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Completed

NCT Number: NCT03258697

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

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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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital, Linkou

Taoyuan City, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levobupivacaine hydrochloride

Drug

Different way of LevoBupivacaine injection

Other names: Chirocaine

Primary outcomes

  1. Dosage of analgesic opioid agent

    Time frame: post-operative day2

    The total dosage of opioid agent after local LevoBupivacaine injection

Secondary outcomes

  1. Blood concentration of LevoBupivacaine

    Time frame: 25min, 90min, and coming morning after LevoBupivacaine injection

    Venous return of local LevoBupivacaine could cause the difference of blood concentration

Other outcomes

  1. Functional score

    Time frame: Baseline, Post-operative day1, day2, week2, week6, week12, week24

    The difference of functional score

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 23, 2017
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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