- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02451605
Regional Anesthesia for Knee Prothesis Surgery
May 21, 2015 updated by: Pierre Goffin, University of Liege
Regional Blockade for Knee Prothesis Surgery: Comparison Between Femoral, Sciatic and Adductor Canal Block
Comparison of the analgesics blocks (femoral, adductor canal and sciatic subgluteal nerve) for total replacement knee surgery.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Adductor canal block shows a beneficial effect for knee surgery. Mainly because he prevent for muscular weakness; adverse effect meet with femoral block and delaying the early active mobilization.
The investigators want to compare the efficacy and safety of this block compared to the femoral and sciatic block.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
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
-
-
-
Liege, Belgium, 4000
- University og Liege, University Hospital
-
-
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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients scheduled for total knee replacement surgery.
Exclusion Criteria:
- refusal to study,
- coagulation disorder,
- infection at the puncture site,
- preexisting neuropathy,
- allergy to local anesthetics,
- renal or hepatocellular insufficiency,
- context of chronic pain,
- drugs abuse,
- pregnant 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 |
---|---|
Active Comparator: Femoral nerve blockade
In this group, patient will benefit of an ultrasound guided femoral nerve blockade with continuous catheter infusion as (initial bolus of 20ml of ropivacaine 0.75% follow with 7ml/hour of ropivacaine 0.2%) as analgesic nerve blockade for total knee replacement surgery.
|
Analgesic nerve blockade (Ropivacaine) for total knee replacement surgery.
Other Names:
Total knee replacement surgery.
|
Active Comparator: Adductor canal blockade
In this group, patient will benefit of an ultrasound guided adductor canal blockade with continuous catheter infusion (initial bolus of 20ml of ropivacaine 0.75% follow with 7ml/hour of ropivacaine 0.2%) as analgesic nerve blockade for for total knee replacement surgery.
|
Analgesic nerve blockade (Ropivacaine) for total knee replacement surgery.
Other Names:
Total knee replacement surgery.
|
Active Comparator: Subgluteal sciatic nerve blockade
In this group, patient will benefit of an ultrasound guided subgluteal sciatic nerve blockade with continuous catheter infusion (initial bolus of 20ml of ropivacaine 0.75% follow with 7ml/hour of ropivacaine 0.2%) as analgesic nerve blockade for total knee replacement surgery.
|
Analgesic nerve blockade (Ropivacaine) for total knee replacement surgery.
Other Names:
Total knee replacement surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain measurement with numeric pain scale : from 0 to 10 (maximal pain) in rest condition
Time Frame: up to day 7
|
Pain assessment and evolution in postoperative period (passive condition)
|
up to day 7
|
Pain measurement with numeric pain scale (from 0 to 10) during active motorized mobilization (Kinetic)
Time Frame: up to day 7
|
Pain assessment and evolution in postoperative period (active condition)
|
up to day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postintervention nausea vomiting
Time Frame: at hour 0, at hours 6, at day 1
|
question : present or not
|
at hour 0, at hours 6, at day 1
|
Patient satisfaction
Time Frame: at day 1
|
Questionnaire of patient felling and satisfaction.
Choice within gradual felling : bad, middle, good, excellent
|
at day 1
|
Opioid consumption
Time Frame: up to 48 hours
|
doses of piritramid (synthetic opioid) administrated with patient control rescue analgesia device.
|
up to 48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jean-Francois Brichant, University of Liege
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, 2015
Primary Completion (Anticipated)
November 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
May 12, 2015
First Submitted That Met QC Criteria
May 21, 2015
First Posted (Estimate)
May 22, 2015
Study Record Updates
Last Update Posted (Estimate)
May 22, 2015
Last Update Submitted That Met QC Criteria
May 21, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-000677-39
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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