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NCT Number: NCT07140510

Dinalbuphine Sebacate in Postoperative Pain Control After TKA

To evaluate the effectiveness of Dinalbuphine Sebacate for controlling subacute pain after total knee arthroplasty

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Key information

Conditions

Osteo Arthritis of the Knee Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Total Knee Anthroplasty

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Thammasat University

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Location contact

Nattapol Tammachote, M.D.

PRINCIPAL_INVESTIGATOR

Supakit Kanitnate, M.D.

CONTACT

[email protected]

+66 899853635

About this study

A single dose of intramuscular Dinalbuphine Sebacate can mitigate pain for up to 1 week after TKA

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Osteoarthritic knee patients underwent unilateral primary TKA
  • Age 50-90 years
  • ASA class I-III
  • Participants understand and consent to the protocol of the trial

Exclusion criteria

  • Morbid obesity (BMI>40)
  • Knee osteoarthritis from inflammatory knee arthritis, trauma, infection
  • Previous knee surgery
  • Cognitive disorder
  • Liver disease
  • Allergy to NSAIDs, opioids, sesame oil, and benzyl benzoate
  • CYP3A4 inhibitor and inducer drugs used

Treatment and study plan

Dinalbuphine sebacate

Drug

Dinalbuphine Sebacate 150 mg intramuscular injection after spinal anesthesia and adductor canal block in the same side of TKA

normal saline

Drug

Normal saline 2 mL intramuscular injection after spinal anesthesia and adddutor canal block

Primary outcomes

  1. Visual analog scale for pain (VAS 0-100)

    Time frame: Record every 12 hours after surgery until 2 weeks postoperatively, then once weekly until 12 weeks postopertively

    Visual analog scale for pain at rest and on motion (knee flexion 90 degrees) using 0-100 mm, where a score of 0 represented no pain and 100 indicated the most severe pain

Secondary outcomes

  1. The amount of analgesic drug used

    Time frame: During hospitalization and at home until 12 weeks after surgery

    The amount of IV morphine and oral tramadol (milligram)

  2. Adverse effects

    Time frame: The first week after surgery

    Incidence of adverse effects including pyrexia, nausea, vomiting, dizziness, injection site pain, and somnolence

  3. Length of stay

    Time frame: During hospitalization (from admission to discharge)

    Length of stay (day)

  4. Modified WOMAC score

    Time frame: At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively

    Modified Western Ontario and McMaster Universities Osteoarthritis Index score, including total & subscore. Each item was scored with a Likert scale (0-4). The overall MOWAC was 0-96 (high score = worse symptoms)

  5. Forgotten Joint Score

    Time frame: At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively

    Forgotten Joint Score (Thai version) with 12 questions. Each item was scored on a Likert scale (0-4). The raw score was converted to a 0-100 scale (0 = worst, 100 = best)

  6. Time up and go (TUG) test

    Time frame: At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively

    Time up and go (TUG) test records the time in seconds when the patient starts standing up from the chair, then walks 3 meters at a normal pace, and turns around to sit on the chair.

  7. Knee range of motion

    Time frame: At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively

    Angle of knee flexion and extension in degrees using a long goniometer

Other outcomes

  1. Rate of closed manipulation

    Time frame: At 3 months postoperatively

    Closed manipulation under anesthesia due to an unsatisfactory range of motion

Study contacts

Contact information is provided by the study sponsor or research team.

Supakit Kanitnate, M.D.

CONTACT

[email protected]

+66 899853635

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

Effectiveness of Dinalbuphine Sebacate in Postoperative Pain Control Following Total Knee Arthroplasty: A Randomized Double Blinded Placebo-controlled Trial

Acronym: Naldebain

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

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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