Foundation
The Volume-concentration Relationship of Analgesic Efficacy With Intra-capsular Local Anesthetic in Total Knee Arthroplasty: a Randomized, Double-blind, Cross-over Trial.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Copenhagen, Denmark
- Lundbeck Centre for fast-track hip and knee arthroplasty
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: low volume local anesthetic
bolus injection of local anesthetic in low volume/high concentration (10 mL, 10 mg/mL)
|
|
Experimental: high volume local anesthetic
bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
postoperative pain
Time Frame: 32 hours postoperative
|
32 hours postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
November 10, 2009
First Submitted That Met QC Criteria
November 10, 2009
First Posted (Estimate)
November 11, 2009
Study Record Updates
Last Update Posted (Estimate)
November 11, 2009
Last Update Submitted That Met QC Criteria
November 10, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-D-2009-016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Pain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
Clinical Trials on 10 mL ropivacaine 10 mg/mL
-
Novo Nordisk A/SCompleted
-
Shaheed Zulfiqar Ali Bhutto Medical UniversityCompletedCytokine Release Syndrome | Covid-19 PneumoniaPakistan
-
AmtixBio Co., Ltd.Novotech (Australia) Pty LimitedCompleted
-
Aposense Ltd.CompletedSolid Tumors | Brain Metastases
-
Adynxx, Inc.CompletedPostsurgical PainUnited States
-
Novo Nordisk A/SCompletedHealthy Volunteers - Haemophilia AGermany
-
Ampio Pharmaceuticals. Inc.Completed
-
UCB Pharma SACompleted
-
Dr Cipto Mangunkusumo General HospitalActive, not recruitingMechanical Ventilation ComplicationIndonesia