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 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Nalbuphine Sebacate (Naldebain) 2mL/150mg would be intramuscularly injected during knee arthroplasty surgery.
Placebo medication, Nalbuphine Sebacate not contained
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
morphine consumption amount
Time frame: Post operation Day1
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
morphine consumption amount
Time frame: Post operation Day2
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
morphine consumption amount
Time frame: Post operation Day3
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0\~10
Time frame: Baseline
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0\~10
Time frame: Post operation Day1
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0\~10
Time frame: Post operation Day2
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0\~10
Time frame: Post operation Day3
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0\~10
Time frame: Post operation Day4
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The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0\~10
Time frame: Post operation Day5
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0\~10
Time frame: 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
Time frame: Post operation 6 weeks
knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)
knee joint functional data questionnaire
Time frame: Baseline
knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)
knee joint functional data questionnaire
Time frame: Post operation 2 weeks
knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)
knee joint functional data questionnaire
Time frame: Post operation 6 weeks