Systemic Lidocaine Versus Ultrasound-guided Adductor Canal Block for Patients Undergoing Total Knee Arthroplasty

Study Overview
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Brief Summary
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The investigators are evaluating the postoperative outcomes in patients undergoing total knee arthroplasty that receive either systemic lidocaine or ultrasound-guided adductor canal block as part of their anesthetic plan.

Detailed Description
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Patients scheduled to have total knee arthroplasty will typically receive a single shot adductor canal block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. The use of adductor canal block is still limited to where trained anesthesiologists in regional anesthesia are available. There are other nonopioid analgesic adjuncts, such as Lidocaine, which is is widely available and is a very commonly used local anesthetic. A major advantage of lidocaine is that it is not associated with a significant side effect profile. Intravenous lidocaine which can be administered during surgery and/or after surgery has demonstrated anti-inflammatory effects and can significantly decrease the reliance on opioid use for adequate pain management in abdominal and spine surgeries. The addition of systemic lidocaine infusion as part of a multimodal analgesia strategy to minimize opioid related side effects might prove to be a useful combination for clinicians where adductor canal blocks are not a viable option. However, the level of evidence comparing the efficacy of intravenous lidocaine versus adductor canal block to reduce postoperative opioid consumption in patients undergoing TKA is limited. We hypothesized that there will be no meaningful clinical difference between systemic lidocaine and ultrasound-guided adductor canal block in the 24-hour postoperative analgesia period.

Official Title
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The Efficacy of Systemic Lidocaine Versus Ultrasound-guided Adductor Canal Block for Patients Undergoing Total Knee Arthroplasty: a Randomized, Double-blinded, Non-inferiority Study

Conditions
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Arthroplasty, Replacement, Knee, Total Knee Arthroplasty

Intervention / Treatment
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* Drug: Lidocaine IV
* Drug: Saline IV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA PS 1-3 patients undergoing primary, unilateral total knee arthroplasty Exclusion Criteria: ASA PS classification of 4 or greater Pre-existing neuropathy Coagulopathy Chronic opioid consumption (>3 months) Infection at the site Known allergy to study medications (lidocaine) High grade atrioventricular block (cardiac conduction system impairment) A history of CVA/TIA Currently using lidocaine patches Known liver disease

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound-guided adductor canal block with local anesthetic<br>Single shot Ultrasound-guided adductor canal block with 0.5% ropivacaine 30 ml | Drug: Saline IV<br>* Intravenous saline of 1.5 mg/kg bolus followed by a 1.5 mg/kg/h infusion continuing to the end of phase 1 of post anesthesia care unit<br>* Other names: Sodium chloride;|
| Sham Comparator: Ultrasound-guided adductor canal block with saline<br>Single shot Ultrasound-guided adductor canal block with 30 mL of normal saline (Sodium chloride) | Drug: Lidocaine IV<br>* Intravenous lidocaine of 1.5 mg/kg bolus followed by a 1.5 mg/kg/h infusion continuing to the end of phase 1 of post anesthesia care unit<br>* Other names: Lidocaine Hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid consumption | Postoperative opioid consumption will be converted to equivalent dose of oral morphine. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | Patients were asked to rate their pain score during activity on a 11-point scale (0 = no pain to 10 = excruciating pain). | up to 2 hours (post anesthesia recovery unit), 6 hours, 12 hours, and 24 hours after surgery. | 
| Quality of Recovery | The QoR-15 questionnaire has 15 questions that assess patient-reported quality of a patient's postoperative recovery using a 11-point numerical rating scale that leads to a minimum score of 0 (poor recovery) and a maximum score of 150 (excellent recovery). | 24 hours |