Dinalbuphine Sebacate in Postoperative Pain Control After TKA

Not Applicable

Not yet recruiting

• Conditions: Osteo Arthritis of the Knee; Total Knee Anthroplasty
• Interventions: Drug: Dinalbuphine Sebacate; Drug: Normal Saline

• Registration Number: NCT07140510
• Lead Sponsor: Thammasat University

Brief Summary

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

Detailed Description

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

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-03
• Study First Submitted QC: 2025-08-18
• Last Update Submitted: 2025-08-18
• Study First Posted: 2025-08-24
• Last Update Posted: 2025-08-24
• Study Start: 2025-10-01
• Primary Completion: 2026-06
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dinalbuphine Sebacate	Dinalbuphine Sebacate	Naldebain 150mg/2mL IM
Placebo	Normal Saline	Normal saline 2 mL IM

Primary Outcome Measures

Name	Time	Method
Visual analog scale for pain (VAS 0-100)	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 Outcome Measures

Name	Time	Method
The amount of analgesic drug used	During hospitalization and at home until 12 weeks after surgery	The amount of IV morphine and oral tramadol (milligram)
Modified WOMAC score	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)
Adverse effects	The first week after surgery	Incidence of adverse effects including pyrexia, nausea, vomiting, dizziness, injection site pain, and somnolence
Time up and go (TUG) test	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.
Knee range of motion	At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively	Angle of knee flexion and extension in degrees using a long goniometer
Length of stay	During hospitalization (from admission to discharge)	Length of stay (day)
Forgotten Joint Score	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)

Trial Locations

Locations (1)

Thammasat University; 🇹🇭 Khlong Luang, Pathum Thani, Thailand