Overview

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

Status:
Unknown status
Trial end date:
2020-02-28
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chang Gung Memorial Hospital
Treatments:
Bupivacaine
Levobupivacaine
Criteria
Inclusion Criteria:

1. Primary total joint replacement, no previous open surgery on the same joint

2. Age 50~80 y/o, Pre-operative diagnosis: degenerative osteoarthritis

3. Pre-operative deformity: varus <15°, valgus <15°, flexion contracture <15°.

4. Patients with normal heart function

5. Willing to receive post-operative questionnaire and outpatient clinic follow-up

Exclusion Criteria:

1. Allergy to Patient-Controlled Analgesia or LevoBupivacaine

2. Mental or cognitive illness that couldn't well response to questionnaire

3. American Society Anesthesiologist more than III degree

4. Liver cirrhosis, chronic renal insufficiency, heart disease or arrhythmia,
insulin-dependent diabetes mellitus, and previous narcotic abuse history.

5. Not suitable for using patient-controlled analgesia pump by evaluation of
anesthesiologist