Arthropathy of Knee Joint
Conditions
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 .
Interventions
DRUGNalbuphine Sebacate (Naldebain)
Nalbuphine Sebacate (Naldebain) 2mL/150mg would be intramuscularly injected during knee arthroplasty surgery.
Placebo medication, Nalbuphine Sebacate not contained
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine) | Post operation Day1 | morphine consumption amount |
| The level of pain index (Visual Analog Scale) | Baseline | pain level, Visual Analog Scale higher scores mean a worse outcome, 0\ 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index) | Baseline | knee joint functional data questionnaire |
Countries
Taiwan
Outcome results
None listed