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NCT Number: NCT05266027

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 .

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Key information

Conditions

Arthropathy of Knee Joint

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nalbuphine Sebacate (Naldebain)

Drug

Nalbuphine Sebacate (Naldebain) 2mL/150mg would be intramuscularly injected during knee arthroplasty surgery.

Placebo medication

Drug

Placebo medication, Nalbuphine Sebacate not contained

Primary outcomes

  1. The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)

    Time frame: Post operation Day1

    morphine consumption amount

  2. The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)

    Time frame: Post operation Day2

    morphine consumption amount

  3. The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)

    Time frame: Post operation Day3

    morphine consumption amount

  4. The level of pain index (Visual Analog Scale)

    Time frame: Baseline

    pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10

  5. The level of pain index (Visual Analog Scale)

    Time frame: Post operation Day1

    pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10

  6. The level of pain index (Visual Analog Scale)

    Time frame: Post operation Day2

    pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10

  7. The level of pain index (Visual Analog Scale)

    Time frame: Post operation Day3

    pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10

  8. The level of pain index (Visual Analog Scale)

    Time frame: Post operation Day4

    pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10

  9. The level of pain index (Visual Analog Scale)

    Time frame: Post operation Day5

    pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10

  10. The level of pain index (Visual Analog Scale)

    Time frame: Post operation 2 weeks

    pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10

  11. The level of pain index (Visual Analog Scale)

    Time frame: Post operation 6 weeks

    pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10

Secondary outcomes

  1. knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)

    Time frame: Baseline

    knee joint functional data questionnaire

  2. knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)

    Time frame: Post operation 2 weeks

    knee joint functional data questionnaire

  3. knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)

    Time frame: Post operation 6 weeks

    knee joint functional data questionnaire

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2022
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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