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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258697
Recruitment Status : Unknown
Verified August 2017 by Chang Gung Memorial Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : August 23, 2017
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Arthropathy Drug: Levobupivacaine Hydrochloride Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders

Arm Intervention/treatment
No Intervention: Patient-Controlled Analgesia
Patient had no local analgesic agent during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.
Active Comparator: Peri-articular LevoBupivacaine
Patient had periarticular local analgesic agent, LevoBupivacaine Hydrochloride, during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.
Drug: Levobupivacaine Hydrochloride
Different way of LevoBupivacaine injection
Other Name: Chirocaine

Experimental: Intra-articular LevoBupivacaine
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
Other Name: Chirocaine




Primary Outcome Measures :
  1. Dosage of analgesic opioid agent [ Time Frame: post-operative day2 ]
    The total dosage of opioid agent after local LevoBupivacaine injection


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Functional score [ Time Frame: Baseline, Post-operative day1, day2, week2, week6, week12, week24 ]
    The difference of functional score



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258697


Locations
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Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan City, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Wei-Chen Lo, M.S. Chang Gung Memorial Hospital, Linkou, Taiwan
Publications:
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03258697    
Other Study ID Numbers: 201602050A3
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Chang Gung Memorial Hospital:
Local analgesia, Pharmacokinetics, Total joint replacement
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents