- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02006355
Continuous Local Anesthesia Versus Continuous Femoral Nerve Bloc After Total Knee Arthroplasty: Impact on Mean Discharge Aptitude Delay (GLASGOW)
August 24, 2018 updated by: University Hospital, Strasbourg, France
This study aims at comparing continuous local anesthesia and femoral nerve bloc for total knee arthroplasty in terms of post-operative recovery.
Study Overview
Study Type
Interventional
Enrollment (Actual)
36
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
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-
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Illkirch-Graffenstaden, France, 67400
- CCOM-Hôpitaux Universitaires de Strasbourg
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Total knee arthroplasty
- Age > 18 years with social security covering.
- Written informed consent
Exclusion Criteria:
- Age < 18 years
- ASA Physical Status > III
- Body weight < 50 kg
- Latex or silver allergy.
- Loco-regional anesthesia contraindication
- Chronic anticoagulant, corticoid or pain treatment.
- Rivaroxaban or enoxaparin contraindication
- Communication issues
- Patient under guardianship
- Pregnant or breast-feeding patient
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Continuous femoral nerve bloc
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Experimental: Continuous local anesthesia
Continuous local infiltration of local anesthetic in the operated knee.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Discharge ability time period
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
|
Participants will be followed for the duration of hospital stay, an expected average of 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jean-Yves JENNY, MD, Hôpitaux Universitaires de Strasbourg
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 (Actual)
April 1, 2014
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
August 12, 2017
Study Registration Dates
First Submitted
November 27, 2013
First Submitted That Met QC Criteria
December 4, 2013
First Posted (Estimate)
December 10, 2013
Study Record Updates
Last Update Posted (Actual)
August 28, 2018
Last Update Submitted That Met QC Criteria
August 24, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5560
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.
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