Naldebain for Pain Management After Knee Arthroplasty

Phase 4

Completed

• Conditions: Arthropathy of Knee Joint
• Interventions: Drug: Nalbuphine Sebacate (Naldebain); Drug: Placebo medication

• Registration Number: NCT05266027
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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 .

Study Timeline

• Study First Submitted: 2022-02-20
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-04
• Study Start: 2022-04-06
• Status Verified: 2022-11
• Primary Completion: 2022-11-28
• Study Completion: 2022-11-28
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Nalbuphine Sebacate (Naldebain)	Nalbuphine Sebacate (Naldebain) intramuscular injection
Placebo Group	Placebo medication	Placebo medication intramuscular injection

Primary Outcome Measures

Name	Time	Method
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)	Post operation Day3	morphine consumption amount
The level of pain index (Visual Analog Scale)	Post operation 6 weeks	pain level, Visual Analog Scale higher scores mean a worse outcome, 0\~10

Secondary Outcome Measures

Name	Time	Method
knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)	Post operation 6 weeks	knee joint functional data questionnaire

Trial Locations

Locations (1)

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan