Naldebain for Pain Management After Knee Arthroplasty

Arthropathy of Knee Joint Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05266027
• Other study ID #: KMUHIRB-F(I)-20210150
• Status: Completed
• Phase: Phase 4
• Start date: April 6, 2022
• Est. completion date: November 28, 2022

Study information

• Verified date: November 2022
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 28, 2022
• Est. primary completion date: November 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Knee Joint
• Joint Diseases

Intervention

Drug:
• Nalbuphine Sebacate (Naldebain)
Nalbuphine Sebacate (Naldebain) 2mL/150mg would be intramuscularly injected during knee arthroplasty surgery.
• Placebo medication
Placebo medication, Nalbuphine Sebacate not contained

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)	morphine consumption amount	Post operation Day1
Primary	The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)	morphine consumption amount	Post operation Day2
Primary	The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)	morphine consumption amount	Post operation Day3
Primary	The level of pain index (Visual Analog Scale)	pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10	Baseline
Primary	The level of pain index (Visual Analog Scale)	pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10	Post operation Day1
Primary	The level of pain index (Visual Analog Scale)	pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10	Post operation Day2
Primary	The level of pain index (Visual Analog Scale)	pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10	Post operation Day3
Primary	The level of pain index (Visual Analog Scale)	pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10	Post operation Day4
Primary	The level of pain index (Visual Analog Scale)	pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10	Post operation Day5
Primary	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
Primary	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	knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)	knee joint functional data questionnaire	Baseline
Secondary	knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)	knee joint functional data questionnaire	Post operation 2 weeks
Secondary	knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)	knee joint functional data questionnaire	Post operation 6 weeks