Total Knee Prosthesis With Continuous Block of Adductor Canal and Outcome
NCT ID: NCT02082067
Last Updated: 2016-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2014-03-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Adductor canal
All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
Adductor canal
Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert in adductor canal through tuohy needle (18G, 100mm length) under ultrasound guidance.
Spinal Anesthesia
Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.
Local anesthetic infusion
Continuous infusion of levobupivacaine 0,125% at 8ml/h rate through perinervous catheter until 5th postoperative day.
Intravenous analgesia
Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.
Ropivacaine 0,75%
Levobupivacaine 0,5%
Levobupivacaine 0,125%
Ketorolac 30mg
Morphine
stimulong sono, Pajunk, Germany
Femoral
All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
Femoral
Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert between femoral nerve and femoral artery through tuohy needle (18G, 100mm length) under ultrasound guidance.
Spinal Anesthesia
Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.
Local anesthetic infusion
Continuous infusion of levobupivacaine 0,125% at 8ml/h rate through perinervous catheter until 5th postoperative day.
Intravenous analgesia
Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.
Ropivacaine 0,75%
Levobupivacaine 0,5%
Levobupivacaine 0,125%
Ketorolac 30mg
Morphine
stimulong sono, Pajunk, Germany
Controls
No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.
Spinal Anesthesia
Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.
Intravenous analgesia
Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.
Levobupivacaine 0,5%
Ketorolac 30mg
Morphine
Interventions
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Adductor canal
Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert in adductor canal through tuohy needle (18G, 100mm length) under ultrasound guidance.
Femoral
Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert between femoral nerve and femoral artery through tuohy needle (18G, 100mm length) under ultrasound guidance.
Spinal Anesthesia
Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.
Local anesthetic infusion
Continuous infusion of levobupivacaine 0,125% at 8ml/h rate through perinervous catheter until 5th postoperative day.
Intravenous analgesia
Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.
Ropivacaine 0,75%
Levobupivacaine 0,5%
Levobupivacaine 0,125%
Ketorolac 30mg
Morphine
stimulong sono, Pajunk, Germany
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* neurological disorders
* coagulation disorders
* rheumatoid arthritis
* chronic opioids therapy
* allergy to local anesthetic
18 Years
ALL
No
Sponsors
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ASST Gaetano Pini-CTO
OTHER
Responsible Party
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Gianluca Cappelleri
Medical Doctor
Principal Investigators
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Gianluca Cappelleri, M.D.
Role: PRINCIPAL_INVESTIGATOR
ASST Gaetano Pini-CTO
Locations
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Istituto ortopedico Gaetano Pini
Milan, , Italy
Countries
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Other Identifiers
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IOGPGC05-14
Identifier Type: -
Identifier Source: org_study_id
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