An interventional study of Levobupivacaine Hydrochloride in Arthropathy, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Patient had no local analgesic agent during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.
Patient had periarticular local analgesic agent, LevoBupivacaine Hydrochloride, during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.
Drug: Levobupivacaine Hydrochloride
Patient had intra-articular local analgesic agent, LevoBupivacaine Hydrochloride, during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.
Drug: Levobupivacaine Hydrochloride
Different way of LevoBupivacaine injection
Also known as: Chirocaine
Dosage of analgesic opioid agent
The total dosage of opioid agent after local LevoBupivacaine injection
Time frame: post-operative day2
Blood concentration of LevoBupivacaine
Venous return of local LevoBupivacaine could cause the difference of blood concentration
Time frame: 25min, 90min, and coming morning after LevoBupivacaine injection
Functional score
The difference of functional score
Time frame: Baseline, Post-operative day1, day2, week2, week6, week12, week24
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital