search
Back to results

Naldebain for Pain Management After Knee Arthroplasty

Primary Purpose

Arthropathy of Knee Joint

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Nalbuphine Sebacate (Naldebain)
Placebo medication
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy of Knee Joint

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsiung Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group

Placebo Group

Arm Description

Nalbuphine Sebacate (Naldebain) intramuscular injection

Placebo medication intramuscular injection

Outcomes

Primary Outcome Measures

The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
morphine consumption amount
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
morphine consumption amount
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
morphine consumption amount
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
The level of pain index (Visual Analog Scale)
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10

Secondary Outcome Measures

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

Full Information

First Posted
February 20, 2022
Last Updated
March 23, 2023
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05266027
Brief Title
Naldebain for Pain Management After Knee Arthroplasty
Official Title
The Efficacy of Long-Acting Nalbuphine Sebacate (Naldebain) for Pain Management After Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
November 28, 2022 (Actual)
Study Completion Date
November 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Knee Joint

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Nalbuphine Sebacate (Naldebain) intramuscular injection
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Placebo medication intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Nalbuphine Sebacate (Naldebain)
Intervention Description
Nalbuphine Sebacate (Naldebain) 2mL/150mg would be intramuscularly injected during knee arthroplasty surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo medication
Intervention Description
Placebo medication, Nalbuphine Sebacate not contained
Primary Outcome Measure Information:
Title
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
Description
morphine consumption amount
Time Frame
Post operation Day1
Title
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
Description
morphine consumption amount
Time Frame
Post operation Day2
Title
The amount of painkillers used by the Patient Controlled Analgesia machine (PCA machine)
Description
morphine consumption amount
Time Frame
Post operation Day3
Title
The level of pain index (Visual Analog Scale)
Description
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
Time Frame
Baseline
Title
The level of pain index (Visual Analog Scale)
Description
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
Time Frame
Post operation Day1
Title
The level of pain index (Visual Analog Scale)
Description
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
Time Frame
Post operation Day2
Title
The level of pain index (Visual Analog Scale)
Description
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
Time Frame
Post operation Day3
Title
The level of pain index (Visual Analog Scale)
Description
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
Time Frame
Post operation Day4
Title
The level of pain index (Visual Analog Scale)
Description
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
Time Frame
Post operation Day5
Title
The level of pain index (Visual Analog Scale)
Description
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
Time Frame
Post operation 2 weeks
Title
The level of pain index (Visual Analog Scale)
Description
pain level, Visual Analog Scale higher scores mean a worse outcome, 0~10
Time Frame
Post operation 6 weeks
Secondary Outcome Measure Information:
Title
knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)
Description
knee joint functional data questionnaire
Time Frame
Baseline
Title
knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)
Description
knee joint functional data questionnaire
Time Frame
Post operation 2 weeks
Title
knee joint functional data questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)
Description
knee joint functional data questionnaire
Time Frame
Post operation 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsuan-Ti Huang, M.D.
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Naldebain for Pain Management After Knee Arthroplasty

We'll reach out to this number within 24 hrs