NCT03258697

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Arthropathy

Interventions

Type	Name	Description
DRUG	Levobupivacaine Hydrochloride	Different way of LevoBupivacaine injection

Timeline

• Start date: 2017-10-17
• Primary completion: 2019-01-31
• Completion: 2019-05-31
• First posted: 2017-08-23
• Last updated: 2024-06-04

Locations

1 site across 1 country: Taiwan