Low Versus Standard Concentrations and Volumes Local Anesthetics Boluses for Continuous Adductor Canal Block Under Ultrasound-guidance in Total Knee Arthroplasty

Study Overview
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Brief Summary
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Total knee arthroplasty (TKA) is a commonly performed surgical procedure for patients with severe knee osteoarthritis. However, one of the challenges associated with total knee arthroplasty is the significant postoperative pain experienced by patients, which can delay early mobilization and physical therapy. Uncontrolled pain worsens patient outcomes and healthcare costs as it can increase the risk of complications after surgery. Therefore, effective pain management is important for optimizing patient outcomes and promoting a smooth recovery process. The aim of this study is to investigate the efficacy of two different regimens of bupivacaine used in boluses for continuous adductor canal block under ultrasound-guidance in total knee arthroplasty at King Chulalongkorn Memorial Hospital.

Official Title
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Low Versus Standard Concentrations and Volumes Local Anesthetics Boluses for Continuous Adductor Canal Block Under Ultrasound-guidance in Total Knee Arthroplasty: A Randomized Controlled Trial

Conditions
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Knee Arthropathy

Intervention / Treatment
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* Drug: Low and standard concentrations and volumes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing TKA aged more than 18 years Patients with American Society of Anesthesiologists (ASA) class 1-3 Patients with body weight index (BMI) 18-40 kg/m2 Exclusion Criteria Patient refusal to participate Patients with known allergic to medications used in the research protocol Patients with contraindications to neuraxial or regional anesthesia, including existing neuropathy or neurological deficits involving the lower extremities, coagulopathy or bleeding diathesis and local skin infections Patients with contraindications to NSAIDs such as history of coronary artery bypass graft surgery, congestive heart failure, stroke, gastrointestinal bleedings or ulceration, asthma, hepatic and renal disease, abnormal coagulation, or pregnancy Patients with chronic opioid use (opioids have been used daily or almost daily for more than three months or sixty milligrams or more of morphine has been used daily for more than one month) or diagnosed with neuropathic pain Patients that are unable to perform preoperative Quantitative sensory testing.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Concentration and Volume<br>0.15% bupivacaine 10 ml boluses for continuous adductor canal block | Drug: Low and standard concentrations and volumes<br>* Compare low and standard concentrations and volumes of bupivacaine boluses for continuous adductor block<br>|
| Placebo Comparator: Standard Concentration and Volume<br>0.25% bupivacaine 20 ml boluses for continuous adductor canal block | Drug: Low and standard concentrations and volumes<br>* Compare low and standard concentrations and volumes of bupivacaine boluses for continuous adductor block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average knee pain score assessed by NRS | Average postoperative pain score assessed by NRS from 0-10 | 12 hours after surgery | 
| Change in Quadriceps strength assessed by maximum voluntary isometric contraction (MVIC) in Newton | Compare the quadriceps strength in Newton by MVIC between preoperative period and postoperative day 1 | preoperative - 12 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction assessed by NRS | Evaluate patient satisfaction by NRS from 0-10 before discharge from the hospital and 7 days after hospital discharge | 60 hours after surgery - 7 days after hospital discharge | 
| Length of hospital stay assessed by hours | Evaluate length of hospital stay (from admission to hospital discharge) by hours | 60 hours after surgery | 
| Functional outcomes assessed by Knee Society Score (KSS), Five Times Sit to Stand Test (5XSST) , Time Up and Go (TUG) | Evaluate patient's functional outcomes by KSS, 5XSST, TUG tests at preoperative and postoperative day 0,1,2 | preoperative - postoperative day 2 | 
| Postoperative pain score assessed by NRS | Postoperative pain score at rest and on movement assessed by NRS from 0-10 at preoperative, 0,12,24,36,48,60 hours postoperatively, day 1-7 after hospital discharge | preoperative - day 7 after hospital discharge | 
| Quadriceps strength assessed by maximum voluntary isometric contraction (MVIC) in Newton | Quadriceps strength assessed by MVIC in Newton at 90 degrees at preoperative and postoperative day 0,1,2 | preoperative - postoperative day 2 | 
| morphine consumption in milligrams | Patient's morphine consumption at postoperative day 0,1,2 | postperative day 0-2 | 
| postoperative complications assessed by Likert scale | postoperative complications such as nausea/vomitting, sleep disturbance and fall assessed by Likert scale from 1-7 | postperative day 0-2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adductor canal block, femoral nerve block, local infiltration analgesia, Postoperative pain management, Quadriceps strength, Total knee arthroplasty