Dinalbuphine Sebacate in Postoperative Pain Control After TKA (Naldebain)

Thammasat University

Status and phase: Not yet enrolling; Phase 4

Conditions: Osteo Arthritis of the Knee; Total Knee Anthroplasty

Treatments: Drug: Normal Saline; Drug: Dinalbuphine Sebacate

Study type: Interventional

Funder types: Other

Identifiers

NCT07140510

OrthoTU14

Details and patient eligibility

About

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

Full description

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

Enrollment: 100 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Dinalbuphine Sebacate

Experimental group

Description:

Naldebain 150mg/2mL IM

Treatment:

Drug: Dinalbuphine Sebacate

Placebo

Placebo Comparator group

Description:

Normal saline 2 mL IM

Treatment:

Drug: Normal Saline