Efficacy of Pain Control in Different Bupivacaine Dose in Periarticular Injection in Bilateral Total Knee Arthroplasty

Study Overview
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Brief Summary
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To study efficacy of postoperative pain control of different concentrations of bupivacaine for periarticular infiltration, part of multimodal analgesia, in bilateral total knee arthroplasty. To study plasma concentration of bupivacaine in patient who received spinal anesthesia and single shot bilateral adductor canal block and periarticular infiltration with bupivacaine for safety level.

Detailed Description
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Adequate postoperative pain control reduce postoperative morbidity, multimodal analgesia techniques is used for achieve this goal. multimodal analgesia for bilateral total knee arthroplasty are peripheral nerve block, periarticular infiltration, NSAIDs, gabapentins and others. patients undergoing bilateral total knee arthroplasty in siriraj hospital receive spinal anesthesia, single shot bilateral adductor canal block and bilateral periarticular infiltration with bupivacaine so patient receive a large dose of bupivacaine. the investigators study the efficacy of postoperative pain of reduced dose of bupivacaine for periarticular infiltration. and study plasma level of bupivacaine.

Official Title
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Efficacy of Pain Management in Different Concentrations of Bupivacaine in Periarticular Injection and Plasma Concentrations of Bupivacaine in Patients Undergoing Bilateral Knee Arthroplasty

Conditions
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Bilateral Total Knee Arthroplasty

Intervention / Treatment
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* Procedure: bupivacaine 200 mg
* Drug: bupivacaine 100 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged more than 18 years old American society of anesthesiologists physical status classification 1-3 Undergoing bilateral total knee arthroplasty with spinal anesthesia and single shot bilateral adductor canal block Exclusion Criteria: Allergy to bupivacaine Body weight less than 50 kilograms Hepatic disease Coagulopathy Creatinine clearance less than 60 ml/min Uncontrolled cerebrovascular disease Hematocrit less than 35%

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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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bupivacaine 100 mg<br>bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add Normal saline solution(NSS) to 80 ml divided to two syringes for bilateral periarticular infiltration | Drug: bupivacaine 100 mg<br>* bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration<br>|
| Active Comparator: bupivacaine 200 mg<br>bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration | Procedure: bupivacaine 200 mg<br>* bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain score | Numerical rating scale at rest and movement in the first 24 hours postoperatively | 0-24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma bupivacaine level | plasma bupivacaine level at 40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltration | 40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltratio | 
| postoperative morphine consumption | postoperative morphine consumption at first 24 hours and 24-48 hours postoperatively | first 24 hours and 24-48 hours postoperatively | 
| ambulation | patient can walk with assistances within 48 hours postoperatively | 48 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periarticular infiltration, postoperative pain management, plasma level of bupivacaine