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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-17

Study Completion Date

2019-05-31

Brief Summary

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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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Detailed Description

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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

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Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. PCA only
2. Peri-articular Levobupivacaine + PCA
3. Intra-articular Levobupivacaine + PCA

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Patient blinded, observer blinded study

Study Groups

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Patient-Controlled Analgesia

Patient had no local analgesic agent during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.

Group Type NO_INTERVENTION

No interventions assigned to this group

Peri-articular LevoBupivacaine

Patient had periarticular local analgesic agent, LevoBupivacaine Hydrochloride, during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.

Group Type ACTIVE_COMPARATOR

Levobupivacaine Hydrochloride

Intervention Type DRUG

Different way of LevoBupivacaine injection

Intra-articular LevoBupivacaine

Patient had intra-articular local analgesic agent, LevoBupivacaine Hydrochloride, during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.

Group Type EXPERIMENTAL

Levobupivacaine Hydrochloride

Intervention Type DRUG

Different way of LevoBupivacaine injection

Interventions

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Levobupivacaine Hydrochloride

Different way of LevoBupivacaine injection

Intervention Type DRUG

Other Intervention Names

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Chirocaine

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No