Dinalbuphine Sebacate in Postoperative Pain Control After TKA (Naldebain)

August 18, 2025 updated by: Supakit Kanitnate, Thammasat University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
    • Pathum Thani
      • Khlong Luang, Pathum Thani, Thailand, 12120
        • Thammasat University
        • Principal Investigator:
          • Nattapol Tammachote, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dinalbuphine Sebacate
Naldebain 150mg/2mL IM
Drug: Dinalbuphine Sebacate
Dinalbuphine Sebacate 150 mg intramuscular injection after spinal anesthesia and adductor canal block in the same side of TKA
Placebo Comparator: Placebo
Normal saline 2 mL IM
Drug: Normal Saline
Normal saline 2 mL intramuscular injection after spinal anesthesia and adddutor canal block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Record every 12 hours after surgery until 2 weeks postoperatively, then once weekly until 12 weeks postopertively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
During hospitalization and at home until 12 weeks after surgery
Adverse effects
Time Frame: The first week after surgery
Incidence of adverse effects including pyrexia, nausea, vomiting, dizziness, injection site pain, and somnolence
The first week after surgery
Length of stay
Time Frame: During hospitalization (from admission to discharge)
Length of stay (day)
During hospitalization (from admission to discharge)
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)
At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively
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)
At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively
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.
At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively
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
At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of closed manipulation
Time Frame: At 3 months postoperatively
Closed manipulation under anesthesia due to an unsatisfactory range of motion
At 3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 3, 2025

First Submitted That Met QC Criteria

August 18, 2025

First Posted (Actual)

August 24, 2025

Study Record Updates

Last Update Posted (Actual)

August 24, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OrthoTU14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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