Naldebain for Pain Management After Knee Arthroplasty

Kaohsiung Medical University

Status and phase

Completed

Phase 4

Conditions

Arthropathy of Knee Joint

Treatments

Drug: Placebo medication

Drug: Nalbuphine Sebacate (Naldebain)

Study type

Interventional

Funder types

Other

Identifiers

NCT05266027

KMUHIRB-F(I)-20210150

Details and patient eligibility

About

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 .

Full 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 .

Enrollment

80 patients

Sex

All

Ages

50 to 100 years old

Volunteers

No Healthy Volunteers

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