Naldebain for Pain Management After Knee Arthroplasty

Study Overview
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Brief Summary
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Naldebain, a long-acting analgesic injection, obtained a license from the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare on March 6, 2017 to approve a sustained-release long-acting analgesic on the market in Taiwan. This study hopes to use a rigorous double-blind randomized controlled experiment to understand whether the new sustained-release analgesic Naldebain can achieve effective pain relief for patients undergoing knee replacement surgery, and to evaluate the patient's functional recovery status .

Detailed Description
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Naldebain, a long-acting analgesic injection, obtained a license from the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare on March 6, 2017 to approve a sustained-release long-acting analgesic on the market in Taiwan. At present, it is the only analgesic injection that has an efficacy of up to seven days. The currently approved drug indication is to relieve moderate and severe acute pain after surgery. Pharmacological mechanisms and experiments show that its analgesic effect is equivalent to morphine, but its side effects are much lower than morphine. Because of its special pharmacological mechanism, it has extremely high potential to improve patients undergoing knee replacement surgery. Therefore, this study hopes to use a rigorous double-blind randomized controlled experiment to understand whether the new sustained-release analgesic Naldebain can achieve effective pain relief for patients undergoing knee replacement surgery, and to evaluate the patient's functional recovery status .

Official Title
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The Efficacy of Long-Acting Nalbuphine Sebacate (Naldebain) for Pain Management After Knee Arthroplasty

Conditions
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Arthropathy of Knee Joint

Intervention / Treatment
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* Drug: Nalbuphine Sebacate (Naldebain)
* Drug: Placebo medication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at least 50 years old, not exceed 100 years old Diagnosed Primary Knee Osteoarthritis accepted Knee Arthroplasty Exclusion Criteria: Diagnosed inflammatory Arthritis、Rheumatoid Arthritis Accepted Revision Knee Arthroplasty Patients with head injury, intracranial injury, increased intracerebral pressure and liver insufficiency Patients who are allergic to nalbuphine sebacate, nalbuphine, sesame oil or benzyl benzoate drugs

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Nalbuphine Sebacate (Naldebain) intramuscular injection | Drug: Nalbuphine Sebacate (Naldebain)<br>* Nalbuphine Sebacate (Naldebain) 2mL/150mg would be intramuscularly injected during knee arthroplasty surgery.<br>|
| Placebo Comparator: Placebo Group<br>Placebo medication intramuscular injection | Drug: Placebo medication<br>* Placebo medication, Nalbuphine Sebacate not contained<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine) | morphine consumption amount | Post operation Day1 | 
| The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine) | morphine consumption amount | Post operation Day2 | 
| The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine) | morphine consumption amount | Post operation Day3 | 
| The level of pain index (Visual Analog Scale) | pain level, Visual Analog Scale higher scores mean a worse outcome, 0 10 | Baseline | 
| The level of pain index (Visual Analog Scale) | pain level, Visual Analog Scale higher scores mean a worse outcome, 0 10 | Post operation Day1 | 
| The level of pain index (Visual Analog Scale) | pain level, Visual Analog Scale higher scores mean a worse outcome, 0 10 | Post operation Day2 | 
| The level of pain index (Visual Analog Scale) | pain level, Visual Analog Scale higher scores mean a worse outcome, 0 10 | Post operation Day3 | 
| The level of pain index (Visual Analog Scale) | pain level, Visual Analog Scale higher scores mean a worse outcome, 0 10 | Post operation Day4 | 
| The level of pain index (Visual Analog Scale) | pain level, Visual Analog Scale higher scores mean a worse outcome, 0 10 | Post operation Day5 | 
| The level of pain index (Visual Analog Scale) | pain level, Visual Analog Scale higher scores mean a worse outcome, 0 10 | Post operation 2 weeks | 
| The level of pain index (Visual Analog Scale) | pain level, Visual Analog Scale higher scores mean a worse outcome, 0 10 | Post operation 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index) | knee joint functional data questionnaire | Baseline | 
| knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index) | knee joint functional data questionnaire | Post operation 2 weeks | 
| knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index) | knee joint functional data questionnaire | Post operation 6 weeks |