Naldebain for Pain Management After Knee Arthroplasty

The Efficacy of Long-Acting Nalbuphine Sebacate (Naldebain) for Pain Management After Knee Arthroplasty

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 .

Study Overview

• Status: Completed
• Conditions: Arthropathy of Knee Joint
• Intervention / Treatment: Drug: Nalbuphine Sebacate (Naldebain); Drug: Placebo medication

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Nalbuphine Sebacate (Naldebain) intramuscular injection	Drug: Nalbuphine Sebacate (Naldebain); Nalbuphine Sebacate (Naldebain) 2mL/150mg would be intramuscularly injected during knee arthroplasty surgery.
Placebo Comparator: Placebo Group; Placebo medication intramuscular injection	Drug: Placebo medication; Placebo medication, Nalbuphine Sebacate not contained

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)	morphine consumption amount	Post operation Day1
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)	morphine consumption amount	Post operation Day2
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)	morphine consumption amount	Post operation Day3
The level of pain index (Visual Analog Scale)	pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10	Baseline
The level of pain index (Visual Analog Scale)	pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10	Post operation Day1
The level of pain index (Visual Analog Scale)	pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10	Post operation Day2
The level of pain index (Visual Analog Scale)	pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10	Post operation Day3
The level of pain index (Visual Analog Scale)	pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10	Post operation Day4
The level of pain index (Visual Analog Scale)	pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10	Post operation Day5
The level of pain index (Visual Analog Scale)	pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10	Post operation 2 weeks
The level of pain index (Visual Analog Scale)	pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10	Post operation 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)	knee joint functional data questionnaire	Baseline
knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)	knee joint functional data questionnaire	Post operation 2 weeks
knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)	knee joint functional data questionnaire	Post operation 6 weeks

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Study Director: Hsuan-Ti Huang, M.D., Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Actual): November 28, 2022
• Study Completion (Actual): November 28, 2022

Study Registration Dates

• First Submitted: February 20, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Nalbuphine
• Other Study ID Numbers: KMUHIRB-F(I)-20210150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No