To evaluate the effectiveness of Dinalbuphine Sebacate for controlling subacute pain after total knee arthroplasty
A single dose of intramuscular Dinalbuphine Sebacate can mitigate pain for up to 1 week after TKA
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Dinalbuphine Sebacate 150 mg intramuscular injection after spinal anesthesia and adductor canal block in the same side of TKA
Normal saline 2 mL intramuscular injection after spinal anesthesia and adddutor canal block
Thammasat University
Khlong Luang, Changwat Pathum Thani, Thailand
Visual analog scale for pain (VAS 0-100)
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
Time frame: Record every 12 hours after surgery until 2 weeks postoperatively, then once weekly until 12 weeks postopertively
The amount of analgesic drug used
The amount of IV morphine and oral tramadol (milligram)
Time frame: During hospitalization and at home until 12 weeks after surgery
Adverse effects
Incidence of adverse effects including pyrexia, nausea, vomiting, dizziness, injection site pain, and somnolence
Time frame: The first week after surgery
Length of stay
Length of stay (day)
Time frame: During hospitalization (from admission to discharge)
Modified WOMAC score
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)
Time frame: At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively
Forgotten Joint Score
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)
Time frame: At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively
Time up and go (TUG) test
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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.
Time frame: At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively
Knee range of motion
Angle of knee flexion and extension in degrees using a long goniometer
Time frame: At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively