Adductor Canal Block and Recovery After Total Knee Replacement Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Adductor Canal Block and Functional Recovery After Total Knee Arthroplasty. A Double-Blind, Randomized Controlled Trial

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Drug: Adductor Canal Block
* Drug: Adductor Canal Block with Morphine
* Drug: Local Infiltration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Local Inflitration Only<br>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<br>* 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.<br>* Other names: saline;|
| Active Comparator: Adductor Canal Block<br>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<br>* 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.<br>* Other names: ropivacaine with epinephrine;|
| Active Comparator: Adductor Canal Block with Morphine<br>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<br>* 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)<br>* Other names: ropivacaine with epinephrine and spinal intrathecal morphine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go test | 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. | 2-3 days post srugery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain outcome - NRS | 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) . | 2-3 days post surgery | 
| Analgesic outcomes - Cumulative systemic opioid consumption | Cumulative systemic opioid consumption measured as oral morphine mg equivalents (daily for 3 days post-operatively). | 2-3 days post surgery | 
| Analgesic outcomes - Proportion of patients who required rescue intravenous patient controlled analgesia | Proportion of patients who required rescue intravenous patient controlled analgesia (iv PCA) anytime in the post-operative period. | 2-3 days post surgery | 
| Analgesic outcomes - Incidence of opioid-related side effects | Incidence of opioid-related side effects | 2-3 days post surgery | 
| Secondary short-term physical and performance-based functional outcome measures - Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees | Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees (measured daily for 3 days post-operatively) | 2-3 days post surgery | 
| Secondary short-term physical and performance-based functional outcome measures - Distance walked | Distance walked | 2-3 days post surgery | 
| Secondary short-term physical and performance-based functional outcome measures - Hospital length of stay | Hospital length of stay | 2-3 days post surgery | 
| Secondary short-term physical and performance-based functional outcome measures - Discharge destination | Discharge destination (home or rehabilitation facility) | 2-3 days post surgery | 
| Medium-term self-reported functional outcome measures - WOMAC | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measured at baseline and at 3 months post-operatively | baseline and 2-3 days post surgery | 
| Medium-term self-reported functional outcome measures - LEFS | Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively. | baseline and 2-3 days post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adductor Canal Block, Total Knee Arthroplasty