Chang Gung Memorial Hospital, Linkou
Taoyuan City, 333, Taiwan
NCT Number: NCT03258697
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.
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Notify Me50 year–80 year
All sexes
Interventional
Not applicable
Taoyuan City, 333, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Different way of LevoBupivacaine injection
Other names: Chirocaine
Time frame: post-operative day2
The total dosage of opioid agent after local LevoBupivacaine injection
Time frame: 25min, 90min, and coming morning after LevoBupivacaine injection
Venous return of local LevoBupivacaine could cause the difference of blood concentration
Time frame: Baseline, Post-operative day1, day2, week2, week6, week12, week24
The difference of functional score
Chang Gung Memorial Hospital
Other
The Pharmacokinetics and Effectiveness of Different Methods of Local LevoBupivacaine Injection, a Prospective Randomized Case Control Clinical Study on Primary Total Joint Replacement Model.
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