Status:

COMPLETED

Naldebain for Pain Management After Knee Arthroplasty

Lead Sponsor:

Kaohsiung Medical University Chung-Ho Memorial Hospital

Conditions:

Arthropathy of Knee Joint

Eligibility:

All Genders

50-100 years

Phase:

PHASE4

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-relea...

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-relea...

Eligibility Criteria

Inclusion

  • Age at least 50 years old, not exceed 100 years old
  • Diagnosed Primary Knee Osteoarthritis accepted Knee Arthroplasty

Exclusion

  • 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

Key Trial Info

Start Date :

April 6 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 28 2022

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT05266027

Start Date

April 6 2022

End Date

November 28 2022

Last Update

March 27 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan, 807