Naldebain for Pain Management After Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-06

Study Completion Date

2022-11-28

Brief Summary

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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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Detailed Description

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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 .

Conditions

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Arthropathy of Knee Joint

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Experimental Group

Nalbuphine Sebacate (Naldebain) intramuscular injection

Group Type EXPERIMENTAL

Nalbuphine Sebacate (Naldebain)

Intervention Type DRUG

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

Placebo Group

Placebo medication intramuscular injection

Group Type PLACEBO_COMPARATOR

Placebo medication

Intervention Type DRUG

Placebo medication, Nalbuphine Sebacate not contained

Interventions

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Nalbuphine Sebacate (Naldebain)

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

Intervention Type DRUG

Placebo medication

Placebo medication, Nalbuphine Sebacate not contained

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No