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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 .
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Nalbuphine Sebacate (Naldebain) intramuscular injection |
|
| Placebo Group | Placebo Comparator | Placebo medication intramuscular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalbuphine Sebacate (Naldebain) | Drug | Nalbuphine Sebacate (Naldebain) 2mL/150mg would be intramuscularly injected during knee arthroplasty surgery. |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hsuan-Ti Huang, M.D. | Kaohsiung Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Hospital | Kaohsiung City | 807 | Taiwan |
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| Placebo medication | Drug | Placebo medication, Nalbuphine Sebacate not contained |
|
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 |
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 |