Dinalbuphine Sebacate in Postoperative Pain Control After TKA

ConditionsOsteo Arthritis of the Knee Total Knee Anthroplasty

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age50-90

SponsorThammasat University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Morbid obesity (BMI>40)

Knee osteoarthritis from inflammatory knee arthritis, trauma, infection

Previous knee surgery

Cognitive disorder

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Dinalbuphine SebacateExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

Rate of closed manipulation

Closed manipulation under anesthesia due to an unsatisfactory range of motion

Time frame

At 3 months postoperatively

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thammasat University

Lead sponsor

Source ClinicalTrials.gov

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