The Pharmacokinetics and Effectiveness of Local LevoBupivacaine Injection on Primary Total Joint Replacement Model.

Study Overview
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Brief Summary
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Total joint replacement is an ideal procedure to treat end stage joint disease. Good post-op pain relief could accelerate patient recovery and rehabilitation, and decrease admission days and medical cost. Local injection of LevoBupivacaine is an effective method in post-operative pain control. The effectiveness of local analgesia was noticed clinically. However, thorough studies about the pharmacokinetics of LevoBupivacaine, maintenance of effect, influence of post-operative rehabilitation are not well studied in different way of injection. The purpose of this study is to evaluate and analyze the pharmacokinetics and effect of local Levobupivacaine injection in different ways, the amount of post-operative fentanyl requirement after local injection, time to first fentanyl request, pain score, immediate post-operative function, side effect of analgesic agents, and medical cost, and to improve the quality of total joint replacement post-operative care.

Detailed Description
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Single large dose of LevoBupivacaine had been proved good analgesic effect in total joint replacement surgery. However, the safety was not well studied. For better understanding the effect and safety of local analgesic agent, we choose LevoBupivacaine with different injection way to find out. We divide patient to three groups, for comparing the effectiveness of LevoBupivacaine, and safety of LevoBupivacaine by checking intra-blood concentration. The pre-emptive analgesics and post-operative analgesics were the same as routine protocol in other total joint replacement.

Official Title
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The Pharmacokinetics and Effectiveness of Different Methods of Local LevoBupivacaine Injection, a Prospective Randomized Case Control Clinical Study on Primary Total Joint Replacement Model.

Conditions
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Arthropathy

Intervention / Treatment
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* Drug: Levobupivacaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary total joint replacement, no previous open surgery on the same joint Age 50 80 y/o, Pre-operative diagnosis: degenerative osteoarthritis Pre-operative deformity: varus <15°, valgus <15°, flexion contracture <15°. Patients with normal heart function Willing to receive post-operative questionnaire and outpatient clinic follow-up Exclusion Criteria: Allergy to Patient-Controlled Analgesia or LevoBupivacaine Mental or cognitive illness that couldn't well response to questionnaire American Society Anesthesiologist more than III degree Liver cirrhosis, chronic renal insufficiency, heart disease or arrhythmia, insulin-dependent diabetes mellitus, and previous narcotic abuse history. Not suitable for using patient-controlled analgesia pump by evaluation of anesthesiologist

Ages Eligible for Study
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Minimum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Patient-Controlled Analgesia<br>Patient had no local analgesic agent during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump. | |
| Active Comparator: Peri-articular LevoBupivacaine<br>Patient had periarticular local analgesic agent, LevoBupivacaine Hydrochloride, during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump. | Drug: Levobupivacaine Hydrochloride<br>* Different way of LevoBupivacaine injection<br>* Other names: Chirocaine;|
| Experimental: Intra-articular LevoBupivacaine<br>Patient had intra-articular local analgesic agent, LevoBupivacaine Hydrochloride, during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump. | Drug: Levobupivacaine Hydrochloride<br>* Different way of LevoBupivacaine injection<br>* Other names: Chirocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of analgesic opioid agent | The total dosage of opioid agent after local LevoBupivacaine injection | post-operative day2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood concentration of LevoBupivacaine | Venous return of local LevoBupivacaine could cause the difference of blood concentration | 25min, 90min, and coming morning after LevoBupivacaine injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Local analgesia, Pharmacokinetics, Total joint replacement