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Total Knee Prosthesis With Continuous Block of Adductor Canal and Outcome

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ClinicalTrials.gov Identifier: NCT02082067
Recruitment Status : Withdrawn
First Posted : March 10, 2014
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Gianluca Cappelleri, ASST Gaetano Pini-CTO

Brief Summary:
Aim of this study is to evaluate the effects of the adductor canal block on the early and medium term ( 1 month) rehabilitation compared to the continuous femoral block commonly used in the knee prosthesis.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Procedure: Adductor canal Procedure: Femoral Procedure: Spinal Anesthesia Procedure: Local anesthetic infusion Procedure: Intravenous analgesia Drug: Ropivacaine 0,75% Drug: Levobupivacaine 0,5% Drug: Levobupivacaine 0,125% Drug: Ketorolac 30mg Drug: Morphine Device: stimulong sono, Pajunk, Germany Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Total Knee Arthroplasty & Outcome: A Prospective Randomized Comparison Between Adductor Canal Block and Femoral Nerve Block
Study Start Date : March 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: 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.
Procedure: Adductor canal
Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert in adductor canal through tuohy needle (18G, 100mm length) under ultrasound guidance.

Procedure: Spinal Anesthesia
Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.

Procedure: Local anesthetic infusion
Continuous infusion of levobupivacaine 0,125% at 8ml/h rate through perinervous catheter until 5th postoperative day.

Procedure: Intravenous analgesia
Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.

Drug: Ropivacaine 0,75%
Drug: Levobupivacaine 0,5%
Drug: Levobupivacaine 0,125%
Drug: Ketorolac 30mg
Drug: Morphine
Device: stimulong sono, Pajunk, Germany
Active Comparator: 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.
Procedure: 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.

Procedure: Spinal Anesthesia
Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.

Procedure: Local anesthetic infusion
Continuous infusion of levobupivacaine 0,125% at 8ml/h rate through perinervous catheter until 5th postoperative day.

Procedure: Intravenous analgesia
Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.

Drug: Ropivacaine 0,75%
Drug: Levobupivacaine 0,5%
Drug: Levobupivacaine 0,125%
Drug: Ketorolac 30mg
Drug: Morphine
Device: stimulong sono, Pajunk, Germany
Placebo Comparator: Controls
No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.
Procedure: Spinal Anesthesia
Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.

Procedure: Intravenous analgesia
Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.

Drug: Levobupivacaine 0,5%
Drug: Ketorolac 30mg
Drug: Morphine



Primary Outcome Measures :
  1. Up and Go test [ Time Frame: 5th postoperative day ]
    Knee functional evaluation at 5th postoperative day. "up and go" test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair


Secondary Outcome Measures :
  1. VAS score [ Time Frame: up to POD5 ]
    Evaluation of VAS static and VAS dynamic during hospital stay

  2. Morphine request [ Time Frame: up to POD5 ]
    Opioids consumption will be recorded throughout postoperative period

  3. Range of motion [ Time Frame: 5th postoperative day ]
    Physiotherapist measures the maximum active/passive range of motion

  4. Falling risk [ Time Frame: 5th postoperative day ]
    Evaluation of falling risk with Berg Balance Scale

  5. Quadriceps strength [ Time Frame: 5th postoperative day ]
    evaluate muscle strength with an isometric force dynamometer to measure the force produced during a maximum voluntary isometric contraction in a lying position by the knee flex to 90°.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing total knee arthroplasty

Exclusion Criteria:

  • diabetes
  • neurological disorders
  • coagulation disorders
  • rheumatoid arthritis
  • chronic opioids therapy
  • allergy to local anesthetic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082067


Locations
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Italy
Istituto ortopedico Gaetano Pini
Milan, Italy
Sponsors and Collaborators
ASST Gaetano Pini-CTO
Investigators
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Principal Investigator: Gianluca Cappelleri, M.D. ASST Gaetano Pini-CTO
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Responsible Party: Gianluca Cappelleri, Medical Doctor, ASST Gaetano Pini-CTO
ClinicalTrials.gov Identifier: NCT02082067    
Other Study ID Numbers: IOGPGC05-14
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Ketorolac
Morphine
Anesthetics
Ropivacaine
Levobupivacaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action