Naldebain for Pain Management After Knee Arthroplasty

• Status: Recruiting
• Trial end date: 2024-10-31
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Treatments: Nalbuphine

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