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Adductor Canal Block and Recovery After Total Knee Replacement Surgery (ACB in TKA)

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ClinicalTrials.gov Identifier: NCT02411149
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
This study aims to compare the functional recovery of patients undergoing Total Knee Arthroplasty based on the administration of an adductor canal block during their anesthesia treatment

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Drug: Adductor Canal Block Drug: Adductor Canal Block with Morphine Drug: Local Infiltration Phase 4

Detailed Description:

The period after total knee replacement (TKR) surgery is known to be painful for the first 24 hours, lasting up to 3 days in many cases. Successful management of pain after TKR is regarded as necessary to early recovery, rehabilitation and timely discharge. Severe pain following major joint arthroplasty can hinder early rehabilitation, may result in prolonged hospitalization and is a strong predictor of persistent pain beyond 3 months. Adequate analgesia following TKR is paramount to early recovery, rehabilitation and timely discharge. Therefore early postoperative analgesic and rehabilitation goals are intricately related.

Until now, different methods of pain treatment have been used, including intravenous narcotic pain medication, continuous femoral nerve block (numbing medication to a nerve in the thigh) and epidural analgesia (identical to the numbing method for childbirth). These are all effective methods but each is limited by side effects. In recent years, research has focused on administering local anesthetic further down in the leg, trying to minimize quadriceps muscle weakness while giving adequate pain relief after surgery. Local Infiltration Analgesia (LIA) and Adductor Canal Block (ACB) are examples of new farther sites of administration.

The purpose of this study is to determine which combination of analgesic interventions is the most effective treatment for pain and improvement in functional outcome for TKR.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adductor Canal Block and Functional Recovery After Total Knee Arthroplasty. A Double-Blind, Randomized Controlled Trial
Study Start Date : April 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Placebo Comparator: Local Inflitration Only

This group will receive LIA and saline solution (placebo) in the adductor canal block with NO morphine in the spinal anesthesia:

  • 30 ml normal saline
  • 3ml 0.5% preservative-free bupivacaine
Drug: Local Infiltration
30 ml normal saline in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine, in addition to the local infiltration.
Other Name: saline

Active Comparator: Adductor Canal Block

This group will receive LIA and the standard local anesthetic in the ACB with NO morphine in the spinal anesthetic:

  • ropivacaine 0.5% with 1:400,000 epinephrine
  • 3ml 0.5% preservative-free bupivacaine
Drug: Adductor Canal Block
Use of ropivacaine 0.5% with 1:400,000 epinephrine in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine.
Other Name: ropivacaine with epinephrine

Active Comparator: Adductor Canal Block with Morphine

This group will receive LIA with local anesthetic in the ACB and morphine in the spinal anesthetic:

  • ropivacaine 0.5% with 1:400,000 epinephrine
  • 3ml 0.5% preservative-free bupivacaine with 100mcg of intrathecal morphine (0.1ml of intrathecal morphine 1mg/ml)
Drug: Adductor Canal Block with Morphine
Use of ropivacaine 0.5% with 1:400,000 epinephrine in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine and 100mcg of intrathecal morphine (0.1ml of intrathecal morphine 1mg/ml)
Other Name: ropivacaine with epinephrine and spinal intrathecal morphine




Primary Outcome Measures :
  1. Timed Up and Go test [ Time Frame: 2-3 days post srugery ]
    TUG test reflects the time it takes a subject to stand up from a standard height armchair, walk 3 meters, walk back to the chair and sit down. It intends to assess a patient's global mobility as well as balance and risk of falling.


Secondary Outcome Measures :
  1. Pain outcome - NRS [ Time Frame: 2-3 days post surgery ]
    a) Pain scores assessed with an 11 point verbal numeric rating scale (NRS) where 0 is "no pain" and 10 is "the worst pain imaginable", both at rest and during active physiotherapy (measured daily for 3 days post-operatively) .

  2. Analgesic outcomes - Cumulative systemic opioid consumption [ Time Frame: 2-3 days post surgery ]
    Cumulative systemic opioid consumption measured as oral morphine mg equivalents (daily for 3 days post-operatively).

  3. Analgesic outcomes - Proportion of patients who required "rescue" intravenous patient controlled analgesia [ Time Frame: 2-3 days post surgery ]
    Proportion of patients who required "rescue" intravenous patient controlled analgesia (iv PCA) anytime in the post-operative period.

  4. Analgesic outcomes - Incidence of opioid-related side effects [ Time Frame: 2-3 days post surgery ]
    Incidence of opioid-related side effects

  5. Secondary short-term physical and performance-based functional outcome measures - Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees [ Time Frame: 2-3 days post surgery ]
    Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees (measured daily for 3 days post-operatively)

  6. Secondary short-term physical and performance-based functional outcome measures - Distance walked [ Time Frame: 2-3 days post surgery ]
    Distance walked

  7. Secondary short-term physical and performance-based functional outcome measures - Hospital length of stay [ Time Frame: 2-3 days post surgery ]
    Hospital length of stay

  8. Secondary short-term physical and performance-based functional outcome measures - Discharge destination [ Time Frame: 2-3 days post surgery ]
    Discharge destination (home or rehabilitation facility)

  9. Medium-term self-reported functional outcome measures - WOMAC [ Time Frame: baseline and 2-3 days post surgery ]
    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measured at baseline and at 3 months post-operatively

  10. Medium-term self-reported functional outcome measures - LEFS [ Time Frame: baseline and 2-3 days post surgery ]
    Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists Physical Status I-III
  • 18 - 80 years of age
  • BMI 18 - 40
  • Scheduled for elective total knee replacement under spinal anesthesia
  • Able to ambulate independently with a standard wheeled walker as maximum mobility aid

Exclusion Criteria:

  • Revision knee arthroplasty
  • Bilateral knee arthroplasty
  • Lack of mental ability to provide informed consent
  • Neuropathic pain or sensory disorders of the surgical limb
  • Contraindication to regional anesthesia (intolerance to the study drugs, bleeding diathesis, coagulopathy, malignancy or infection at the site of block)
  • Chronic opioid use defined as > 30 mg of daily oral morphine equivalents

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): NCT02411149


Locations
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Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Anahi Perlas, MD University of Toronto. University Health Network. Toronto Western Hospital.
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02411149    
Other Study ID Numbers: 13-7016-A
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Keywords provided by University Health Network, Toronto:
Adductor Canal Block
Total Knee Arthroplasty
Additional relevant MeSH terms:
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Epinephrine
Racepinephrine
Morphine
Ropivacaine
Epinephryl borate
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents