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The Efficacy of Long-Acting Nalbuphine Sebacate (Naldebain) for Pain Management After Knee Arthroplasty
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 .
Age
50 - 100 years
Sex
ALL
Healthy Volunteers
No
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
Start Date
April 6, 2022
Primary Completion Date
November 28, 2022
Completion Date
November 28, 2022
Last Updated
March 27, 2023
80
ACTUAL participants
Nalbuphine Sebacate (Naldebain)
DRUG
Placebo medication
DRUG
Lead Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
NCT05504577
NCT01333189
Data Source & Attribution
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