Osteo Arthritis of the Knee, Total Knee Anthroplasty
Conditions
Keywords
Dinalbuphine Sebacate, Naldebain, Subacute pain, postoperative pain, total knee arthroplasty
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
Interventions
Dinalbuphine Sebacate 150 mg intramuscular injection after spinal anesthesia and adductor canal block in the same side of TKA
DRUGNormal Saline
Normal saline 2 mL intramuscular injection after spinal anesthesia and adddutor canal block
Sponsors
Thammasat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Adverse effects | The first week after surgery | Incidence of adverse effects including pyrexia, nausea, vomiting, dizziness, injection site pain, and somnolence |
| 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) |
| 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 |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of closed manipulation | At 3 months postoperatively | Closed manipulation under anesthesia due to an unsatisfactory range of motion |
Countries
Thailand
Contacts
Primary ContactSupakit Kanitnate, M.D.
Outcome results
None listed