Clinical trial NCT05266027: Naldebain for Pain Management After Knee Arthroplasty
Official title: The Efficacy of Long-Acting Nalbuphine Sebacate (Naldebain) for Pain Management After Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthropathy of Knee Joint
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 .

Eligibility criteria: 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

Primary outcomes:
measure: The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
timeFrame: Post operation Day1
measure: The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
timeFrame: Post operation Day2
measure: The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
timeFrame: Post operation Day3
measure: The level of pain index (Visual Analog Scale)
timeFrame: Baseline
measure: The level of pain index (Visual Analog Scale)
timeFrame: Post operation Day1
measure: The level of pain index (Visual Analog Scale)
timeFrame: Post operation Day2
measure: The level of pain index (Visual Analog Scale)
timeFrame: Post operation Day3
measure: The level of pain index (Visual Analog Scale)
timeFrame: Post operation Day4
measure: The level of pain index (Visual Analog Scale)
timeFrame: Post operation Day5
measure: The level of pain index (Visual Analog Scale)
timeFrame: Post operation 2 weeks
measure: The level of pain index (Visual Analog Scale)
timeFrame: Post operation 6 weeks
Secondary outcomes:
measure: knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)
timeFrame: Baseline
measure: knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)
timeFrame: Post operation 2 weeks
measure: knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)
timeFrame: Post operation 6 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
affiliation: Kaohsiung Medical University
name: Hsuan-Ti Huang, M.D.
role: STUDY_DIRECTOR
References: